Individual Participant Data Return Solutions And Strategies

By Paula Boyles, external clinical trial data-sharing program lead, Pfizer

The concept of individual participant data return (iPDR) has gained significant traction as clinical trial participants increasingly seek access to their study information. Many desire to bridge the gap between clinical research and clinical care by using iPDR to make more informed healthcare decisions.

Likewise, sponsors recognize the broad potential of iPDR to expand their ability to:

• demonstrate value and respect for clinical trial participants,
• empower clinical trial participants to be equal partners in improving their health outcomes,
• enhance patients’ trust by increasing clinical trial transparency, which may lead to a greater diversity of patients who are willing to participate in clinical trials, and
• improve health equity and clinical trial access.

Despite the potential benefits, however, significant operational challenges exist regarding how, when, and what types of participant data can be returned. In addition, some participants do not want access to their study data, which makes optionality crucial.

Therefore, sponsors must determine how to return participant data meaningfully, securely, and safely while maintaining scientific integrity and submission timelines. It’s not easy, but it is possible. No barrier is insurmountable. Numerous groups are working together to solve the challenges and deliver publicly available solutions.

Collaborative iPDR Solutions

For the purposes of this article, iPDR is defined as a study participant’s individual data that is distinct from a return of layperson summary of aggregate results. Examples of iPDR may include:

• health data collected from and generated by a participant throughout a clinical study, including protocol-defined screening and enrollment data
• information and test results that do not constitute study results but are derived from procedures defined within the study protocol and schedule of assessments/activities
• information and test results that do not constitute study results but are derived from samples collected from the participant during the clinical trial

Delivering such data meaningfully and compliantly to the participants who want it cannot be accomplished in isolation — especially if we hope to enable iPDR at scale. A collaborative approach is essential. Fortunately, many organizations with iPDR initiatives underway are already working hand-in-hand to advance and build upon one another’s solutions.

For example, Pfizer was the first sponsor organization to implement iPDR at scale. However, its initial Participant Data Return solution was developed by working closely with the Return of Individual Research Results initiative at the Multi-Regional Clinical Trials (MRCT) Center of Brigham and Women’s Hospital and Harvard. Similarly, many of us who serve on the Innovative Health Initiative (IHI) FACILITATE team also sit on TransCelerate Biopharma Inc.’s Participant Data Return Initiative team.

Indeed, TransCelerate built upon previous knowledge to create pragmatic resources to guide sponsor organizations wishing to launch iPDR initiatives. Sponsors are encouraged to use the freely available Individual Participant Data Return (iPDR) Package, which includes four main components:

• The socialization presentation is meant to educate organizations on iPDR’s potential value and obtain support for operationalizing it. The presentation is customizable to sponsors’ needs and can be used at any stage of the iPDR journey.
• The considerations guide is meant to provide sponsors interested in an iPDR strategy with deeper understanding and awareness. It addresses topics such as how to build a business case, identify impacts, and determine which data to return to whom.
• The customizable template is designed to help operationalize iPDR at the program or study level. It’s important to make decisions about data to be returned to participants before a study begins. So, the template is meant to facilitate decision-making and align stakeholders as they determine how to enable the iPDR option.
• A webinar and corresponding FAQ present further details about TransCelerate’s iPDR initiative, offer a general panel discussion about iPDR, and answer sponsor questions.   

As these tools were developed, collaborations with patients, site advisory boards, clinical research organizations, and others helped ensure they were specific enough to be useful but broad enough to meet the needs of various stakeholders. In addition, TransCelerate’s iPDR Package’s extensive reviews included impact assessments for the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) E6(R3) and E8(R1) guidelines. Therefore, it offers a good starting point for sponsor organizations as they evaluate how to implement iPDR.

Strategic Lessons Learned

Sponsor organizations are slowly but steadily starting to return individual participants’ results and share their experiences with colleagues. Along with toolkits and road maps, some early adopters of iPDR have shared strategies for addressing common challenges faced with implementation and adoption. Some suggestions include:

• Communicate why as well as what. iPDR has implications across multiple aspects of clinical trial operations. Sponsors, therefore, must be sure to clearly communicate two things to their internal teams: 1) what they are doing and 2) why it’s so important. iPDR’s role in building trust in clinical research, empowering participants, and improving global health equity can be emphasized. Engagement of all stakeholders is essential for a successful implementation.
• Prioritize change management. For iPDR to succeed, it cannot be operationally burdensome. It must become a streamlined part of standard study conduct, or it’s simply not feasible. Consequently, change management must be prioritized, and solutions must be embedded into operational processes.
• Set realistic expectations. Enter any iPDR initiative knowing that solutions cannot satisfy 100% of what is desired or be available to 100% of study participants. Recognize the reality of operational, regulatory, and other constraints.
• Get input from a range of stakeholders. Before devising a solution, conduct market research and listen to participants, sites, healthcare professionals, advocacy groups, etc. The feedback can be beneficial for informing the solution’s ultimate structure.
• Start small. Success is more likely when initiatives start small and broaden with time and experience. Choose the first iPDR areas based on organizational structure and priorities — perhaps begin with a particular phased study, a specific therapeutic area, or a specific country. Pfizer, for example, intentionally launched with just two pilot studies, both in the same therapeutic area and only in the U.S.
• Gather ongoing feedback from participants. Consider posting an anonymous survey on study portals to ask participants what’s working, what’s not working, and what they want to see. Such intelligence can be used to refine iPDR solutions continually.

Advancing iPDR Together

Enabling meaningful and compliant iPDR options may help sponsor organizations establish more trust in clinical research, facilitate better partnerships with patient care networks, and improve participants’ potential clinical care decisions. In doing so, iPDR can be one means of promoting health equity.

Although operationalizing iPDR is undoubtedly challenging, no barrier is insurmountable. A rich set of solutions — including TransCelerate’s iPDR Package — is available for anyone to use. All sponsors are encouraged to join the efforts to advance iPDR across the clinical research ecosystem. Through open conversations and collaborations, this worthwhile endeavor can be accomplished at scale.

About the Author:

Paula Boyles is the external clinical trial data-sharing program lead at Pfizer and a member of TransCelerate Biopharma Inc.’s Participant Data Return Initiative. She has 17 years’ experience at Pfizer in both the U.S. and the U.K. and offers extensive international experience delivering global solutions across the clinical, development, and regulatory arenas. She holds a Bachelor of Applied Science in Management Information Systems and Services from Buckinghamshire College of Brunel University, U.K.