Data from more than half of cancer trials underpinning drug approvals is not accessible, according to a shocking new study.
Of the 304 industry-sponsored clinical trials that provided data for 115 anti-cancer drugs approved by the FDA between 2011 and 2021, only 45 percent had publicly shared patient level data.
The study found that less than one-tenth of trials cited on product labels made individual patient data available.
Sharing individual patient data is important for studies that pool data from published trials to assess the balance of evidence for new and existing treatments.
"Pharmaceutical companies are not going to give this data to other pharmaceutical companies because of competition, so this work has to be done by independent researchers," said Natansh Modi, the study's author.
It cannot be done without the data and transparency.
Data sharing helps strengthen public trust in science by allowing researchers to make use of existing data, replicate research studies, and validation of published results.
During the COVID-19 Pandemic, rapid data sharing has been priceless and has helped inform public health responses.
Modi and colleagues found that a lot of pivotal cancer trials that support the FDA registration of modern anti-cancer medicines are unavailable to qualified researchers.
The FDA has approved new drugs and medical devices before.
Recently, its controversial decision to approve a new drug for Alzheimer's disease sparked an uproar from health professionals who claimed industry-led clinical trials had not yet shown the therapy would slow memory loss or cognitive decline.
If an innovative new drug is considered safe and the need for improved treatments for a given disease is considered great, the FDA may approve it.
Although there are many reasons why clinical trial investigators might hold off sharing data from individual trials, the researchers behind this new study argue that the general public expects greater transparency from the billion-dollar pharmaceutical industry.
Long-term follow-up of study participants was the most common reason industry sponsors did not share trial data.
The release of the key data that is implicated in the global release of medicines to tens of thousands of people should not be hampered by ongoing follow-up.
In the case of ivermectin, flawed studies were allowed to slip through the cracks and skew the results of data-crunching, sense-making because researchers couldn't analyse raw data.
A poorly scrutinized evidence base supported the administration of millions of doses of a potentially ineffective drug globally and yet when this evidence was subjected to a very basic numerical scrutiny it collapsed in a matter of weeks.
Modi,Hopkins, and colleagues are calling for greater data transparency on pivotal trials to protect and maximize public health and ensure the contributions of trial participants and their families reach their full potential
The data can't be put to good use if it isn't made available.
Recent years have seen the introduction of policies to require or mandate data sharing among researchers. The American and European pharmaceutical associations shared trial data when requested.
It appears that issues of data transparency persist at a time when public trust in science is needed more than ever.
There was a study published.
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