Patient Data Return

The working group project team will create, disseminate, analyse a survey to Pharmaceutical companies on their clinical trial information and current processes regarding the results. The survey will form the basis of a white paper on the results.

Participant data return is the act of granting clinical trial participants access to the data that was collected about them during a clinical trial.  With the current clinical trial practice, measurements are taken, tests are run, procedures are done, and the results are seen by the investigator and hosted by the sponsor.  The participant, never sees their results.  Once the trial closes and participants wish to get on new medication, the results of their trial are not available to help make this decision.

Despite significant cross-industry collaboration on this topic by Trancelerate, MRCT, IMI, and EC the adoption of participant data return practices has been slow.  This project aims to highlight current industry practice and identify gaps and challenges.

Clinical Trial Sponsors are increasingly prioritising patient-centricity incorporation of the patient voice in drug development.  At the same time there is growing participant interest in being an active part of research and recognition of the value of the patient’s contribution to clinical research.  As health data becomes more commonplace, there is an increased expectation on sponsors to provide this information back to participants. 

The inability for participants to know and share their clinical trial data with their medical teams leads to delays and incomplete recommendations for their continued care.  Participant’s doctors cannot understand participant’s data during the clinical trial to make treatment recommendations.

Specifically to the implementation of PDR in Biopharma companies, lack of knowledge on the general prevailing opinion related to PDR causes each sponsor to create a solution for themselves.  This causes rework and delays in implementing solutions.