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Work packages

Launched in May 2018, PIONEER has a 5 year deadline in which to accomplish its objective of gathering, harmonising, analysing and combining broad data-sets on the diagnosis and treatment of Prostate Cancer into a comprehensive big data platform.

To achieve its goal PIONEER has developed 8 individual work packages: project management and coordination (WP 1), 4 core research themes (WP 2-5) and 3 cross-cutting support themes (WP 6-8). For a detailed overview of each work package’s objectives and achievements to boxes below.

Work package 1 project management & administration

WP1 will provide an effective project management programme and governance structure to ensure that PIONEER’s objectives are successfully fulfilled within the lifetime of the project. WP1 will facilitate collaboration between the consortium’s partners whilst ensuring all IMI2 requirements are respected.

Objectives:

  1. Establish a project management and governance structure which will allow effective execution of the project, including technical and financial reporting, risk management processes and conflict resolution, critical path analysis for each WP, timely decision making and accountability.
  2. Ensure effective communication and collaboration between consortium members both within individual WPs and across the different WPs; therefore, ensuring that the entire consortium works together as a team to achieve PIONEER’s objectives.
  3. Identify sort- and long-term sustainability strategies to ensure that the results generated by PIONEER are effectively implemented, built upon and integrated into future projects.
  4. Develop the necessary mechanisms to ensure coordination with the Big Data for Better Outcomes programme, and collaboration with other relevant projects and initiatives.

Partners: European Urology Association, ASSOCIATION EISBM, University of Lund, Universita Vita-Salute San Raffaele, Bayer, Sanofi, Astellas Pharma and ttopstart.

Work package 2 disease understanding & outcome definitions

WP2 will develop standardised definitions of prioritised prostate cancer outcomes and diagnostic and prognostic factors across the different stages of prostate care, whilst taking into account existing heterogeneity in data collection and the disease itself. WP2 aims to directly inform guideline development and clinical practice by standardising definitions and terminology regarding diagnosis, prognosis and outcomes for prostate cancer. The most important outcomes for different stakeholders will be prioritised and defined and a core outcome set will be developed for different stages of the disease. For each of the outcomes identified as core, the most appropriate and feasible outcome measurement instrument will be recommended. Consensus will also be sought for diagnostic tests and parameters, and prognostic factors. WP2 will feed into WP3, 4 and 5, whilst the results from WP4/WP5 will feedback into WP2.

Objectives:

  1. Identify core outcome sets and diagnostic and prognostic factors for localised, locally advanced, and advanced-metastatic prostate cancer in the context of the patient’s treatment pathway, including quality of life, patient-reported outcomes and economic endpoints.
  2. Assess how these outcomes and diagnostic and prognostic factors should be prioritised and recommend a valid and feasible outcome measurement instrument for each of the outcomes.
  3. Disseminate findings and guidelines to health practitioners and patients to improve management and care of men with prostate cancer in close collaboration with WP7.

Key achievements to date:

  1. Four systematic reviews completed for the core outcome sets for the four different prostate cancer stages
  2. Four expert group meetings, combination of face-to-face and virtual, were conducted in support of the core outcome set work and the systematic review on diagnostic and prognostic factors.
  3. Ethical approval for qualitative interviews granted in the UK and applied for in Germany and the Netherlands.
  4. Five abstract presentations presented.

Partners: European Association of Urology, King’s College London, Universita Vita-Salute San Raffaele, International Consortium for Health Outcomes Measurement, University of Aberdeen, European Organisation for Research and Treatment of Cancer, Bayer, Sanofi, Janssen Pharmaceutical, Orion Corporation and Astellas Pharma.

Work package 3 data access & sources

WP3 will address the challenges related to identifying and prioritising potential data sources; negotiating appropriate data access agreements; homogenisation of data and the establishment of data management plans to support the long-term sustainability goals of PIONEER. To achieve its objectives WP3 will work closely with WP4 and WP8.

Objectives:

  1. Identification of potential data contributors. WP3 have already identified a number of potential data contributors as part of the initial stages of PIONEER and will continue to work with these groups to ensure their interests, and those of PIONEER, are aligned allowing for the implementation of Data Access Agreements.
  2. Data needs and data gap assessments. These assessments will provide a bridge between the research questions and the data sources and help to identify which data sources can be used to address PIONEER’s prioritised research questions, as well as identifying where there may be specific data gaps within PIONEER’s network of data contributors.
  3. WP3 will work closely with WP8 to develop a Data Access Agreement for data contributors. This agreement will specify whom, and under what circumstances, PIONEER researchers have access to the data. It will also specify what tasks the data contributor has agreed to undertake, and what (if any) compensation they would expect in exchange for providing access to their data.
  4. Conversion and harmonisation of data. WP3 will collect metadata on each data source to produce a data catalogue. The data catalogue will allow PIONEER researchers to identify specific data sources that may be applied to the research question they are asking. WP3 will use the approaches successfully established by previous IMI projects, specifically EHR4CR, EMIF and eTRIKS, to harmonise data while maintaining security and consistency.

