While substantial progress has been made in sharing data from clinical trials, many top-selling medicines still fall short when it comes to making data publicly accessible, according to new Flinders University research.
Study lead author Dr Natansh Modi, a research associate in the Clinical Cancer Epidemiology Lab at Flinders University, says that clinical trials are essential for determining the safety and efficacy of new medicines.
"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, enhancing scientific collaboration and fostering trust in the pharmaceutical industry," says Dr Modi.
"A growing proportion of pharmaceutical companies now have Individual Participant Data (IPD) – sharing policies, with evidence of increased data sharing rates, particularly following the adoption of independent platforms.
"However, significant challenges remain, including the issue of data accessibility for trials contributing to product approvals.
"Specifically, 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 says.
Published in the journal Clinical Trials, the researchers evaluated the IPD-sharing for each trial that supported Food and Drug Administration (FDA) approval for the 30 highest-revenue medicines for 2021.
The audit found 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.
"Our findings show that there is a growing trend towards data sharing, revealing substantial progress in the transparency of clinical trial data for the highest revenue-generating medicines," he says.
"In particular, 64 per cent of the trials supporting FDA approval of the top 30 medicines in 2021 were eligible for independent data access – a marked improvement compared to prior assessments in other fields, where eligibility rates were notably lower.
"This progress highlights a growing commitment in the pharmaceutical industry toward making clinical trial data more accessible."
Importantly, the study indicated a higher rate of data sharing among companies that employed independent platforms to manage the process, while ongoing trials were significantly less likely to provide access to their data.
"Companies using independent, external platforms for data sharing achieved higher eligibility rates than those relying on internal processes," says Dr Modi.
"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.
"This could ultimately foster greater trust in the pharmaceutical industry, benefiting researchers and patients alike."
Senior author Associate Professor Ash Hopkins, an NHMRC Investigator and leader of the Clinical Cancer Epidemiology Lab, says that their findings highlight the need for pharmaceutical companies to make clinical trial data accessible and beneficial for independent research.
"It is important that individual participant data be made readily available, especially given the critical role clinical trials play in confirming the safety and efficacy of new medicines," says Associate Professor Hopkins.
"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," he says.
The paper, 'The state of individual participant data sharing for the highest-revenue medicines by Natansh D Modi, Lee X Li, Jessica M Logan, Michael D Wiese, Ahmad Y Abuhelwa, Ross A McKinnon, Andrew Rowland, Michael J Sorich and Ashley M Hopkins was published in Clinical Trials. DOI: 10.1177/17407745241286147
Acknowledgements: N.D.M. is supported by a Postgraduate Scholarship from the National Health and Medical Research Council, Australia (APP2005294). A.M.H. is supported by an Emerging Leader Investigator Grant from the National Health and Medical Research Council, Australia (APP2008119). M.J.S. is supported by a Beat Cancer Research Fellowship from Cancer Council South Australia.
