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Europe against Cancer: Optimisation of the Use of Registries for Scientific Excellence in research

Final Report Summary - EUROCOURSE (Europe against Cancer: Optimisation of the Use of Registries for Scientific Excellence in research)

Executive summary:

EUROCOURSE: Europe against Cancer: Optimisation of the Use of Registries for Scientific Excellence in research

The main purpose of the project was to improve the development and use of cancer registries across Europe through information exchange and benchmarking of best registry practices including research programming and connecting researchers with their program owners, like cancer leagues, provincial and national ministries of Health, comprehensive cancer centres, institutes of public health and universities. Besides there is a marked executive role for health insurance companies, in practice irregularly in a shifting mode and with overlapping responsibilities. More specific, EUROCOURSE aimed to address both the performance and vital shortcomings and problems of the 175+ population-based cancer registries across Europe within the ERA-net framework of combined funding and exchange in biomedical research, also needed because 'Europe against Cancer' funding by DG Sanco had virtually stopped by 2003. Much variation and even diversity was expected and best practices especially to be found in countries with a long tradition of cancer charities, cancer registration, organized mass screening and biobanking and where Program owners and researchers were increasingly listening to patient groups.

All in all and focusing after the first period the objectives of the project boiled down to:
- describing and comparing strategies, policies and practices in the operation, management and funding of European cancer registries including the research being done or being participated in
- providing recommendations for best practices in research development, ethical arrangements also related to evaluation of mass screening and biobanking as well as in career development
- disseminating and transmitting that knowledge widely at regional and national and international level
- provide programme owners with a statute for governance in the rapidly changing world of cancer surveillance based on existing and developing population-based and clinical databases
- improving the quality, comparability and availability of cancer incidence data across the EU (regionally and nationally) thus providing regular and timely information on the burden of cancer across the EU
- capitalizing on well-tried functions of cancer registries e.g. contributing to health-care policy and planning, by practice based cancer research and cancer surveillance
- promote the European dimension of cancer epidemiology and prevention
- promoting participation of the network of European cancer registries in the ERA-net formula of cancer research, thus connecting registry-based researchers with research funders
- also involving cancer surveillance in the 10 new member states (since 2004 and especially since 2007)

It was known that the rather unique but vulnerable networks and data infrastructure of population-based cancer registries, especially their scientific - mostly epidemiologic - staff needed strengthening through taking barriers away for a more intensive use of the basic data if enriched by clinical, pathological and screening data. But they are often hampered by rather varying interpretation of national rules for data protection, in some member states more than others, despite the 1995 EU-directive. Assuming that no data definitely obscures any transparency, exploring conditions for extending coverage of cancer registries, being less than 50% of Europe at the start of EUROCOURSE, became an objective, albeit remaining a national competence. This implies that there are no valid data on risk and prognosis of cancer of about 1.7 million newly diagnosed cancer patients and of 8-10 million patients ever diagnosed with cancer. As comparability of cancer information - in time and place- is a raison d'être of special - autonomous - cancer registries, often also big clinical and commercial interests being at stake, grasping the precise nature of input and output of registry processes became another purpose (as in a certification process). The objective of exploration of its costs (per case, per inhabitant) can be expected to carry widely varying results in the various member states not only according to gross domestic product, but also derived from tradition based regimes of managing Public Health, cancer surveillance, payment and quality assessment of clinical care. But, interestingly, under all circumstances with an increasing role for cancer registries and clinical registries, to monitor variation and impact of change.

Living in 2013, formulating objectives in 2007 does not necessarily imply control of dramatically changing circumstances. Devised in 2007, EUROCOURSE started in 2009 after a long negotiation process that was also affected by important mission and management changes at the International Agency for Research of Cancer (IARC) in Lyon. IARC was one of the key original partners in the project as longstanding host to the secretariat and databases of the European Network of Cancer Registries (ENCR), but became an important subcontractor for Workpackages 1,4,8,9. Its position further diminished when DG Sanco announced in 2011 that the EU Joint Research Centre in Ispra was going to play a bigger role in European Cancer Surveillance, changing the future orientation. Moreover, the financial crisis, Euro related or not, impacted heavily on public finance and fund raising, likely affecting certain member states more than others, but anyhow also co-inciding with marked changes in demography (more cancer in ageing populations) and in oncologic practices (centralization of complex surgery, introduction of molecular medicine and expanding mass screening campaigns e.g. for colorectal cancer, but all demanding to be evaluated). Thus a stronger role emerged for cancer registries, if available and indeed so much that clinical cancer registries - population-based or not - were also on the rise and because the interaction with them was already in the DoW, this aspect got more attention, also at the Summit in November 2011. During the last 5 years, the increasing tendency to pay systematic attention to all aspects of survivorship a.o. through patient reported outcomes, has been paying off already in - again widely differential - more research funding here and there, requiring further attention.

So, whereas EUROCOURSE had a harmonizing objective, the reality of aforementioned marked and interesting developments in oncology in the various member states not necessarily complied with the wide range of national efforts if not priorities. So we should not be surprised to find more challenges and diversity through European comparative studies, also of funding research.

Project Context and Objectives:

EUROCOURSE meant to address the opportunities, requirements, basic and advanced functions of population-based cancer registries. EUROCOURSE also explored the strengths and best practices of the registries for all beneficiaries (patients and doctors), stakeholders and the cancer research community (ERA-net). The main purpose was a basis for a sustainable development and better use of cancer registries across Europe, to control cancer epidemics better and improve quality of oncological care through research of practice.

