Study finds gaps in clinical trial data transparency for top medicines
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A study by Flinders University has highlighted both progress and persistent gaps in the transparency of clinical trial data for top-selling medicines, urging pharmaceutical companies to improve access to critical information.
The findings, published in the journal Clinical Trials, underline the importance of independent review and data accessibility to enhance trust and collaboration in the pharmaceutical sector.
“Over the past decade, there has been a notable emphasis by pharmaceutical companies, advocacy groups, and regulatory bodies on the importance of sharing data from clinical trials to validate research findings, enhance scientific collaboration, and foster trust in the pharmaceutical industry,” said study lead author Dr Natansh Modi.
The audit evaluated 316 trials supporting Food and Drug Administration (FDA) approval for the 30 highest-revenue medicines of 2021. It revealed that 64% of trials made data accessible for independent researchers, representing a marked improvement compared to earlier assessments in other fields. However, 32% were deemed ineligible for sharing, and 4% required full research proposals to determine eligibility.
Dr Modi pointed to the increasing use of independent platforms by pharmaceutical companies as a driver of higher data-sharing rates.
“Companies using independent, external platforms for data sharing achieved higher eligibility rates than those relying on internal processes,” he said. “This finding aligns with calls for standardised data-sharing practices and suggests that third-party management of data-sharing platforms could further enhance transparency and reduce potential conflicts of interest.”
While the results indicate progress, challenges remain. Trials still labeled as “ongoing” were significantly less likely to share data, even when these trials were pivotal for product approval.
“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,” Dr Modi added.
The study’s authors stressed the ethical importance of sharing clinical trial data, given the role it plays in validating the safety and efficacy of 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 senior author Associate Professor Ash Hopkins, leader of the Clinical Cancer Epidemiology Lab.
The research underscores the need for pharmaceutical companies to adopt standardised practices and employ third-party platforms to increase transparency and foster trust in the industry.
“This could ultimately foster greater trust in the pharmaceutical industry, benefiting researchers and patients alike,” said Dr Modi.
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Ritchelle is a Content Producer for Healthcare Channel, Australia’s premier resource of information for healthcare.
