Periodic Reporting for period 2 - ADOPT BBMRI-ERIC (implementAtion anD OPeration of the gateway for healTh into BBMRI-ERIC)
Berichtszeitraum: 2017-04-01 bis 2019-03-31
"One of the challenges in the post-genomic era is researching common complex diseases, such as cancer, diabetes and Alzheimer’s disease. Conquering these diseases will depend critically on the study of human biological samples and data from large numbers of patients and healthy individuals. BBMRI-ERIC will provide gateway access for the European research community, expertise and services building on the outcome of ADOPT BBMRI-ERIC. The main deliverables were designed to launch and/or complete the construction of key Common Services of the Research Infrastructure as required for ESFRI projects ""under implementation"", reflecting the targets of the European Research Area (ERA). Through ADOPT, BBMRI-ERIC demonstrates the benefits of an operational distributed Research Infrastructure for high-quality research, innovation and international collaboration.
One specific goal of the ADOPT project was to gather 10,000 existing colorectal cancer (CRC) datasets. Technical and organizational measures to ensure data security and protect privacy of the persons contributing their data to the CRC-Cohort were discussed in-depth, and the agreement on data transfer was reached in compliance with the General Data Protection Regulation (GDPR), taking into consideration the differences in regulatory and ethical issues within the different European countries. A complex IT infrastructure was developed to support biobanks in delivering the data and harmonizing it to the central data model, importing and performing detailed quality checks on this data, the results of which were subsequently used by the biobanks to perform data updates."
One specific goal of the ADOPT project was to gather 10,000 existing colorectal cancer (CRC) datasets. Technical and organizational measures to ensure data security and protect privacy of the persons contributing their data to the CRC-Cohort were discussed in-depth, and the agreement on data transfer was reached in compliance with the General Data Protection Regulation (GDPR), taking into consideration the differences in regulatory and ethical issues within the different European countries. A complex IT infrastructure was developed to support biobanks in delivering the data and harmonizing it to the central data model, importing and performing detailed quality checks on this data, the results of which were subsequently used by the biobanks to perform data updates."
WP1: The coordination established effective links with all the WPs and supported the smooth and timely running of the project. The performance indicators were revised in 2017 and 2018 based on new input, ongoing discussions and experience. An amendment process was launched to extend the work around the creation of the CRC Cohort (WP2); the project was extended from 36 months to 42 months.
WP2: A CRC-Cohort of 10,000 cases, a truly pan-European coverage of the cohort, was generated with detailed pathological and clinical data and available tissue samples. Technical and organizational measures to ensure data security and protect privacy of the persons contributing their data to CRC-Cohort were discussed in-depth and the agreement on data transfer was reached in compliance with GDPR, taking into consideration the differences in regulatory and ethical issues within the different European Countries.
WP3: Both goals of supporting the process of Europe-wide collection of more than 10,000 CRC cases and delivering the central BBMRI-ERIC IT infrastructure were successfully achieved. Several challenges due to the enormous heterogeneity of the CRC source data and the lack of previous experience in developing a data model to map and enrol this data were overcome. The final collection of 10,440 CRC datasets is a major and unique achievement.
WP4: A workshop was organised with the aim of addressing the sustainability issue and the future of research infrastructures. Delegates from 16 RIs attended the meeting and contributed to its recommendations. An IT tool has been developed to support and monitor access to samples and data as well as to identify the effectiveness of the process. Access procedures and services for researchers were implemented.
WP5: The ELSI Helpdesk and Knowledge Base were conceptualised, implemented and sustained as a user-oriented service within BBMRI. Key achievements include workshops and conference participations with a focus on the GDPR implementation and the work towards a Code of Conduct for Health Research, as well as the survey on informed consent practices and its analysis. Additionally, regular exchanges and collaborations with stakeholders such as EFPIA or EMA well as annual stakeholder events with patient advocacy groups were held.
WP6: In WP6 a handbook for biobanks to meet users’ needs for biomarker discovery, development and validation was produced. The handbook contains a comprehensive package of current best practice documents, regulations and standards important for sample quality; information of BBMRI-ERIC services for auditing and evaluation of biobanks; conformity testing as well as additional guidelines and information collected in several EU projects, consortia and networks. The handbook was published on the BBMRI-ERIC website.
WP7: A section in the BBMRI-ERIC Directory that highlights Rare Disease biobanks was delivered and synergized with efforts in the RD-connect project, the MIABIS standardization effort for minimum information about biobanks and the MOLGENIS open source project. Using the experience gathered within the existing Common Service initiatives and discussing the challenges with the Rare Disease community it became clear that the best and most efficient way forward would be a full incorporation of RD activities in the overall scope of BBMRI-ERIC, using its created infrastructure and governance to yield the most effective, efficient result.
WP8: WP8's main achievements were the accession of 3 new full members (Poland, Latvia, Bulgaria) and one observer (Cyprus) to BBMRI-ERIC, raising the total members of to 21, the highest of any biomedical ERIC. On a global scale, 4 workshops (in China, Brazil, Turkey and Egypt) were organised to disseminate the scientific results of ADOPT and to liaise with the global biobanking communities, helping them to develop networks and knowledge.