Key achievements to date:

  1. First two academic datasets (PRIAS & ERSPC) made available in the PIONEER Big Data platform by PIONEER partner Erasmus University Medical Centre (MC).
  2. First Data Sharing Agreement signed with external data contributor Active Biotech AB.
  3. Five industry datasets from three EFPIA partners have been made available for the platform.

Partners: Erasmus Universitair Medisch Centrum Rotterdam, The Hyve B.V., Bayer, University of Lund, University of Tampere, Technische Universität Dresden, Fraunhofer IZI, Goeteborgs Universitet, Radboud University Medical Center, European Organisation for Research and Treatment of Cancer, Universitaetsklinikum Hamburg-Eppendorf, Varian Medical Systems, Astellas Pharma and Covance.

Work package 4 data platform

The main aim of WP4 is to deliver a data repository and analytics platform that is secure, sustainable and meets PIONEER’s objective to improve prostate cancer outcomes by identifying the relevant outcome measures from epidemiological, clinical, economic and, patient-reported outcome data. To achieve its aim WP4 will work closely with WP3 and WP5.

Objectives:

  1. Provide a centralised catalogue that is secure and allows for efficient upload, storage and management of the metadata of available prostate cancer data sets to facilitate sharing of and access requests to the data sets, for the duration of the PIONEER project and beyond.
  2. Establish a population-based registry platform to allow epidemiological research.
  3. Establish an omics analysis platform to allow researchers to combine clinical and omics group data for biomarker and other omic-based research.
  4. Provide tools for the curation and harmonisation of the data hosted on the various platforms, and most importantly, provide training to the consortium on how to use these tools.
  5. Provide input into the development of novel informatics tools.

Key achievements to date:

  1. EMIF catalogue with information on the PIONEER datasets.
  2. Centralised data platform consisting of OHDSI OMOP environment for sharing and analysis of real-world data and a JupytherHub environment to enable combined analysis on real-world population health (or clinical data) and omics data.
  3. Temporary hackathon environment on Amazon supporting OMOP-Atlas, JupyterHub and SAS analytics tooling.

Partners: The Hyve B.V., ASSOCIATION EISBM, Varian Medical Systems, Imperial College of Science Technology and Medicine, Bayer, Radboud University Medical Center, Astellas Pharma and Orion Corporation.

Work package 5 data analytics

The main aim of WP5 is to carry out analyses of the data sources identified and collated by WP3 and WP4 based on the core outcome sets for localised, locally advanced, and advanced-metastatic prostate cancer identified by WP2 in order to answer, or provide opportunities to answer, the main questions related to prostate cancer.

Objectives:

  1. Develop a data analysis plan and standard operating procedure for each major research objective to ensure transparency and effective communication for all stakeholders.
  2. Carry out data exploration, visualisation and basic statistics in a way that uncovers new insights into the research questions being asked.
  3. Implement data quality control measures to ensure data errors and outliners are identified and controlled for ensuring the most reliable data possible.
  4. Develop predictive models of patients outcomes, disease progression and therapy selection based on advanced analytics. This will include investigating the added value of clinical and biological biomarkers in improving predictions throughout the care pathway of prostate cancer.
  5. Assess the performance of new predictive models over existing methods and develop a clinician/patient scoring and evaluation process.
  6. Pilot patient evaluation and treatment strategies based on these new predictive analytical tools and models, as it is vitally important to measure the acceptance and adherence of both patients and clinicians.
  7. Utilise the PIONEER database to estimate the economic burden of prostate cancer depending on the disease stage and geographic region in which the patient lives. The outputs will be useful to inform policy issues, and provide useful inputs to WP6.

Key achievements to date:

  1. PIONEER virtual hackathon 12 hours, 62 volunteers engaged on 7 channels, 31 concept sets created, 5 cohorts defined, 2 working R scripts and 4 SAS analyses created – and the work is only just starting! Look out for our studyathon in Autumn 2020!

Partners: ASSOCIATION EISBM, Erasmus Universitair Medisch Centrum Rotterdam, Universitaetsklinikum Hamburg-Eppendorf, European Organisation for Research and Treatment of Cancer, Imperial College of Science Technology and Medicine, Weizmann Institute of Science, Fraunhofer IZI, Swedish Institute for Health Economics, Astellas Pharma, SAS Institute, Orion Corporation and Bayer.

 

Work package 6 HTA regulator-payer integration

The main aim of WP6 is to identify and address evidence gaps which can delay decision-making by regulatory agencies, health technology assessment (HTA) bodies and payers, which ultimately compromises timely patient access to innovative treatments for prostate cancer. WP6 will build upon previously gained experience in other EU-funded projects and international initiatives and will provide advice and support to work packages 2, 3, 4 and 5 to ensure that the HTA-, patient-, regulator-, and payer-relevant perspectives are reflected.