EUROCOURSE Work Packages
The EUROCOURSE Work Packages (WP) 1-4 had a more general nature, and focused on conditions for further development of and synergy between cancer registries across Europe, promoting timeliness, comparability and cooperation by pooling (for rare cancers) or comparative studies of risk and prognosis, thus a stronger and more dynamic and sustainable ENCR less hampered by divergent applied ethics in the domain of privacy, and strengthened by better working methods and - ever changing- classifications, guaranteed data integrity attaining high external validity and if possible wider coverage. (again: no data no transparency)

As simple as this may sound, the complexity can be illustrated by the fact that there 100-150 types of cancer (if not more) often ordered in 10-15 major categories (tracts) and involved medical specialties; then, based on favorable experience of the coordinator the research supported or conducted by cancer registries could be ordered in 5 research domains (also present in ERA-net) in which there about 5 research domains can be distinguished:
- public health and prevention and of organized mass screening (wp 5),
- quality of care (process and medical outcome) and aspects of cost-effectiveness (wp 6),
- survivorship and Quality of life (wp 6)
- prognosis as determined by tumor biology and host genetics and immunology (wp 6,7)
Other interpretations are possible like of childhood cancer or cancer in very elderly or rare cancers but in fact it can pertain to any tumor.

We have then developed (in wp1) a model (by means of an excel file) in which a cancer registry can describe the processes of input, throughput and output and thus exhibit its performance and potential to any interested Program Owner(s). In trying to communicate with Program Owners in the various member states e.g. in preparing the summit we discovered often a high level of disengagement and a lack of curiosity which explains probably also the passive and too administrative nature of quite a few registries in which there is also little personal development.

In fact a selection of more dedicated registries visited most workshops and an optimistic picture of the potential, because data cemeteries don't contribute much as appeared from a selection of those visiting the workshops.

So, the 'registree' was also developed as metafore, following the project logo and symbolizing also indeed the local roots and global fruits and aimed to make our environment understand how unique and also vulnerable the various networks are without the right governance.

After 2 years of wrestling with the question who is responsible for what and being persuaded from the tremendous potential of cancer registries for cancer surveillance and cancer research and having seen how many registries were languishing or even dying in case of abrupt changes by insensitive Program Owners in certain MS it was decided in a working group to develop a Governance code for Program Owners reflecting their important duties. It has been in discussion since the summer of 2011 and can now be offered (in fact it should be translated in the languages of the MS, because of the local interest and the limited EU- authority.

Specific applications by means of recommendations were developed for the PBCR's and all their users/clients/data providers, i.e. concerning
- ethical rule setting (wp 2) finalized in 2011, which needed specific additions for the clinical registries and biobanking and tissue repositories in 2012, which contain much more potentially identifiable information
- and an additional critical assessment was made during 2012 by WP2 of the emerging EU regulation and lately the potentially damaging LIBE committee comments. (ongoing process in 2013 ) with great support from subcontractor Medlaw Consult)
- recommendations for improving data quality, coverage, completeness, timeliness (Wp3), specific advices for classification of haematologic malignancies and for registries of childhood cancer, all done in small committees
- essential and direct evaluation of mass screening (limiting inherent over- and under detection) (Wp5) in agreement with European networks of cancer screening ,
- biobanking (wp 7): recommendations for standardization the process of linking biobanks with cancer registries; this work had clear connections with other European projects .
- wp 4: provided a reflection of opinions of a group of users regarding extra items to be collected for clinical, etiological purposes

The following major activities took further place:
- development of an extensive questionnaire (WP 1 but with contributions of subcontractor that contributed with existing registry questionnaire, the Eurochip group having a similar but more limited task and all WP-leaders in order to base their work on the results (becoming available only during 2011)) which not only contained questions on funding and costs , of staffing but also questions relevant for each of the work packages were put in. This extensive questionnaire of more than a 100 questions was initially filled in through a special portal by 50% of the active registries and later by another 15%. In the end phase of the project extensive data analysis took place, preceded by a publication of the Eurochip group of certain aspects of in which they were interested (ongoing) all in excellent collaboration.
- bringing together good practices, publications, articles, etc WP 1 and 8 al put on the website
- wp 4: most energy was spent on realizing together with and at subcontractor IARC a portal for continuous submission of data of all (to be) recognized (in Cancer Incidence in 5 Continents) cancer registries: this work took almost 3 years to finish being ready in September 2012

Population-based evaluation of clinical oncological care (also including the rather large proportion of older patients, 60% being often older than 65 years) increasingly interacted with newly developing clinical databases (sometimes called audits) and - also increasing - interaction with biobanks containing molecular or genomic diagnoses to be used for personalized care and to be validated in translational research. The coordinating WP's 8 and 9 focused on dissemination and training, with special attention for the new member states in the southeast where gaps in surveillance and access to adequate oncological care tended to widen (if to be described at all). At the European Cancer Control Summit in November 2011 progress was shown of the insight in widely varying activities, stakeholders and program owners which took the floor to comment, also including patient group representatives. All expect registries to monitor trends of cancer burden, follow-up of cancer patients and to evaluate cancer control. In these roles, the coverage of cancer registries needs to be enlarged in large member states (WP1), and need more support especially in the South-East and Mediterranean (SEEM) countries (WP8). The identification of best practices showed that cancer registries in Europe are united in diversity. There is much heterogeneity in funding (WP1, 3), usage (WP1, 2, 4, 6, 7, 8, 9), legislation (WP2) and data protection (WP2). Some registries only collect the basic data set, while others have extended possibilities (WP1, visualized in the cancer 'RegisTree'). Unity is in standardized data collection (WP3, 4) and basic training of epidemiologists (WP1, 8). Data collection depends on funding, but also on agenda setting and anticipate on future developments (WP9). For European cancer registries the ENCR is the platform for 1. collaboration, exchange of data, best practices and recommendations and 2. training of cancer registry data managers and epidemiologists.

