Demystifying Individual Participant Data Return

Dec 20, 2023 | Legacy News

On 17 October, 2023, Johanna Blom, Coordinator of FACILITATE, Véronique Poinsot, Project Leader of FACILITATE and Swapna Pothula, member of the TransCelerate initiative, participated at Scope EU Congress in Barcelona, in a panel entitled “Demystifying Individual Participant Data Return to Modernize and Personalize Clinical Trials”.

This panel discussion with several speakers aimed to:

  • raise awareness of solutions designed to facilitate individual participant data return
  • identify opportunities to demystify and build trusted alliances between all stakeholders involved in patient-centred drug development
  • highlight the cultural shift and operational strategies being supported by cross-industry collaborations to maximize impact
  • provide a proactive approach to enabling individual participant data return across the ecosystem.

Clinical trial participants would like more data returned to them during and after trial participation in clinical trials. However, the frequency, timing and type of data returned to participants varies today and is not widespread.

“Enabling meaningful participant data return options helps to establish trust in the research enterprise, facilitates partnerships, and supports ownership of an individual’s data in making future care decisions”

stated Véronique Poinsot.

“Work has been done to support sponsors in returning participant data – continued Johanna Blom – but there is still uncertainty about how, when and what types of participant data can be returned in a meaningful, secure, and safe manner while maintaining scientific integrity and submission timelines for approval remains”.

Many global stakeholders are seeking to develop solutions for patients and study participants who wish to become better-informed decision makers when it comes to their treatment options, including clinical trials as a potential option.

All support this important development:

  • growing interest in accessing health data and active participation in research
  • the growing gap in data sharing practices between clinical care and clinical research
  • recogniting the value of participant contributions to the development of new and innovative treatments
  • secure data platforms that offer opportunities for the exchange of multidimensional health data
  • the wider use of portals, patient-centred apps and wearables.

In conclusion, the speakers gave examples of their current solutions, the move towards a more patient-centric future and suggested opportunities for further collaboration to accelerate the development of personalised data return models for individual participants.

“This panel – commented Swapna Pothula – offered to audience the opportunity of increasing awareness on the shift in perspective of the patient and the value of their individual data throughout the drug development process and how executive leadership commitment to cultural change will be required to optimize meaningful, flexible, personalized clinical trial options, build trust and improve patient experiences and outcomes”.



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