– Written by Dan Boisvert, Senior Director, Head of Data Stewardship, Biogen

Participant data return is the act of granting clinical trial participants access to the data that was collected about them during a clinical trial. In current clinical trial practice, we take measurements, conduct tests, and perform procedures. The results are reviewed by the investigator and stored by the sponsor, but participants rarely see their own results. For example, if a participant has a biopsy to measure disease progression, the results are never communicated to them. As a result, participants have a gap in their medical records during the clinical trial, and after the trial, they do not have their data to help them decide whether to continue to receive care.

Introduction

In spring 2025, PHUSE established the Participant Data Return Working Group, with the aim of highlighting current industry practice and identifying gaps and challenges in implementation to speed industry uptake. As a first action, in summer 2025, we assessed the current state of data return throughout the industry by surveying PHUSE member companies. PHUSE received a total of 14 responses representing 14 companies worldwide. Study respondents were asked to share their organisations’ practices and perspectives on returning data to clinical trial participants.

Summary of Survey Results

The survey shows nascent industry adoption, with only one company having formal policy in place. Other companies are split – most (5/7) are considering standardising the practice. Still, half (7/14) do not return participant data. Respondents call out challenges relating to Technical Limitations (5/8), Cost Considerations (5/8), Data Privacy Concerns (4/8) and Ethical Concerns (3/8). In terms of facilitating adoption, respondents highlight that Standardised Industry Practices (4/7) and Improved Technology Solutions (4/7), as well as Clear Regulatory Guidance (3/7), Increased Participant Demand (3/7) and Organisational Support (3/7), would help.

Next Steps

The PHUSE Participant Data Return Working Group identified Standardised Industry Practices and Improved Technology Solutions as key areas where we could make impactful contributions. PHUSE has a history of successfully moving these two objectives forward in other domains, and that expertise can be leveraged here. This Working Group aims to be complementary and build on the fantastic work by TransCelerate (https://www.transceleratebiopharmainc.com/initiatives/participant-data-return/), MRCT (https://mrctcenter.org/project/return-of-individual-results/) and IMI FACILITATE (https://facilitate-project.eu/).

Based on this survey, the PHUSE Participant Data Return Working Group decided on two actions:

1. Publish a playbook: The playbook will offer current cross-industry perspective on common implementation questions, serving as a first documentation of standardised industry practice.
2. Showcase technology vendors: Since participant data return requires sponsors to work with a third party as a bridge to the participants, knowledge of technology offerings in this space will enable organisations to make decisions.

Want To Get Involved?

Please reach out to workinggroups@phuse.global to join the Working Group.

If you are a technology vendor in this space and would like to be highlighted, please contact workinggroups@phuse.global.

Survey Results

Organisational Representation

Respondents represented a diverse range of organisations:

• Pharmaceutical companies: 64.29% (9 respondents)
• Biotech companies: 28.57% (4 respondents)
• Contract research organisations (CROs): 0.00%
• Academic institutions: 0.00%
• Healthcare providers: 0.00%
• Regulatory agencies: 0.00%
• Other: 7.14% (1 respondent)

Organisational Roles

The roles of respondents within their organisations were varied:

• Transparency/Data Sharing: 64.29% (9 respondents)
• Clinical Research: 14.29% (2 respondents)
• Data Management: 0.00%
• Regulatory Affairs: 0.00%
• Ethics and Compliance: 7.14% (1 respondent)
• Patient Engagement: 7.14% (1 respondent)
• Information Technology: 0.00%
• Other: 7.14% (1 respondent)

Current Practices of Data Return

When asked if their organisation currently returns data to clinical trial participants, responses were evenly split:

• Yes: 50.00% (7 respondents)
• No: 50.00% (7 respondents)

Types of Data Returned

For organisations that do return data, the types of data typically returned include:

• Individual clinical results (e.g. lab test results, biomarkers): 75.00% (3 respondents)
• Aggregate study results: 75.00% (3 respondents)
• Genetic data: 25.00% (1 respondent)
• Imaging data: 25.00% (1 respondent)
• Other: 25.00% (1 respondent)

Formality of Data Return Practices

The level of formality in data return practices varied:

• Company policy: 20.00% (1 respondent)
• Departmental SOPs: 20.00% (1 respondent)
• Pilots and PoCs: 40.00% (2 respondents)
• Ad hoc: 20.00% (1 respondent)
• None: 0.00%
• Industry guidelines: 0.00%
• Regulatory mandates: 0.00%

Methods of Data Return

The methods used to return data to participants include:

• Secure online portals: 40.00% (2 respondents)
• Paper-based reports: 20.00% (1 respondent)
• Direct communication with healthcare providers: 60.00% (3 respondents)
• Mobile applications: 20.00% (1 respondent)
• Email or electronic documents: 20.00% (1 respondent)

Challenges in Returning Data

The primary challenges faced in returning participant data are:

• Regulatory restrictions: 25.00% (2 respondents)
• Data privacy concerns: 50.00% (4 respondents)
• Legal/IP concerns: 25.00% (2 respondents)
• Technical limitations: 62.50% (5 respondents)
• Cost considerations: 62.50% (5 respondents)
• Ethical concerns: 37.50% (3 respondents)
• Lack of participant demand: 12.50% (1 respondent)

Ensuring Participant Understanding

To ensure participants understand the returned data, organisations take various measures:

• Provide lay summaries: 75.00% (6 respondents)
• Work with healthcare providers: 37.50% (3 respondents)
• Develop educational materials: 37.50% (3 respondents)
• Conduct follow-up discussions: 25.00% (2 respondents)

Organisational Policies on Data Return

Regarding organisational policies on data return as standard practice:

• Yes, we have a formal policy: 14.29% (1 respondent)
• No, but under consideration: 71.43% (5 respondents)
• Not sure: 14.29% (1 respondent)

Facilitating Data Return

To facilitate participant data return, organisations identified several key factors:

• Clear regulatory guidance: 42.86% (3 respondents)
• Improved technology solutions: 57.14% (4 respondents)
• Increased participant demand: 42.86% (3 respondents)
• Standardised industry practices: 57.14% (4 respondents)
• Organisational support: 42.86% (3 respondents)