Project Results:

Content
1. The value of cancer registries
2. The statute of EUROCOURSE conclusions
3. Taking responsibility for cancer patients
4. Some more specific results
5. Conclusions and foreground of most important outcomes
6. Future actions

1. The value of cancer registries
Underlying motive for the EUROCOURSE ERA-net project was the absolute need for strengthening the essential collaborative comparative research function of the 175 or more European Cancer Registries first and foremost with regard to variation in risk, prognosis and the burden of cancer across the EU (about 3.5 million of new cases in 2012 and about 1,75 million 20 million being alive with a diagnosis of cancer ever, of whom almost 1.8 million die annually - about 33% or 600,000 within a year of their diagnosis - and most of the other 1,200,000 having been in palliative care for months to years and/or being terminally ill for weeks to months). But equally pivotal is its essential role in the evaluation of organized mass screening i.e. consisting of linkages to registries of screenees in order to assess effectiveness and attenuate potential harmful side effects of over diagnosis and interval carcinomas (mostly missed diagnoses occurring between screening rounds); other linkages to cohorts of irradiated or UV-exposed people or working people being studied for carcinogenic effects of occupation (e.g. Nocca study in Nordic countries) and of diet and cancer (the EPIC study in 10 countries) and many other cohorts and biobanks and other data repositories in Europe, of course only there where cancer registries are, i.e. in about 50%. Increasingly, adequacy of oncological care (contributing to transparency) is being studied in about 20 to 25% of the European population where stage has been recorded, and just survival in about 50%. Studies of quality of care and prognosis of patients with rare malignancies and of very old patients with cancer would not be easily possible without cancer registries.

2. The statute of EUROCOURSE conclusions
1. if population-based cancer registries would not exist, they would have to be invented both for public health, quality of care and cancer surveillance and research purposes in fact minimally describing change and its potential impact on quality of life
2. every European citizen and every oncologic care providing physician should be covered or served by a cancer registry offering regular feedback (which is of course in the domain of responsibility of each of the EU memberstates): its absence should be considered as a risk factor and precludes organized mass screening
3. without changes in the epidemiology of cancer and in cancer management and without practice based cancer research a cancer registry would not have much value
4. informed consent of patients does not lead to adequate, complete cancer registries with comparable datasets and based on current practices of data protection whereby the researcher cannot trace the identity of the patient but new data can be added on request by the attending physician (also called pseudonymisation). Population-based cancer registries have proved to be 'absolutely' safe in the domain of data protection, whether with a legal basis or derived from organized professional self regulation
5. if cancer registries should be more visible in the world of oncology, oncopolicy and media it is rather through their front office.
6. cancer registries are a blend of a simple population-based epidemiologic methodology applied in - the context of - any system of organized medical-specialized oncological care and thus offer a picture of 'unity in diversity.

3. Responsibility for cancer patients
The EUROCOURSE project dealt with many technical and logistical aspects, to be considered as standardization of processes to improve comparability, timeliness and coverage, and provided tens of advices and a few formal recommendations. They are primarily aimed at a professional multi-disciplinary oncological audience, consisting of thousands of dedicated cancer registry workers in the back-office (on average one per hospital) and fewer in the front office (although there is a golden rule of spending 50% of the energy on data collection and 50% on - preparing - intelligent reporting). They are embedded in hundreds of thousands oncologic workers with all (about 10-20 major) their clinical and professional networks who ultimately work for almost 20 million (ex ) patients with ever a diagnosis of cancer, of course mostly for the 3.5 million of new patients who receive this message every year (as of 2012) and the about 1.8 million dying. Thus – the work should be disseminated properly through the available networks from the European Network of Cancer Registries (ENCR) to the European Cancer Care Organization (ECCO).

One could then reckon with:
- 100-150 distinct entities divided over 10-15 tracts, and specialties (head and neck, lung, skin, breast and female genital, prostate and male genital, uropoietic, haematological, endocrine, Upper GI, hepatobiliary and colorectal, CNS, bone and soft tissue, sarcoma, childhood.)
- 5 major research domains, each with a basic and advanced variant and with one or more study questions always concerning variation in time and place
this might lead to from 50-100 at aggregated level (tract) to 500-1000 very (=site or histology or age) specific research questions, inevitably leading to sharing of data for the whole range of research activities, but often there will be clinical initiatives that can be joined and supported by dedicated cancer registries.

This leads to a few conclusions:
a. specialization of personnel in the cancer registry is more and more needed, certainly in the front office but with growing complexity also in the back-office;
b. an increasing necessity of seeking scale leading to larger registries (see also WP 3) but either or not through networks of population-based and clinical databases where - of course anonymous - data can be shared and expertise mobilized which in fact is already a growing practice.
c. although regularly suggested and appearing logical: coalitions with the worlds of surveillance of other chronic diseases: the complexity and multitude of cancer makes that such coalitions run the risk of weakening of what should become stronger. Thus they should only be encouraged for specific clinical/epidemiological reasons, thus based on study questions (what are specific problems of diabetes patients who get cancer and what would help? do diabetes patients indeed get more/less cancer and why?) Anyhow, we should resist the temptation of siren sounds of efficiency to bring all the chronic disease together in one information system. It will certainly hamper comparability also at European level.

4. Some more specific results
1. Costs of data collection proved to be rather variable, from about 25 to 75 EUROS per new case, but being dependent on locoregional-national organization of registration efforts within specialized care in general and oncological care in particular, which is also affected by the various options for linkage with pathological laboratories and clinical databases. (wp1,3)

2. Coverage: Currently, population based cancer registries (PBCRs) serve about 50% of the EU population, only about 25-35% in the bigger countries but 100% in the UK where the Cancer Czar aims at national control; similar tendencies but at smaller scale exist in the Nordic countries (each with 5 million, Sweden 9), Holland, Belgium and Germany, decentralized at state level (Nordrhein Westfalen having as many inhabitants as the Netherlands) and 75 clinical registries being planned. As long as there is no coverage by a cancer registry, mass screening is not well possible taking the interest of screenees seriously. Thus, mass screening cannot be properly evaluated in large parts of Europe. Ways and means were explored and priorities given to expand coverage of cancer registries and make them report faster, especially relevant in the domain of clinical care evaluation. Here, PBCR's have a unique role for studies of cancer care in the elderly and of impact of regionalization.

