According to an alarming new study that examined more than 300 clinical trials supporting cancer drugs approved by the U.S. drug regulator over the past 10 years, data from more than half of the cancer trials that underpinned the drug’s approval remain unavailable.
Of the 304 industry-sponsored clinical trials that included data on 115 cancer drugs approved by the US Food and Drug Administration (FDA) between 2011 and 2021, only 45 percent publicly shared patient-level data — or said they would. When researchers ask about access to data.
The study found that less than a tenth of the trials listed on the product labels of three of the top-selling cancer drugs made personal patient data available.
Sharing anonymized personal patient data—in secure data portals and to protect participant privacy—is essential for studies called meta-analyses, which combine data from published trials to assess the balance of evidence for new and existing treatments.
“Pharmaceutical companies don’t share this information with other pharmaceutical companies because of competition, so independent researchers have to do this,” said Flinders University pharmacist and study author Nathansh Mody. The Guardian.
“But it can’t be done without data and transparency.”
In addition to meta-analysis, data sharing allows researchers to use existing data, replicate studies, and confirm published results—all of which help build public trust in science.
It goes without saying that rapid information sharing has been invaluable during the COVID-19 pandemic, informing public health responses and accelerating research, treatments and vaccines.
“However, improvements have been made [individual patient data] transparency over the past five years, these findings indicate that a significant portion of the key oncology trials that support FDA registration of modern cancer drugs are not available to qualified investigators,” write Modi and colleagues.
This, of course, is not the first time the US FDA has come under scrutiny for approving new drugs and medical devices.
Recently, his controversial decision to approve a new Alzheimer’s drug has sparked outrage from medical experts who say industry clinical trials have yet to show the antibody therapy — now on the market for about $56,000 a year — slows memory loss or cognitive decline.
A drug is approved through the FDA’s accelerated approval pathway, in which if an innovative new drug is deemed safe and the therapeutic need for an improved treatment of the disease is deemed great, the agency may approve it based on limited evidence (although pharmaceutical companies may need to provide more information about real-world efficacy studies after a while). ).
While there are many reasons why clinical trial investigators may not share data from individual trials, the researchers behind this new study argue that the general public expects more transparency from the multibillion-dollar pharmaceutical industry. ensure the safety and efficacy 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.
“Of course, ongoing surveillance is necessary, but it shouldn’t prevent the release of key information about the global distribution of drugs to tens of thousands of people,” says Ashley Hopkins, a pharmacist and study author. Flinders University.
With summary-level data from trials, meta-analyses are inherently unreliable because researchers cannot interrogate the raw data, which, as was the case with ivermectin, may inadvertently allow erroneous studies to slip through the cracks and distort the results of data crunching. , sensory meta-analyses.
“A poorly reviewed evidence base supported the use of ineffective drug doses around the world, but when this evidence was subjected to very simple quantitative testing, it collapsed within weeks,” wrote Jack Lawrence and four colleagues. Nature Medicine After discovering the flaws.
Based on their research, Mody, Hopkins, and colleagues call for information disclosure on major trials to “protect and maximize public health and reach the full potential of the contributions of trial participants and their families.”
“If data is not available, it cannot be put to good use,” adds Modi.
In recent years, scientific journals and research funding bodies have introduced policies requiring or mandating information sharing among researchers. In 2014, the American and European pharmaceutical associations also committed to sharing anonymized trial data upon request.
While some researchers report a marked shift in researchers’ willingness to share data during the pandemic, data transparency issues appear to persist at a time when public trust in science is needed more than ever.
The study was published JAMA Oncology.