Despite a 2014 commitment from the pharmaceutical industry to improve data transparency, more than half of the clinical trials leading to US Food and Drug Administration-approved anti-cancer medicines are not available for independent scrutiny, reported a Flinders University study.
Published in JAMA Oncology, the study found that of the 304 trials of 115 anticancer drugs in the last 10 years, only 136 (45%) had individual patient data available for sharing. For Australia’s most expensive chemotherapy drugs, 90% of the trial data was unavailable. Senior author Dr Ash Hopkins said collection of long-term follow-up data being ongoing was the most common reason provided for the lack of transparency. “However, this excuse disregards any commitment to data transparency. Ongoing follow-up is of course needed, but it should not hinder the release of the key data that is implicated in the global release of medicines to tens of thousands of people.”
The research team called on the pharmaceutical industry to explicitly state in their transparency policies that trial data underpinning drug approvals would be made available for independent investigation as soon as a drug is registered. “It is time that global regulators, governments, and journals establish mandates for data transparency on all major trials investigating registered medicines,” said senior team member Natansh Modi. “Their purpose must be to protect and maximise public health and ensure the contributions of trial participants and their families reach their full potential.”