3. Clinical registries (WP6): Rapid developments in clinical tumor-specific registries (CTR) have been described, their status still evolving in most member states, being often not population-based and being fed by - often web-based and potentially insecure - data input from practicing surgical oncologists (also gynecologists, head and neck surgeons and urologists), often interested in surgical outcome. Ultimately, as shown in WP 6, PBCR's and CTR's share benchmarking aims by recording more extensive clinical data (PBCR's more inclined to work with minimal data and catch all patients, CTR's rather embarking on 'greedy' data collections not necessarily submitted on all patients and neither by qualified data managers, albeit being part of ethics of this type of research), but both engaged in providing (regional or national) feed back to involve the care providers; leading to - sometimes confusing due to incomparability- transparency by exhibiting variation in time and place of patterns of care, often interested in new treatments. Generally, radiotherapy also records its own activities for up to 45% of all new patients for many decades, but most data collections are not population-based thus of limited external value; referral patterns are only to be explored through PBCR's. Explorations need to continue in this area because the aforementioned problems do not go away automatically and patients might start protesting that they are in too many databases without understanding the purpose any more. And of course there are problems with methodology, including data integrity and safety and threatening fragmentation of the cancer registry landscape, clinical registries not necessarily starting in areas without a PBCR.

4. Funding by research domain: In WP 1 special efforts were made to explore the widely varying patterns of funding by a.o. cancer societies, buyers of oncology services or governmental agencies, partly also through funding of public health, clinical and translational research. Incomparability reigned. This became more clear when the (four to six) overlapping research domains around the PBCR were identified with their specific initiators, study questions, research methods and involved disciplines and with varying timelines of data collection and dissemination: public health and prevention (etiology and mass screening), quality of care (process and outcome and cost-effectiveness), survivorship and quality of life and prognostics (tumor biology - increasingly stored at biobanks - and host features like co-morbidity and socio-economic status).

5. Conclusions and foreground from the overview of the most important work on the project:
WP 1 in search of the registries, Program Owners and research funders
- Development, testing and analysis of a large questionnaire on functioning, costs of collection and research, staffing of cancer registries within the EU: in electronic form available, adaptable and repeatable , good test for any new registry
- Detailed analysis of anatomy and physiology of the cancer registry: to be filled in by every registry for itself and for its program owner: to be used for long term planning
- input, throughput and output of cancer registries illustrated by a 'RegisTree' (as
symbol): from root to fruit: to be used (and adapted) as metafore and make the outside world understand what a registry is like
- research programming in 5 domains: extremely useful classification for any audit of a registry and also for ERA net
- A document on Governance, '10 commandments for Program Owners': to be translated in all the EU-languages and use it to make the Program Owners aware of their responsibilities (a living document to be refined in the near future)

WP 2 : Ethical considerations: extremely actual in relation to looming EU regulation on data protection
- New ENCR guidelines on data protection, including use of trusted third parties (2011) underpinned by an extensive report of subcontractor Medlaw: the first just to be implemented and the second to be used in discussion on follow up
- A commentary on a proposed draft EU regulation (2012) : overtaken by Libe comments
- Extra comment on Libe advice (early 2013): extremely important that EUROCOURSE is heard

WP 3-4 Better organization of the Back Office: all very useful for program owners and program managers
- Economic analysis of a sample of 20 cancer registries: for strategic discussions on future funding (NB a national responsibility)
- Recommendations for coverage, completeness, death certificates, timeliness etc: agreements with registries: can all be implemented through ENCR and JRC Ispra
- Recommendations on classification of Hematological Malignancies and special registries of childhood cancer
- European Cancer Observatory (ECO) website for accessing and downloading cancer statistics (see http://eco.iarc.fr online)
- Portal for data and questionnaire submission (see http://cinportal.iarc.fr/cin online)
- Preferences of users of CR data (working group)

WP 5 Role of registry in evaluation or organized mass screening
- Guidelines on linking screenee registries with cancer registries: extremely useful also to make cancer registry Program Owner co-responsible for immediate evaluation of mass screening; representatives of (potential) screenees should speak out for timely evaluation; data protection regulation could wreck this

WP 6 Clinical evaluation and interaction with clinical registries: offers scope on new developments as they are practiced in more and more registries: good practices to be followed especially for participation in Era net Horizon 2020
- Priorities and new modalities of cancer registries for population-based clinical research, focusing on
- geriatric oncology: recommendations on extra items to be collected
- survivorship: patient reported outcomes: overview of literature + recommendations
- utilization of specific costly therapies
- effects of regionalization
- Scope for cancer registries to collaborate with rapidly increasing specific clinical registries and vv : methodology and overlap: surgical, pharmaco-epidemiological (European inventory): inventory to be actualized and more details on potential overlap and methodology; a potentially exciting development could ''end in tears' for both the population-based and clinical registries on a variety of grounds (methodology, data integrity, safety and protection, confusing overlap, competition in funding, fragmentation of the registry landscape (''wood becoming invisible by the trees'')
- Recommendation on local recurrence (or other indicators of progression): only with study question and audit wise: important overview for all those interested in clinical evaluation of quality of care
- overview of European comparative studies on outcome: how to proceed? Worthwhile conclusions will help to avoid pitfalls, delays in (many currently light-heartedly planned) outcome studies without adequate study motives and questions: important for ERA-net and Horizon 2020;

WP 7 Linkage to biobanks:
- Guidelines for linkage of cancer registries to biobanks: very useful for translational cancer (clinical) epidemiology and clinical research, (ERA-net etc) if indeed biobanking becomes widespread; now already a stimulus for secondary use of tissue at pathology, provided EU regulation on Data protection will not block this

WP 8 Dissemination with extra attention to cancer registries in New member states
(- Development of an advanced cancer registration course: to be picked up by any academic postgraduate medical institution that wants to provide such courses
- Initiate and develop Collaborative group of cancer registries in South-East European and Mediterranean countries (SEEM): will benefit enormously from EU-reg database to be supported through ENCR secretariat and JRC Ispra: EU cohesion funds need for staffing
- Development of Draft statutes of a European Society of Cancer Epidemiology and Prevention (ESCEP): to be picked up by Cancer epidemiologic community , then ECCO staff and to start in 2014 (business plan needed)
- EUROCOURSE reporting in special issue of the Eur J cancer: to appear in autumn 2013: (in preparation by WP-leaders)

