A study just published in the journal BMJ Open shows that the results of many drug trials are never publicly reported.
The Washington Post reports that about one third of such trials— used as the basis for new drug approval—are not published. The authors of the article are pushing for all trial results to be made public to give physicians more information for their treatment decisions.
In their study, the researchers graded drug companies on their transparency in reporting about drug trials, according to the Post. The research team examined thousands of pages of regulatory documents, and counted up the number of trials Food and Drug Administration (FDA) regulators reviewed, versus how many trials were published or publicly reported. This first transparency report card showed how much evidence was made publicly available about how 15 drugs approved in 2012 work in people.
Jennifer Miller, an assistant professor of medical ethics at New York University School of Medicine, led the study, the Post reports. Miller said all evidence from drug trials is important: “If the public evidence is partial or biased you risk having partial or biased [prescribing] guidelines,” she said.
The report card the researchers presented in the study gave each company a transparency grade based on what percentage of all trial results were made available, not just the ones required to be reported. Gilead’s HIV drug Stribild, received a grade of 21 percent. Of 34 trials presented to the FDA, 26 were never made public, according to the Post. Stivarga, Bayer’s colorectal cancer drug, got a grade of 47; seven of 12 trials were not made public. Pfizer scored 100 percent for its kidney cancer drug, Inlyta. The company made public all 28 trials it presented to the FDA.
The researchers note that they analyzed only a subset of drugs approved in 2012, and they did not look at evidence of how the drugs worked (or failed to work). The research was confined to whether clinical trials were registered with the FDA and reported, the Post says.
Clinical trials are generally conducted in three phases, with different goals in each phase. Phase III trials, the largest and most authoritative, are designed to test the safety and effectiveness of the drug. A late-stage trial meeting certain requirements is required to be registered and reported to the FDA. Only a small fraction of the trials identified in the BMJ Open study were among those required to be disclosed, but five drugs made by three companies were rated as zero percent compliant. Three of the 15 drugs studied had at least late-stage phase III trial that was not publicly available.
The nonprofit organization Bioethics International, which is funded by foundations and universities but not pharmaceutical companies, plans to issue drug company transparency report cards every year. The researchers hope their “Good Pharma Scorecard” will serve as an incentive for companies to be more transparent.
When evidence is withheld, the researchers say, it is more difficult for physicians to know how a drug works on patients. Unreported trials—often those with inconclusive or negative findings—may contain information useful for physicians. Sometimes a drug that is not widely effective works well for a portion of the population or in limited circumstances.