Data from more than half of cancer trials that underpin drug approvals remain inaccessible, according to a shocking new study that audited more than 300 clinical trials supporting cancer drugs approved by the US drug regulator over the past few years. last 10 years.
Of the 304 industry-sponsored clinical trials that provided data for 115 cancer drugs approved by the US Food and Drug Administration (FDA) between 2011 and 2021, only 45% had publicly shared patient-level data – or had said they would when the researchers asked about data access.
Additionally, less than a tenth of the trials cited on the product labels of three of the top-selling cancer drugs made individual patient data available, according to the study.
Sharing anonymized individual patient data – in secure, anonymized data portals to protect participant privacy – is essential for studies known as meta-analyses that pool data from published trials to assess the balance of evidence for new and existing treatments.
“Pharmaceutical companies will not provide this data to other pharmaceutical companies due to competition, so this work must be done by independent researchers,” said pharmacist and study author Natansh Modi of Flinders University. . The Guardian.
“But that can’t happen without data and transparency.”
Besides meta-analyses, data sharing also allows researchers to use existing data, replicate research studies, and validate published results, which helps build public trust in science.
And it almost goes without saying that the rapid sharing of data has been invaluable during the COVID-19 pandemic, informing public health responses and accelerating research, treatments and vaccines.
“Although progress has been made to improve [individual patient data] transparency over the past five years, these results suggest that a significant portion of pivotal oncology trials that support FDA registration of modern cancer drugs remain inaccessible to trained researchers,” Modi and colleagues write.
This is certainly not the first time that the US FDA, which approves new drugs and medical devices, has come under scrutiny.
Recently, his controversial decision to approve a new drug for Alzheimer’s disease sparked an outcry from medical professionals who claimed that industry-led clinical trials had yet to show that the therapy by antibody – currently on the market for around US$56,000 a year – would slow memory loss or cognitive decline.
The drug had been approved through the FDA’s fast track approval pathway whereby if an innovative new drug is considered safe and the therapeutic need for improved treatments for a given disease is considered significant, the agency may approve based on limited evidence (although pharmaceutical companies should provide more efficacy data from real studies soon after).
While there are many reasons why clinical trial investigators might delay sharing data from individual trials, the researchers behind this new study say the general public expects greater transparency. from the billion-dollar pharmaceutical industry that has a responsibility, along with drug regulators, to ensure the safety and effectiveness of new drugs.
The most common reason industry sponsors did not share trial data was that long-term follow-up of study participants was ongoing, according to the study.
“Continued tracking is, of course, necessary, but it should not impede the release of key data implicated in the global delivery of drugs to tens of thousands of people,” says pharmacist and study author Ashley Hopkins, also from Flinders University.
With only summary data from trials, meta-analyses are inherently unreliable because researchers cannot interrogate the raw data, which could, as was the case with ivermectin, leave inadvertently passing erroneous studies and distorting the results of data analysis. , sensible meta-analyses.
“A poorly reviewed evidence base supported the administration of millions of doses of a potentially ineffective drug on a global scale, and yet when that evidence was subjected to very basic numerical scrutiny, it crumbled in a matter of seconds. weeks,” Jack Lawrence and four colleagues wrote in natural medicine after exposing the flawed studies.
Based on their study, Modi, Hopkins and colleagues call for greater data transparency on pivotal trials “to protect and maximize public health and ensure that the contributions of trial participants and their families reach their full potential.” “.
“If the data is not made available, it cannot be put to good use,” Modi adds.
In recent years, scientific journals and research funding organizations have introduced policies to require or mandate data sharing between researchers. In 2014, the American and European pharmaceutical associations also committed to sharing anonymized trial data upon request.
Although some researchers have reported a noticeable shift in their intentions to share data during the pandemic, it appears data transparency issues persist – at a time when public trust in science is needed more than ever.
The study was published in JAMA Oncology.