WP 9 Summit and future plans: should probably be repeated within half a year from now because conclusions and concrete steps can now be made
- The EUROCOURSE Summit with our European stakeholders showed there is need for:
- more involvement of patients and clinical groups and improved governance: an improved Front office
- more accent on visibility and communication of cancer registries (in fact a better front-office): strengthening of research and communication staffing, social media, research domain programming + career development, academic affiliation of staff : essential for participation in Era-net etc
- A Calendar of 25 years of ENCR: Cancer registries in Europe + plans for the future: 1988-2012-2020 (comprises 24 posters): historical perspective useful ; challenge for EU JRC Ispra to make the future of ENCR a success
- Exploring the potential of a supporting Foundation for ENCR: European Organization of Cancer Registries: still needed to work out further; in fact no task of EUROCOURSE, now up to JRC Ispra and SC of ENCR

6. Future actions

Although the methodology remains simple the Cancer Registries appeared more complex than expected beforehand, being multi-dimensional, heterogeneous and therefore vulnerable, also by the clinical registries. There is need for a reinforced infrastructure and approach for a solid and stable basis and financing of cancer registries. Therefore best practices in registry organization and research output have been identified and involvement of stakeholders has increased.

The EUROCOURSE project advises: Improved communication within the ERA-net, in particular:
By the members of the ENCR:
- Inform data users: the former use of data by IARC kept cancer registries invisible. EUROCOURSE started with the European Cancer Observatory (ECO), that can be used for communication and uses information that has been and will be collected in former and future data calls (WP3/4).
- Inform and involve stakeholders: Cancer registry data managers and program managers may visualise their stakeholders, using the 'Cancer RegisTree' and it's accompanying scheme (WP1). The 'RegisTree' can also be used to create understanding of the registry process and create future perspectives for the registries. The cancer registry Program Owners (PO) have to be informed about the indispensable value of registries and also have to be reminded about their responsibilities for cancer registries in cancer control through the '10 commandments' (WP1).
- With the research community: epidemiologists and health-scientists. Because of the diverse and increasing number of cancer registry staff (data managers, programme managers, epidemiologists) in Europe, there is continuous need for education and dissemination of standards and best practices to professionals at all levels. EUROCOURSE and the European Network of Cancer Registries (ENCR) have and will additionally disseminate the EUROCOURSE outcomes. These outcomes have also been summarized in an advance cancer registration course (WP8), that should in the future be organized by the Joint Research Centre (JRC). Also an exchange program has been proposed (WP8).

The EUROCOURSE project advises: Better governance of registries.
EUROCOURSE started to clarify who the cancer registry stakeholders are, on the regional/national level, but also at the European level (WP1/9). Most cancer registries languish by lack of continuity and long term perspective. Their POs are often not aware of their responsibilities, ignore the registries and are guilty of arbitrary policymaking. It allows for an unduly, potentially abusive freedom to act with one sided interest and challenges often dictate. Therefore within EUROCOURSE the '10 commandments for good governance' have been written by 10-15 participating POs (WP1). It tries to define the identity and mission of POs and explores their responsibilities as perceived. The document more or less strives at the ideal scenario for Governance of a cancer registry, engaged in more than one research domains of cancer surveillance. The document has to be circulated among the most important stakeholders of cancer registries in all European countries. It is moreover an excellent best practice guideline for new POs and their operational counterparts, the Program Managers (PMs)

The EUROCOURSE project advises: Expanding funding perspectives by increasing visibility.

EUROCOURSE initiated to find out the budgetary aspects of registries, showing that there is very much variation in sharing of costs (WP1/3). But funding perspectives emerge particularly from insight in who the POs are and the research programmes for which cancer registry data can be used. Cancer registries can be involved in many types of observational research and of course for each tumor type or tract and therefore they are much cheaper than clinical studies. EUROCOURSE proposed a 4 domains research infrastructure of Public Health (etiology and mass screening), Quality of Care (process and outcome, cost-effectiveness), Quality of Life (long term toxicity and side-effects) and Prognosis (biological and host features) (WP1). In theory, there could thus be four times as many research programmes as the number of tumor types. Regardless whether a registry is basic or advanced, they are able to perform studies in all 4 domains. The studies and therefore output of a registry depends on the phase of development of the registry (which can also be visualized using the 'RegisTree'), but also shows that there are many types of cancer registries. Most registries are active in two, but increasingly in more of the research domains. It depends on the specialization of the registry, it's focus, and the (financial) involvement of stakeholders, who also determine the behavior of the POs and PMs. New research (and funding) possibilities also arise when collaborating with screening organizations (WP5), clinical databases (WP6) and biobanks (WP7).

Cancer registries currently facilitate or conduct a large variety of studies of a large variety of patient groups whose outcome is monitored at short- and long-term. Reasoning in extremo, one could discern up to a 1000 different studies or articles in progress. It is therefore not surprising that the annual production of articles conceived and written by the cancer registry staffs and engaged stakeholders within the various member states of the EU is more than 500 and another 500 papers just use the data (in national reports etc.). So, visibility and invisibility of cancer registries go hand in hand. External visibility for the registries of overview papers, especially from Globocan and Eurocan, completely lags behind by the abundant naming of co-authors of genetic consortia and collaborative groups like EPIC. We should change that by following that pattern

Potential Impact:

General statements
EUROCOURSE has indirectly shed light on clearly necessary conditions affecting population-based cancer registries, being vulnerable network organizations legally, operationally and financially.

