The READI project is inviting stakeholders across the clinical research ecosystem to help refine draft recommendations for collecting participant characteristics more consistently in clinical studies. Developed by a multidisciplinary READI team coordinated by University Medical Center Utrecht (UMCU), the proposed participant-facing questions and response options are now being opened to wider review before the recommendations are finalised.
Understanding who is represented in clinical research requires meaningful information about study participants. Characteristics such as age, sex, gender, socioeconomic circumstances or geographic location can help researchers assess patterns of participation and identify where some groups may be underrepresented.
Yet collecting this information consistently is not straightforward.
Across clinical studies, similar characteristics may be described using different terminology, questions or response categories. In Europe, this challenge is particularly complex because population composition, national contexts, data standards and approaches to sensitive information can differ. Some characteristics may also raise important ethical, legal, privacy or implementation considerations.
These differences can make it more difficult to compare participant information across studies and countries and, ultimately, to understand patterns of representation in clinical research.
How is READI addressing this challenge?
Within READI, a multidisciplinary group of partners is working on one specific part of this wider challenge:
How can relevant participant characteristics be collected more consistently when collecting that information is appropriate to a particular clinical study?
The work does not seek to determine which populations are underserved or underrepresented, nor does it propose that every clinical study should collect every characteristic.
Questions around why and when particular characteristics should be collected form part of the broader READI work on representation and study design.
This work instead focuses on the how: developing participant-facing questions and response options that can support more consistent collection when a characteristic is relevant to the study context.
The work is coordinated by University Medical Center Utrecht (UMCU) and brings together READI partners from academia and clinical research, healthcare, patient organisations, pharmaceutical industry, regulatory and health technology assessment, data standards, and other relevant areas of the clinical research ecosystem. This multidisciplinary involvement helps ensure that the proposed questions are considered not only from a scientific perspective, but also in terms of participant acceptability, implementation, data consistency and regulatory relevance.
Developing the questions through a modified Delphi study
To develop the proposed questions and response options, the READI study team used a modified Delphi approach.
The starting point was informed by six characteristics from the PRO-EDI framework:
- age;
- sex;
- gender;
- race and ethnicity;
- socioeconomic status; and
- geographic location.
Preparatory work also examined how participant characteristics are currently collected and reported in clinical research. This included reviewing existing data collection approaches, relevant data standards and reporting practices.
A multidisciplinary expert panel then reviewed the proposed participant-facing questions and response options. The panel brought together perspectives from academia and clinical research, industry, patients and patient organisations, regulatory and ethics, health technology assessment, policy, clinical data standards and other relevant fields.
Across two survey rounds and an expert consensus meeting, participants assessed and refined the proposals, considering the clarity of the questions, suitability of the response options, feasibility of collection in European clinical studies, and ethical and legal acceptability.
Importantly, the process also changed the scope of the work.
During the Delphi study, experts proposed two additional characteristics:
- digital access and digital literacy; and
- disability.
These were subsequently evaluated through the Delphi process and included in the draft recommendations. The proposed set therefore now covers eight participant characteristics.
This provides a practical example of how stakeholder input has already helped shape the recommendations.
Why is a wider consultation needed?
The Delphi process has helped the READI team develop and refine a proposed approach, but the recommendations are not yet final.
The next step is to test them with a wider group of stakeholders.
Through the public consultation, READI is inviting people and organisations involved in clinical research to review the proposed questions and response options and assess whether they are:
- clear;
- appropriate;
- feasible; and
- broadly applicable across clinical studies in Europe.
Different stakeholders may identify different issues. A question may be scientifically useful but difficult for participants to understand. A response option may be clear but difficult to implement consistently. An approach may work in one national context but raise ethical, legal or practical concerns in another.
This is why wider input is an important part of developing the recommendations rather than simply a way of sharing completed work.
How will your feedback make a difference?
Feedback received through the consultation can influence the final recommendations.
After the consultation closes, all comments will be reviewed by the READI study team. Feedback relating to clarity, consistency or readability will be considered when preparing the final recommendations, while more substantive methodological, scientific, ethical, legal or implementation issues will be discussed by the team.
Where substantial issues require further consensus, they may be brought back to members of the Delphi expert group for further consideration before the recommendations are finalised.
READI will also prepare a summary of the consultation feedback and the actions taken following the consultation process.
In other words, this consultation is not asking stakeholders simply to endorse a finished approach. It is an opportunity to test, challenge and help refine it.
Who should contribute?
READI welcomes input from stakeholders involved in the design, conduct, oversight, interpretation or experience of clinical studies.
This includes patients and patient organisations, clinical researchers and academics, investigators and clinical sites, industry, regulatory and ethics stakeholders, health technology assessment bodies, data standards specialists, policymakers and other relevant stakeholders.
Each perspective can help assess the proposals from a different angle — from participant understanding and acceptability to scientific relevance, implementation, data consistency and applicability across European contexts.
Help us test the proposed approach
The central question is practical:
When collecting a participant characteristic is relevant and appropriate to a clinical study, how should we ask about it?
The modified Delphi process has taken the work to a draft consensus-based set of recommendations. Now READI is asking the wider clinical research community to help test them before they are finalised.
Review the proposed questions and response options and tell us what is clear, what may not work in your context, and what should be reconsidered.
Take part in the READI public consultation:
The consultation is expected to remain open for approximately six weeks, until November 6, 2026.
