The CDDF Diversity Initiative is a CDDF-sponsored and directed project with a multi-stakeholder working group of regulators, payers, patients, academic researchers, and pharmaceutical companies.
This initiative aims to examine parameters of inclusion/diversity to support planning and evaluation of clinical research and the applicability of clinical trial outcomes to Europe’s diverse population.
Objectives
- To review and summarize the existing research, guidance and data on variables that capture diversity and representativeness relevant for oncology clinical trials.
- To describe a set of variables relating to diversity and representativeness that can serve to plan and evaluate oncology clinical trials for their applicability to Europe’s population.
- To include the perspectives of key stakeholders: patients, healthcare professionals, academia, pharmaceutical industry, HTA views and medicines regulators.
- To consider the impact of such datasets on clinical trial planning/advice, conduct and evaluation of outcomes including for regulatory assessment / benefit-risk determination as well as HTA assessment.
key deliverables
- To publish a consensus paper describing the selected variables, rationale for their selection, methodological approaches and respective best practices for clinical trials and studies with the related stakeholder perspectives.
- To outline open questions for further research.
- To publish a systematic review, if possible with a meta-analysis, of published data and guidance
Accompanying research
- Qualitative/quantitative research and systematic review on possibly relevant diversity dimensions, to be completed as part of Phase 2
- Expected Outcomes:
- White paper/Consensus paper after development of data item set in focus groups.
- Publication of systematic review on existing diversity data item sets for use in clinical trials.
- Publication on feasibility of capturing diversity using the proposed data set in oncology.
Benefits
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A paper agreed with a cross section of key stakeholders setting out an approach for and parameters for addressing EU patient diversity in oncology clinical trials and observational studies.
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In the absence of other guidance specific for the EU, it provides a reference point for developers, researchers and regulators when advising on, planning or conducting a clinical trial/study and when evaluating the clinical data produced for relevance to EU populations.
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It offers an alternative perspective and approach to that applicable in the USA, as well as input to future guidance that may be developed at EU level on this topic.
Project Outline
Preparation: Aug-Sep 2024
- Establish a co-ordinating committee
- Establish a working group
Phase 1: Oct-Dec 2024
- Scoping discussion, incl. objectives and deliverables
- Outline what population variables are relevant to EU
- Clarification of phase 2 objectives, budget, work packages and resource requirements
- Decision whether to proceed with Phase 2, or modify Phase 2
Phase 2: Jan-Dec 2025
- Establish collaboration with academic research group
- Define population descriptions relevant to oncology patients in the EU and what data elements and references can support these
- Preparation of systematic literature review and publication
- Work on feasibility of capturing diversity using the proposed data set in oncology leading to a publication.
- Suitability of diversity data for use in regulatory decision-making
- Conduct of work packages including meetings for topic discussions, workshop to present and review consensus paper
- Finalisation and publication of consensus paper
- Closure of project
Organization Committee & Working Group
Organization Committee
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- Axel Glasmacher (CDDF)
- Fergus Sweeney (CDDF)
- Harald Enzmann (BfArM)
- Marie Von Lilienfeld-Toal (Ruhr-Universität Bochum)
- Birgit Wolf (Bayer)
- Sushmita Sen (Roche)
Working Group
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- To be nominated soon