1. Firstly, by sketching unequivocal privacy codes or guidelines allowing for an informed 'opt-out' of patients.
2. Secondly, taking the currently wide international variation (politically and oncological and health care determined) into account, it will also exhibit the potential ideal mix of stakeholders, including cancer societies, public health institutes, health insurance companies, regional or national governments, increasingly influenced by patient groups, who act as program owners. Of major importance is that the initiative in WP 1 to develop these 10 Commandments for Governance by program owners, often not having the slightest idea what they are supervising or paying for, let alone commissioning; if invited most of tem were not interested in the project (were probably never informed beforehand); This document is likely to be published in the new Journal of Cancer policy and a short summary in the Eur J Cancer to get a wide distribution.
3. Thirdly, by sketching for program managers the requirements for training and career development of relevant health scientists who then are better able to collaborate optimally with oncologists with their continuously changing diagnostic and therapeutic practices, and being in contact with them regularly will then feel at home in the ERA-net.

The EUROCOURSE ERA-net project aimed to strengthen the coverage, research and output generating capacity and thus visibility of those in the front offices of the 175+ population-based cancer registries in the various member states of the EU, united in the European Network of Cancer Registries (ENCR) currently residing at the International Agency for Research of Cancer (IARC) in Lyon and the EU Joint Research Center (JRC) in Ispra (It). The registries only cover 50% -55% of the European populations and about 25% with stage at diagnosis, in fact often the tumor size as an indicator of access and prognosis. At member state level the registries are financed often with money coming from tax- or premium payers and/or cancer research supporting donors or sponsors, somehow supervised by a variety of program owners like Cancer leagues, provincial and national Ministries of Health, Health Insurance Companies, Comprehensive Cancer Centres, Institutes of Public Health and Universities with different objectives and priorities for cancer control and dependent on health political, professional and oncological professionals, researchers, public health and cancer patient voices often represented by cancer charities. Their domain of fund raising is also in a flux, in fact towards more money needed to be spent on patient-related research and awareness promoting activities, whereby more and more fundamental laboratory research is considered as a task of government. Observational research of quality of care and risk and prognosis remains very dependent on priorities which does not make it easy to predict what the priorities will be. So future impact will be determined strongly by optimizing the research in the research domains identified during EUROCOURSE which builds upon best research practices of recent years: public health and prevention, public health and mass screening evaluation, quality of care and outcome research. Also contributing to cost-effectiveness, survivorship and quality of life, prognostic research including biology and of the tumour and host characteristics like co-morbidity, also including genomics when available in biobanks linkable to the cancer registry. Registries will be used more when there are more cohorts of screened, examined for exposures related to life style, socio-economic status or blood donors. These cohorts are often started by academic institutes but also by pharmaco-epidemiologic service institutes.

It is clear that adequate ethical interpretation of data protection regulation and procedures for using personal identification numbers and pseudonymisation are essential for rapid and safe responses to crucial research questions, whereby the Nordic countries clearly show the tremendous possibilities of linkages to and with the cancer registry. Their assessment of the during the reporting phase ever changing proposals for a new data protection regulation are crucial, also because until now no wrongdoing or violations of data protection have ever come to light in the last decades. Of course, the program managers of cancer registries and ethical committees bear responsibilities here and increasingly there is supervision by patient groups. All in all, although the situation is far from ideal in some member states, good and productive practices of data protection are abundantly present, but also bad and costly ones, also especially in Germany. It is up to the program owners and ethical committees to follow the best practices and defend these in their country, thereby following the recommendations on data protection developed in Wp2, and also relevant in recommendations on evaluation of mass screening and linking to biobanks.

Registries do well to anticipate on participation in research programs related to all sorts of cohorts available in their catchment area and can thus adapt to all sorts of medical and societal research priorities. Like there is now priority on assessment of quality of care, including late effects of treatment, prevention, side effect aspects and consequences of overtreatment in survivors, inequality and translational research. Often there isspecial emphasis on cancer in children and adolescents or in the very elderly. But while good practices are clearly available it seemed very much to vary by member state and the learning capacity seems clearly insufficient at a European scale, thus it is not easy if not impossible to develop a consistent view on the future of cancer research and its funding as if ERA-net and Horizon 2020 were already in place.

Compared to the American Surveillance Epidemiology End Results Program (SEER) covering now 28% of the US population, largely funded by the National Cancer Institute and CDC, funding of European health information programs by DG Sanco and cancer registry-based research by DG Research and Innovation is a fraction, nevertheless with a relatively large output in the various research domains increasingly also in continental and southern Europe, the Eurocare project being exemplary (see a.o. WP 6), but still suffering from all sorts of delays, e.g. Eurocare always being 7-12 years behind after the diagnosis. Unfortunately, the common data portal developed in Workpackage 4 was not yet ready at the start of Eurocare 5 but certainly is there for Eurocare 6, covering the diagnostic period 2008-2012. Of course things are more complex, about 10% of the patients getting a second and a third cancer and such patients only die once. At first sight, our population-based methodology of the cohort study is simple although the cohorts are rooted and financed in the member states, and it largely comes down to initiatives for pooling of data e.g. for studies of uncommon cancers and/or providing frameworks for comparative studies of variation in time and place of risk and prognosis according to relevant determinants, sometimes including socio-economic status or the BNP of a member state. A better match of both the national and European, very modest indeed compared to the USA, funding sources seems urgent and a road map for that can be prepared based on what we know now from the large questionnaire in WP 1 and the cost study in Wp3. Nevertheless the financial problems with public finance in the various member states are such that efforts to use cohesion funds for developing data infrastructure might be a great step forward. Let us realize that the monitoring system for cancer control in Europe remains as insufficient as the weakest link but and within countries. When there are no data at all, the population and the patients should be supposed to be in danger unless proven otherwise.

One is or should therefore always be anxious to see more adequate cancer control realised in the various member states of a more active cancer registration system (for the other 50%) across the EU. It is clear that the observed variation in cancer mortality, sometimes described as gaps, shows great potential for improvement i.e. smaller gaps in 10-20 years to come. If one sees how heated the debates become when there are data on incidence trends or access to care, when there are such data, often in need of becoming better and faster, and even if certain discussions are exaggerated by professionals and media, the awareness rises for all sorts of improvements , changes etc. Ignorance and silence in cancer control maybe as dangerous as cancer itself!

