4 Steps To Help Sponsors Return Individual Patient Data

By Jessica Scott, MD, JD, CEO, and Jennifer Millman, JD, senior director of strategy and operations, Legacy Health Strategies

In part one of this series, we explored the concept of returning individual patient data to clinical trial participants, emphasizing its ethical importance and the challenges it presents. We discussed how this practice aligns with foundational principles of research ethics, respects participant autonomy, and promotes transparency in the research process. We also examined the growing expectations across the ecosystem toward participants as active partners in clinical trials helping to advance science and patient care.

Building on this foundation, part two delves into the practical aspects of implementing patient data return. Herein, we outline key strategies for sponsors to consider as they develop and execute plans for responsibly sharing individual results with participants.  

How Sponsors Should Think About Patient Data Return

It is not intended to be a one-size-fits-all approach or solution. Proactive, quality, risk-based planning for individual data return helps to demonstrate respect for individual autonomy and the contributions and preferences of the participant and as such may increase the level of meaningful engagement with participants, improve participant experiences, and enhance the relationship between stakeholders involved across the research and healthcare ecosystems.¹

Four key areas sponsors should focus on to ensure the responsible return of data to patients in alignment with the above foundational documents include:

1. Clear communication and interpretation of complex research results: Returning data with proper explanation and context helps participants accurately understand and interpret the results, reducing the risk of unnecessary anxiety or harm, especially when results are unexpected or difficult to understand. Depending on the data and information being shared, sponsors should consider whether and how to incorporate trial investigators, healthcare practitioners, and/or genetic counseling consultation.
2. Respecting confidentiality, privacy, and autonomy: Returning data responsibly requires implementing appropriate confidentiality and privacy measures to protect participants' personal information. Sponsors should adhere to strict data protection laws and obtain informed consent from participants regarding the handling and sharing of their individual results. Moreover, while the majority of participants indicate interest in receiving individual results, the autonomy of decision-making requires that participants have the opportunity both to decline to receive results and to change their decision as their trial participation ends.
3. Responsible communication to prevent unethical promotion of unapproved treatments or therapies: Returning data responsibly involves clearly communicating the limitations and uncertainties of research findings to prevent inadvertent promotion and even the perception of promotion of unapproved treatments or therapies.
4. Establishing an enterprise-wide policy for consistency: Developing and implementing an enterprise-wide policy ensures consistent application of ethical principles across all programs. This policy should provide clear guidelines on the return of data, helping to maintain consistent application as to what can be shared, how, and when, while taking into account specific considerations for each clinical trial and program.

4 Steps To Begin Patient Data Return

Developing guideposts recognizes that, while decisions regarding individual results return may vary from one trial to the next, there is a set of principles that remains consistent and relevant to any situation as one develops a robust data return plan.²

Four strategies to align implementation with the ethical principles put forth in the foundational documents:

1. Build a comprehensive business case: With key internal stakeholders, develop a compelling argument that aligns the return of individual participant data with ethical principles, evolving trends, and regulations. Highlight how this practice supports organizational priorities, enhances enrollment and retention, and strengthens patient engagement.
2. Prioritize patient engagement: Plan for the return of individual data with all key external stakeholders impacted by its return. Consult patients, care partners, and other community stakeholders in the early process of determining what may or may not be meaningful to clinical study participants. This collaborative approach ensures that the return of individual results is guided by the perspectives and needs of the participants themselves, fostering a more patient-centric and ethically grounded research process. By engaging patients and other stakeholders early on, sponsors can better align their practices with the principles of respect for persons, beneficence, and justice, while also promoting trust and transparency in the research enterprise.
3. Integrate return of data into protocol development: Sponsors should consider the return of individual results during the protocol development phase. This ensures that return of data practices are reviewed and approved by all governing bodies, including the IRB, from the outset, aligning with ethical principles and regulatory requirements. Early integration helps in planning and resource allocation for effective implementation. Use this as an opportunity to create a robust plan, involve key stakeholder groups, and communicate clearly with participants.
4. Take the first step in alignment with emerging good practices: Start with a simple approach, establish a clear process, and learn from the experience to build a robust program for returning results throughout the organization over time. As an initial step, consider returning individual results after the study has ended. This is a great time to involve digital platforms for ongoing engagement with participants, even after the study has ended and site contracts have concluded. Such platforms ensure continuous communication and seamlessly facilitate the responsible return of individual results.

It is time to prioritize the ethical return of individual results to clinical trial participants. We can no longer ignore this imperative that aligns with our foundational principles and the clear desire of patients. The good news is that we have the necessary guidance and practical models to make it happen, with real-world experience and shared approaches paving the way. By integrating patient perspectives, embedding return practices in protocols, building robust business cases, and embracing best practices, we can respect participants as active partners and advance a more equitable, participant-centered paradigm in an evolving landscape of transparency and engagement. It's time to honor our participants' contributions, fulfill our moral obligations, and demonstrate that the complexity of implementation is no longer an acceptable excuse – we've got this.

References:

1. TransCelerate BioPharma Inc. 2023. Individual Participant Data Return (iPDR) Considerations Guide. p. 4.
2. Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center). 2017. Return of Individual Results to Participants Recommendations Document, Version 1.2. P.18

About The Authors:

Jessica Scott, MD, JD, is the CEO of Legacy Health Strategies, where she brings a unique blend of expertise as a physician, attorney, and former pharmaceutical executive to drive patient-centered solutions. Inspired by the loss of her sister to osteosarcoma, Jessica has dedicated her career to improving patient outcomes and experiences. Her background includes a decade as a family medicine physician, legal experience in healthcare, and executive roles at GlaxoSmithKline and Takeda, where she successfully integrated patient perspectives into global program teams. An award-winning leader in patient engagement, Jessica is recognized for her work in clinical trial transparency and developing patient-centered approaches in drug development. She serves as a strategic advisor to various organizations and is committed to transforming the healthcare industry by fostering collaboration between patients, healthcare providers, and pharmaceutical companies. Married with three children, Jessica exemplifies how personal loss can drive positive change in making healthcare more inclusive and compassionate.

Jennifer Millman, JD, is the senior director of strategy & operations at Legacy Health Strategies, where she leverages her diverse background to accelerate awareness and access to clinical trials through equity-centered engagement. Prior to joining Legacy, Jennifer transitioned from a successful 14-year legal career to the non-profit sector, where she led a women’s leadership program and managed a foundation focused on community grantmaking. This experience honed her skills in strategic thinking and passion for mission-driven work, which she now applies to bridging the gap between clinical research and the patients it aims to serve. Together with her husband, she has raised two children in the vibrant Baltimore community that shaped her own upbringing.