Objectives:

  1. Develop an ‘evidence framework’ for centralised regulatory approval and national/regional HTA across EU member states to support the decision-making processes for market access of innovative treatments for prostate cancer.
  2. Develop a ‘clinical value framework’ to assess the magnitude of clinical benefit/added therapeutic value offered by a new medicine in relation to the available therapies for prostate cancer, integrating the feedback from WP2 and other relevant partners in the scope of their respective responsibilities.
  3. Ensure uptake of PIONEER’s findings by key stakeholders; therefore, facilitating adoption of new policies and increasing policy change regarding the treatment of prostate cancer all aimed at sustainable long-term implementation of PIONEER’s outcomes.

Key achievements to date:

  1. Expert Committee Policy Stakeholder Feedback Forum (ECPSFF) members identified and recruited​.
  2. 1st Policy Paper​ published.
  3. Key issues in prostate cancer HTA visualisation.
  4. High level overview of HTA outcomes in prostate cancer to date (IHE) in UK, Sweden, France and Germany​.
  5. Stakeholder face to face discussion at EMUC Nov 2019.
  6. Session in EAPM Presidency Conference entitled, “Defining the healthcare ecosystem to determine value”, on March 24th, 2020.

Partners: European Alliance for Personalised Medicine, Swedish Institute for Health Economics, Janssen Pharmaceutical, Bayer and Sanofi.

Work package 7 dissemination & communication

WP7 will run in parallel with the other packages during the entire lifecycle of the project and focuses on dissemination and communication of the project’s aims, objectives and results. Its key aim is the widest possible dissemination of the project’s results to both the research community and all other interested/identified stakeholders. IMI supports collaborative research projects and builds networks of industrial and academic experts to boost pharmaceutical innovation in Europe. WP7 aims to establish links with this community, facilitating effective communication with the other BD4BO projects to ensure that PIONEER’s objectives are well known.

Objectives:

  1. Communicate information to the public about the project and its implementation status.
  2. Coordinate communication between consortium members and the public through dedicated project website and social media platforms.
  3. Coordinate communication activities with other relevant research and stakeholder networks.
  4. Contribute to PIONEER pilot studies through the production of educational material where appropriate to increase knowledge of the designed tools amongst clinicians and patients.
  5. Provide for the dissemination of project developed platforms for use by the wider scientific community.
  6. Disseminate the results of the project to target audiences and key stakeholders, including policymakers.

Key achievements to date:

  1. PIONEER dissemination and communication strategy.
  2. Development of the PIONEER visual identity including project logo and house style.
  3. PIONEER website and Twitter account.
  4. Project brochures – scientific and patient versions.
  5. PIONEER project interviews – filming and editing.
  6. PIONEER animated video production.
  7. Quarterly PIONEER newsletter.

Partners: European Association of Urology, European Cancer Patient Coalition, ecancer Global Foundation, Bayer and Sanofi.

Work package 8 legal ethics & governance

The main aim of WP8 is to develop a legal and ethical framework to provide guidance on addressing patient confidentiality and data ownership concerns, and establish sustainable governance for the data infrastructure. The timing of PIONEER will coincide with the coming into force of the General Data Protection Regulation (GDPR) in May 2018, the most significant change in data privacy law in over 20 years. WP8 will closely track how EU members States may derogate from GDPR and how regulatory or professional bodies provide specific guidance on application to patient data and big data. WP8 collaborate with, and provide guidance to other WPs (3, 4 and 5 in particular). WP8 will develop and share best practice as it emerges throughout the term of the lifetime of PIONEER and report regularly on progress.

Objectives:

  1. Map issues which are affecting or blocking big data (collection, processing and sharing), and best practices regarding governance of big data in healthcare interaction.
  2. Analysis of the governance features and consents of PIONEER databases and integration. WP8 participants will actively provide input into legal, regulatory and ethical issues arising from other WP activities, particularly with regard to the underlying consents and/or restrictions surrounding the existing data sources.
  3. Guidance and Legal Advice to facilitate responsible use of data during PIONEER. This will include legal aspects such as patient consent, patient confidentiality and data ownership, having regard to applicable legislation (and regulatory/ethical factors).

Key achievements to date:

  1. Drafting and finalising two standard form template Data Sharing Agreements which allow transfer and processing of data in accordance with legal, regulatory and ethical requirements (with different versions of the Data Sharing Agreement to reflect both the Centralised and Federated Database Models).
  2. WP8 has also prepared a Data Processing Agreement in order to allow data conversion by The Hyve for WP3 and WP4.

Partners: European Organisation for Research and Treatment of Cancer, Pinsent Masons LLP, ASSOCIATION EISBM, Bayer, Astellas Pharma and Orion Corporation.