Now let us use our imagination: In order to lower or to equalize cancer mortality (one of the major objectives of cancer control or any National Cancer Plan population-based cancer registries can be involved in monitoring (recent ) trends in incidence and survival but can also predict such trends based on scenario analyses. The question is whether as a result of EUROCOURSE such trends will become more favourable than without more and better cancer registries with better staff, especially in member states with problematic coverage or staffing anyway limited output level, will have a stronger future impact (a lag time 5-15 years seems reasonable if not longer) on avoidable cancer mortality in many if not all member states while also trying to sustain a reasonable quality of life, the former through favourable influences on cancer incidence and survival either by promoting more rapid implementation of prevention and /or improving cancer survival through quicker studies on variation of quality of care, the latter by facilitating studies among cancer survivors such as carried out now and as a consequence changing primary adjuvant treatments or performing interventions. In principle the answer is yes, when indeed a reactive way of thinking on prevention made place for pro-active scenario-driven thinking and modelling as advocated in another registry-based FP6 project (Eurocadet) on Scenarios for Cancer prevention http://www.eurocadet.org with the Prevent model being fed with as recent as possible and reliable age-specific incidence trend data of any avoidable cancer and reliable - older please - data on relevant exposures were available from or within that member state on e.g. trends in smoking, alcohol, obesity, physical exercise, UV irradiation (at young and middle age) etc. in the 1980's to 2005 or so or have to be simulated. And when for these or other cancer(s) preferably comparative studies could be performed of variation in certain patterns of effective care (whether called high resolution studies or just outcome research) which would raise discussion on adherence to textbook knowledge or recent guidelines (always needing adaptations especially for the elderly and those with co-morbidity) also showing superfluous or ineffective practices (indeed another good reason to have clinical population-based cancer registration everywhere, it may pay itself even back) in order to diminish loss of quality of life, e.g. neuropathy or fatigue or swollen legs or arms from certain adjuvant treatments with a high Number Needed to Treat (NNT) ratio to avoid one recurrence or death but accompanied by the ratio of the Surviving proportion Harmed by that treatment. Such studies could of course be done more easily in countries with good data such as in the Nordic countries and the Netherlands and UK where thanks to monitoring initiatives of decades ago nowadays studies of early adverse reactions on unfavourable changes has become a crucial part of the oncological and public health culture, it will really help if such studies were carried out , imperfect as they are, in more and more other member states, the more the better, paradoxically most needed where there are the least data (being sunrays in the dark) available or only in parts of the country in the bigger member states like Romania or Poland or Italy or Spain or even Germany (where they are now planning to have 75 new clinical cancer registries (where do all the intelligent epidemiologists come from and how are they going to work together?).

But publishing such studies more rapidly than now, even if primarily based on member states with good data (because that is what we have and should be exemplary) may also help - based on studies of trends in incidence of head and neck and lung cancer in women, to raise or intensify political discussions on indeed raising taxes on alcohol or tobacco, promoting better diets, and more physical exercise (extending safe bicycling etc.) and there will be studies potentially affecting cancer survival and mortality promoting application of effective treatments, possibly also in older patients. Does one have to be a bigger optimist to believe in these mechanisms than in new - very costly - targeted treatments (that no patient would wish to miss even if the chance of being helped is very small) or is it just a better strategy to do both. In poorer member states cohesion funds might help top provide data infrastructure (= much more than just E-Health by the way, should also be building on existing data collection activities) for public health, taking oncology as a relatively developed, advanced area (also because of the standardising independent influence of pathology, combined with epidemiologic methods an unbeatable couple) with many good examples around in Europe. Good and persuading - population-based - examples get a following is perhaps the dogma here.

Is doing nothing an option or be so slow that we now know that the gaps in risks and mortality will remain for another 50 years? Isn't the enormous variation in incidence and survival of cancer in Europe a wonderful and compelling stimulus for investment in the order of 1 EURO per inhabitant per year which after 10 to 15 years is not only earning itself back, but also drastically improving quality of life and dragging along other investments also in infrastructure (for safe biking) which also happens to lead to more clean air in cities. The point here is of the European approach to make the usual gap between East and West and North and South smaller.

The above is also following the work in WP 8 of EUROCOURSE which was supposed (in 2007) to provide special attention to the new member states, many of those had reasonably good statistics still derived from the Vienna School of Medicine, in fact Pathology, which flourished in the Habsburg era and also under Communism ending about 100 and 25 years ago, respectively and showing the enduring strength of good traditions. But the times have really changed. After the large and intensive workshop in Iasi in Romania in May 2011 it was encouraging to see how a few individuals from these member states together started publishing on cancer trends under rather suboptimal circumstances, also to become visible as was suggested/asked during the EUROCOURSE summit meeting (Wp 9) in November 2011. The impact of this work will only remain if it is followed by cohesion-like funding of personnel and data infrastructure with concrete help from experienced epidemiologists guiding a program of registry-based research activities and which then starts making the registries more clinical. Nowadays (too ) much money seems to go to targeted drugs and imaging which of course is also needed and E-health by itself is not enough, could even harm is existing data infrastructures are broken down such as happened in Slovakia (where the famous reliable cancer registry now seems to stop, starved of personnel).

Cancer is in that sense in the forefront not only just because of the suffering (the relative high cancer mortality at middle age is rightfully in the heads of many people, young grandparents becoming very important for the grand children) because of the longer tradition of availability of reliable data on incidence and survival (the latter reaching 45- 50% across the EU in 2007 according to latest Eurocare estimations), the cancer field also has the better statistics because now famous pathologists and radiotherapists and also epidemiologists and biostatisticians took all sorts of population-based initiatives 35 to 70 years ago. And fortunately we are seeing now many clinical and quality of care and quality of life measuring monitoring studies in the last 10 years (considered in workshops of WP 6) which can be exemplary and the dissemination of which falls in fertile soil, of a younger better trained generation of health scientists, data managers, IT specialists and oncologists who might be able to create a future for oncologic care and prevention of which the whole domain of surveillance of chronic diseases might benefit. Indeed, with the results of the EUROCOURSE project one could touch on broader quality of life issues for the 20 million (former) cancer patients alive than what translational medicine may be bringing for proportions of the almost 2 million desperate dying patients.

