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Prostate Cancer DIagnOsis and TreatmeNt Enhancement through the Power of Big Data in EuRope

Periodic Reporting for period 3 - PIONEER (Prostate Cancer DIagnOsis and TreatmeNt Enhancement through the Power of Big Data in EuRope)

Reporting period: 2020-05-01 to 2021-04-30

Prostate Cancer (PCa) is the second leading cause of cancer, among men in Europe. There are currently major unmet needs in this field, such as insufficient knowledge on risk factors that contribute to PCa and on patient characteristics (including genetic profiles) that could facilitate patient stratification. There is lack of meaningful engagement of all key stakeholders, while the knowledge currently gained from clinical practice and real-life data is not being fed back into PCa patients’ care pathways. There is thus a need for better definition of PCa across all stages, improved patient’s stratification at diagnosis, and standardisation of PCa-related outcomes based on real life data. PIONEER’s unique dual approach is to first identify critical evidence gaps in PCa by respected Key Opinion Leaders, embark on a research priority setting exercise that reflects the needs of all key stakeholders in PCa management, and then proceed to answer the questions prioritised by the stakeholders. To achieve this, PIONEER identified and is bringing together comprehensive data-sets that consists of the most relevant PCa clinical trials and registries, large epidemiological cohorts, electronic heath records, and real-life data from different European (and non-European) patient populations. These unique data sets will be integrated, standardised, harmonised and analysed using a unique set of methodologies and advanced analytics methods. PIONEER has already performed a PCa research priority setting exercise, where major stakeholders were asked through two rounds to identify the current unmet needs in PCa. The five most important open questions will be used as pilot studies to verify PIONEER’s research framework. As such, PIONEER’s deliverables will be outcome-driven, value based and patient-centric, and relevant to all key stakeholders, as they would have been meaningfully involved from the inception of the project.
The PIONEER project contains of 8 Work Packages:
WP1 - Project Management - aims to ensure efficient management and progress of the project towards its planned objectives and deliverables.

WP2 - Disease understanding and outcome definition - aims to develop standardized definitions of prioritized PCa core outcomes set (COS) and diagnostic and prognostic factors (DPFs) across the different stages of PCa. Most of the WP2 tasks are now completed.

WP3 - Data access and sources - will use a variety of approaches and software to enable access, harmonization, integration, and linkage of multiple big data sets. So far, WP3 has identified 95 data sources and 44 completed fact sheets have been received and the data input into the EMIF catalogue where PIONEER members can assess which data sources contain the most relevant information for the research question they wish to answer. 12 datasets have been converted to the OMOP-CDM and are available in the PIONEER platform and 21 data sources are ready for conversion.

WP4 - Data platform - will develop a cutting-edge, informatics platform, where a diverse set of standardized and high-quality data and sources will be consolidated. WP4 installed an OHDSI-OMOP platform on a central server (in HZDR) to support federated data analysis on real-world population health data and on data from trials and cohort
studies and a JupyterHub instance has been deployed on the same server to enable combined analysis on real-world, clinical, and omics data.

WP5 - Data analytics - will provide a unique toolkit of standard and cutting-edge analytical methods for big data sources. So far WP5 has produced a generic data analysis plan (DAP) and a generic protocol template and has organized a hackathon and a studyathon.

WP6 - HTA regulator payer integration - aims to develop a platform that will facilitate the integration of HTA-regulator-payers and to understand the current regulatory and payer/HTA landscape. So far, WP6 has set-up a stakeholder forum referred to as expert committee policy stakeholder feedback forum (ECPSFF), which is consulted on key topics and problems during the project lifetime. In addition, WP6 has identified 4 key emerging evidence areas specific for PCa that may lead to HTA/regulator disconnections, which formed the basis of their first policy paper.

WP7 - Dissemination and communication - aims to disseminate PIONEER’s outcomes to a wide audience. So far, WP7 has developed and is maintaining a D&C strategy, visual identity and branding, project website, active Twitter account, communication toolkit, patient brochure, animated video, video interviews with WP leads, infographics, publication of a Nature Reviews Urology article and several poster presentations.

WP8 - Legal, ethics and governance - aims to establish a robust ethical and legal framework to provide guidance on issues that may arise from the use of ‘big data’ from human participants. So far, WP8 has ensured this by providing documents, advice and support to other WPs. For example: Letter of Intent (LOI), template collaboration agreement, Data Sharing Agreements (DSA) templates, Data access policy, Memorandum of understanding with EHDEN and Liaison with Harmony, and other BD4BO projects.
It is the ultimate ambition of the PIONEER consortium to provide the best possible care for each individual with PCa and to ensure, where possible, that these people preserve their quality of life. PIONEER aims to be the cornerstone for better harmonisation of PCa care across Europe (and beyond) and has implemented activities to support this.

PIONEER has the best experts in the field of PCa on board, as well as patient representatives/organisations and experts on big data and analytics, both from academia and industry. This unique, multidisciplinary and multi-stakeholder consortium together with KOLs (e.g WP6’s ECPSFF, and Advisory Boards) will come together to address the current challenges that PCa patients face. The work done by WP2 will provide valuable insights into the disease definition and will deliver a core set of PCa-related outcomes and DPFs that all the relevant stakeholders agree upon. At the end of the project, the PIONEER consortium will produce evidence-based recommendations for the standardisation of PCa outcomes and DPFs.

Leveraging the existing data platforms, such as the OMOP common data model, PIONEER will create a cutting-edge, informatics platform, where a diverse set of standardised and high-quality data and sources will be consolidated. This platform will meet the specific needs of PCa. Using a unique toolkit of standard and cutting-edge analytical methods (WP5), PIONEER will enable harmonisation, integration, linkage and analysis of multiple big data sets from a variety of sources as already identified by WP3. At the end of PIONEER, we will have developed a large and harmonised repository of PCa data that can be used to improve evidence-based decision-making for all PCa patients.

In the future, this repository will enable all researchers and healthcare professionals to construct enquiries to address research and clinically relevant questions that are not the primary objectives of PIONEER. To control this process, a research committee has been established, consisting of PIONEER members from both industry and academia, to review and approve proposals for new RQs on behalf of the managing board.