New research from Flinders University indicates that while progress has been made in sharing data from clinical trials, significant challenges persist, particularly regarding data accessibility for trials contributing to product approvals. The study, published in the journal Clinical Trials, evaluated the Individual Participant Data (IPD)-sharing policies for each trial that supported Food and Drug Administration (FDA) approval for the 30 highest-revenue medicines of 2021.
The audit revealed that of the 316 clinical trials conducted for the top-selling medicines, 201 trials (64%) had data accessible to researchers. However, 102 trials (32%) were confirmed ineligible, and 13 trials (4%) required a full research proposal before determining eligibility.
Independent Platforms Enhance Data Sharing
The study indicated a higher rate of data sharing among companies that employed independent platforms to manage the process. According to Dr. Natansh Modi, a research associate in the Clinical Cancer Epidemiology Lab at Flinders University, "Companies using independent, external platforms for data sharing achieved higher eligibility rates than those relying on internal processes." This finding suggests that third-party management of data sharing platforms could further enhance transparency and reduce potential conflicts of interest.
Ongoing Trials and Data Accessibility
The research also highlighted that ongoing trials were significantly less likely to provide access to their data. Dr. Modi emphasized that data from trials that are part of the product label should be accessible for independent review, even when ongoing follow-ups for secondary outcomes are in progress. "Labelling these trials as ‘ongoing’ should not preclude the sharing of data pivotal to approval," he stated.
The Importance of Data Sharing
Associate Professor Ash Hopkins, a senior author of the study, stressed the importance of making individual participant data readily available, especially given the critical role clinical trials play in confirming the safety and efficacy of new medicines. "We should honour the contributions of patients who have enrolled their clinical data and experiences into science because it is this data that helps to support advancements in medical science and patient care," said Hopkins.
The researchers concluded that while there is a growing trend towards data sharing and substantial progress in the transparency of clinical trial data, continued efforts are needed to improve data accessibility and foster greater trust in the pharmaceutical industry.