Conditions for a strong and active European Network of Cancer Registries.
EUROCOURSE is likely to have strengthened the European Network of about 175+ Cancer Registries (ENCR) and the discipline of cancer epidemiology, a.o. through the to be established - long awaited- European Society of Cancer Epidemiology and Prevention (ESCEP) that may also offer a platform of ideas and communication and may be a spokesman in the EU, also within ECCO and other clinical oncological groups. In 10 years time, it is likely that EUROCOURSE will thus have contributed to increase cancer registry coverage.

The ENCR data portal will most likely stimulate comparability by having reiterated the importance of various classifications, e.g. for haemato-oncology (notoriously difficult) if software updating will indeed take place and JRC Ispra will be likely helpful itself or will facilitate IARC to do this.

Within data calls for Horizon 2020, the vested study cohorts (like the EPIC study) will be increasingly interested to be linked to population-based cohorts of people for studies of risk factors or biomarkers and of mass screening. EUROCOURSE has established the data portal, which has been tested in a research-oriented professional environment (also for quality control). This will result in better conditions for European or global studies of determinants of incidence, detection and prognosis.

For sustainability, synergy and close collaboration between cancer registries is essential not necessarily always within ENCR, as long as there is hardly any secretarial womanpower available and while searches are taking place for. The EUROCOURSE Executive Board has advised in the transfer from IARC to JRC (WP10), and suggested a supporting Foundation for the European Organization of Cancer Registries (WP9) so that budgets might be acquired for e.g studies with the abundantly available by PhD students.

Besides, a procedure has been developed for the ENCR Steering Committee to react on disruptive problems in cancer registries by professionally not understandable, more or less erratic often caused by external circumstances not unusual in politics, behaviour of certain Program Owners (WP9). Within the project the ENCR has been visualised in the landscape of policy makers, scientists, health care professionals and patient groups (WP1) which may also have put it on the retina. It shows the many fold forces that are involved in cancer registration and its place in the cancer universe, but it also shows that the ENCR can be one of the spiders in the ERA-net of population-based cancer research. For the future of the ENCR, the (to be established) European Society of Cancer Epidemiology and Prevention (WP8) will therefore be important as a major stakeholder and beneficiary.

Bottom-line and after many discussions in the Executive and Steering Board: cancer registries should be more considered as a self-regulatory, professional program of clinical and epidemiological activities with add-on funding from the health care system than be a political instrument, part of power games between politicians and oncologic care providers and patient groups. Information is indeed power.

Politicians and patients should ask questions like why are we doing much better or worse than country x or y and have the right to get answers and be proposed certain studies to be funded through the existing.

The ENCR could improve communication on behalf of and within the ERA-net with a more active, paid, secretariat. They need to collaborate more intensive with patient organisations, who have most interest in transparency of cancer prevention, treatment and survival.

Some final statements and recommendations
1. The EUROCOURSE website http://www.eurocourse.org will remain online another year and will than probably transferred to the ENCR website, and will be referred to in future presentations and publications.

2. The executive board will inform the ERA-net about EUROCOURSE deliverables, products and follow-up of activities through newsletters and presentations at conferences.

3. Publications will
- Appear in a Special EUROCOURSE Issue of the European Journal of Cancer (autumn 2013) and get all the publicity from EJC and ECCO public relations
- Be written for several other journals like the Journal of Cancer Policy and relevant European oncology journals
- Be circulated within the ENCR and ERA-net and among other interested parties

3a. An important overview Publication of 'Population-based cancer registries for quality of life research: a work-in progress resource for survivorship studies?' by M. Thong, F. Mols, J.W. Coebergh and L.v.d.Poll-Franse will appear soon in the Special Issue of Cancer (Interdisciplinary International Journal of the American Cancer Society) entitled 'European-American Dialogues on Cancer Survivorship: Current Perspectives and Emerging Issues'.

4. The EUROCOURSE calendar with the 24 A3 posters has been distributed widely (February 2013) among all participants in all Member States among traceable cancer registry stakeholders (e.g. cancer society, ministries, oncological medical associations, patient organisations, insurance companies) and among those who attend the summit

5. Another Summit may be needed to reach further elaborated conclusions as the first one was still exploratory and that may be a good occasion for the start of European Society of Cancer Epidemiology and Prevention.

6. Strengthen collaboration of cancer registry stakeholders
Although the funding bodies of cancer registries vary for each member state (or region), they should work together in setting priorities for developing and implementing the capacity of cancer registries to improve cancer control. The Program Owners and Managers have been brought together in the EUROCOURSE Summit and awareness have been created about all the aspects covered in the project. Collaboration can be strengthened and parties could be guided in the right direction through the European Society of Cancer Epidemiology and Prevention (ESCEP).

7. Use dissemination possibilities through related networks, i.e.
- ECCO and E-cancer
- Screening and biobanking organisations
- Cross-linking with other European projects on Cancer
- Such as the recently started EU FP7 projects like PancareSurfup and EurocanPlatform, whereby this seems at this moment less relevant for Transcan because of the opaqueness of the financial situation of cancer registries
- Idem for European partnership against cancer (EPAAC) especially workpackage on cancer information and research funding (to see how that works)

8. Continuation of data collection and dissemination
European cancer registries have been provided by a renewed infrastructure for data input, throughput and output. Their visibility, particularly for stakeholders, will be increased by publications using the pooled data and mapping options. The European Cancer Observatory will also be used for gathering information for targeted communication, designing of and communicating on new studies and fund-raising for collaborative studies.

9. Continuation of the group of South-East European and Mediterranean countries (SEEM) will be stimulated

10. Activating cancer registries to use the '10 commandments' and the 'RegisTree' to make themselves visible, secure possibilities for funding and create future perspectives

List of Websites:

http://www.eurocourse.org

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