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Discovery & Development Clinical Trials

Silent Data

Only about one in 10 drugs that enter clinical development will make it past regulators. An analysis from researchers at McGill University has revealed that most trial data for drugs that don’t make the grade are never published (1).

The study examined drug trials in three areas – cancer, cardiovascular and neurological diseases – between 2005 and 2009. While 75 percent of clinical trials for approved drugs were published, this falls to 37 percent for drugs that reached Phase III clinical development, but were not approved within 4.5 years.

“We expected to see a lot of nonpublication,” says study author Jonathan Kimmelman, “but we were frankly very surprised to discover that so large a fraction of trials for unapproved drugs are never shared with the broader scientific community through publication.”

These ‘lost’ data could be crucial to speeding up drug development, says Kimmelman. “These trials return all sorts of valuable information – including clues about how we might pursue other drug candidates. Researchers often do not appreciate that this information is vital for drug development and contributes to the evidence base of even validated medical practice. They also do not appreciate that nonpublication violates the ethical contract with subjects who participate in such studies.”

Recent years have seen some moves towards greater transparency for clinical data, with GlaxoSmithKline agreeing to make detailed clinical data available to researchers on request, and the EU passing new legislation to make reporting of all drug trials compulsory. “I think there are generalized trends towards greater data transparency in drug development,” says Kimmelman. “People know this is a problem, but there is so much farther to go.”

Kimmelman would like to see all trial results published in full, regardless of whether the results are disappointing. “Academic medical centers and ethics committees should demand that all trial protocols contain a statement committing to publication of results, regardless of whether they are exciting or conclusive. Public funders, too, can demand that all trials recruiting patients at centers receiving money from them are published.”

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  1. A. Hakala et al., “Accessibility Of Trial Reports For Drugs Stalling In Development: A Systematic Assessment Of Registered Trials”, BMJ 350, h1116 (2015).
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Stephanie Vine

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