WP2: A CRC-Cohort of 10,000 cases, a truly pan-European coverage of the cohort, was generated with detailed pathological and clinical data and available tissue samples. Technical and organizational measures to ensure data security and protect privacy of the persons contributing their data to CRC-Cohort were discussed in-depth and the agreement on data transfer was reached in compliance with GDPR, taking into consideration the differences in regulatory and ethical issues within the different European Countries.
WP3: Both goals of supporting the process of Europe-wide collection of more than 10,000 CRC cases and delivering the central BBMRI-ERIC IT infrastructure were successfully achieved. Several challenges due to the enormous heterogeneity of the CRC source data and the lack of previous experience in developing a data model to map and enrol this data were overcome. The final collection of 10,440 CRC datasets is a major and unique achievement.
WP4: A workshop was organised with the aim of addressing the sustainability issue and the future of research infrastructures. Delegates from 16 RIs attended the meeting and contributed to its recommendations. An IT tool has been developed to support and monitor access to samples and data as well as to identify the effectiveness of the process. Access procedures and services for researchers were implemented.
WP5: The ELSI Helpdesk and Knowledge Base were conceptualised, implemented and sustained as a user-oriented service within BBMRI. Key achievements include workshops and conference participations with a focus on the GDPR implementation and the work towards a Code of Conduct for Health Research, as well as the survey on informed consent practices and its analysis. Additionally, regular exchanges and collaborations with stakeholders such as EFPIA or EMA well as annual stakeholder events with patient advocacy groups were held.
WP6: In WP6 a handbook for biobanks to meet users’ needs for biomarker discovery, development and validation was produced. The handbook contains a comprehensive package of current best practice documents, regulations and standards important for sample quality; information of BBMRI-ERIC services for auditing and evaluation of biobanks; conformity testing as well as additional guidelines and information collected in several EU projects, consortia and networks. The handbook was published on the BBMRI-ERIC website.
WP7: A section in the BBMRI-ERIC Directory that highlights Rare Disease biobanks was delivered and synergized with efforts in the RD-connect project, the MIABIS standardization effort for minimum information about biobanks and the MOLGENIS open source project. Using the experience gathered within the existing Common Service initiatives and discussing the challenges with the Rare Disease community it became clear that the best and most efficient way forward would be a full incorporation of RD activities in the overall scope of BBMRI-ERIC, using its created infrastructure and governance to yield the most effective, efficient result.
WP8: WP8's main achievements were the accession of 3 new full members (Poland, Latvia, Bulgaria) and one observer (Cyprus) to BBMRI-ERIC, raising the total members of to 21, the highest of any biomedical ERIC. On a global scale, 4 workshops (in China, Brazil, Turkey and Egypt) were organised to disseminate the scientific results of ADOPT and to liaise with the global biobanking communities, helping them to develop networks and knowledge.
ADOPT BBMRI-ERIC created the largest biorepository on the globe, with more than 100 million samples included in the Directory. It brought together the largest network of biobanks in Europe and in the world. By gathering 10,000 colorectal cancer data sets from biobanks across Europe, BBMRI-ERIC showed that it is possible for countries with diverse populations to provide samples and their corresponding data for the benefit of future research. On the other hand, this achievement identified the major obstacles to collecting multinational cohorts: reconciling differing national policies on data protection and material and data transfer, overcoming slow logistical processes and combining data from biobanks with very different data input structures. In the end, ADOPT partners were able to address these issues, ultimately collecting 10,440 data sets for future use. We hope that the CRC-Cohort can be used by research communities as an example and for troubleshooting in order to accelerate the sample and data collection process for future research projects.
A solid start has been made with the Stakeholder Forum and its added value is already proven, including involvement of patient organisations, industry and policymakers. BBMRI-ERIC now pressures organizations and project consortia to include relevant stakeholders, especially patients, in project planning. BBMRI-ERIC experts have been providing support on ethical, legal and societal issues as well as quality and IT issues to biobanks across the continent and beyond.
In brief, BBMRI-ERIC and its National Nodes created a solid European biobanking community, supported strongly by ADOPT, and will continue to drive sample access and services with defined management and processes, promoting the comprehensive multinational retrospective collection of 10,000 CRC datasets as a unique demonstrator in creating a true gateway for health.
A solid start has been made with the Stakeholder Forum and its added value is already proven, including involvement of patient organisations, industry and policymakers. BBMRI-ERIC now pressures organizations and project consortia to include relevant stakeholders, especially patients, in project planning. BBMRI-ERIC experts have been providing support on ethical, legal and societal issues as well as quality and IT issues to biobanks across the continent and beyond.
In brief, BBMRI-ERIC and its National Nodes created a solid European biobanking community, supported strongly by ADOPT, and will continue to drive sample access and services with defined management and processes, promoting the comprehensive multinational retrospective collection of 10,000 CRC datasets as a unique demonstrator in creating a true gateway for health.