Individual data return is now reality
in the USA, participants to clinical trials can now have consistent and reliable access to their individual data through a Pfizer innovative initiative.
Pfizer has made a commitment to return individual data to its clinical trials participants through the Participant Data Return initiative, that allows participants at US sites to receive their data about 12 months following completion of the trial. These data include patient demographics, treatment arm, adverse events, primary outcome measure, medical history/conditions, procedures, medications, lab results, and vital signs.The process of patient data sharing started in the US pharmaceutical company in 2015, with the development of the platform PfizerClinicalTrialAlumni.com to enable participants to securely access, view, and download their aggregate results. Going through the creation of relevant materials for patient in the following years, in 2021 Pfizer created clinical trial results summaries in plain and understandable language, with non-technical descriptions of the design and results that include data across the entire study. Today, Pfizer is committing to return individual clinical trial data back to study participants, allowing them to make better decisions about their care in consultation with their healthcare providers.
Pfizer’s Participant Data Return initiative is part of a larger collaboration with other partners, including the IHI (Innovative Health Initiative) FACILITATE project, for the development of a new ethical, legal, and regulatory framework in Europe, overcoming the current limitations and discrepancies between European member states, to enable the return of clinical trial data to study participants.
To know more on Pfizer’s Participant Data Return initiative, read the article Pfizer To Provide Individual Participant Data At Scale by Aida Habtezion