Introduction
Before a new drug finds its place on pharmacy shelves or a new device lands in the hands of a surgeon, it goes through a long and complex approval process by the U.S. Food and Drug Administration.
A new drug, for instance, goes through laboratory testing and animal studies before the drugmaker submits an application to FDA’s Center for Drug Evaluation and Research. If it gets the agency’s green light, then the human clinical trials begin, starting with a small number of participants at initial phases and growing to hundreds if not thousands of participants in the final phase. The results about how the drug works and its possible side effects are then submitted to FDA for final approval.
But can consumers search online to find the clinical trials data for a new drug prescribed by their doctors? And if other researchers want to examine the data, is it easily available?
The answer is, not really.
The neatly folded package insert with a medication includes a summary of the clinical trials data in tiny print. And sifting through numerous medical journals and publications might yield information about some clinical trials. But there is no centralized source for the data, said Merrill Goozner, a journalist who runs the respected drug and health policy blog, GoozNews on Health. And information about trial data on drugs and devices that failed FDA’s approval process is unlikely to be available anywhere.
Clinicians and advocates of data transparency, say that clinical trials data – successful or not – should be made public to help further scientific research. After all, they say, transparency is the cornerstone of science. “It’s about knowing what works, and what doesn’t,” said Goozner, who has been writing about the FDA and the drug industry for more than a decade. All clinical trials are currently registered with the U.S. National Institute of Health and some information about the types and numbers of ongoing trials is available at ClinicalTrials.gov.
The FDA has been working toward making more information about clinical trials, including results, available to the public. The U.S. Food and Drug Administration Amendments Act of 2007, which went into effect in September 2008, requires clinical trials results to be made available to public online, within a year of the trials’ completion. But it’s not clear when and how those results will become available to the public. A study published in the PLoS Medicine in 2008 showed that “over half of all supporting trials for FDA-approved drugs remained unpublished 5 years after approval.”
FDA officials were unavailable for comment.
Meanwhile, drug companies and device manufacturers prefer to keep unfavorable information from clinical trials shielded from public scrutiny. For instance, lobbyists “convinced Congress in 2007 to insert a last-minute provision in the Food and Drug Administration Amendments Act that allows medical device manufacturers to withhold data disclosure to a public government database, ClinicalTrials.gov, when their products fail to make it to the market,” reported the Sunlight Foundation in 2009.
Dr. David Gorski, a surgeon at the Barbara Ann Karmanos Cancer Institute, wrote about FDA and the transparency of clinical trial data for approved drugs back in 2008. “I honestly don’t know whether things have improved since then, but I don’t think they have,” he told the Center. “It’s important to know the results of all the trials. Results of any [trial] that has public funding has to be available somewhere. Anything that goes through the FDA process, too, has to be made available.”
ABOUT THE DATA
What: Clinical trials data and results for new drugs, biologics and devices
Where: U.S. Food and Drug Administration
Availability: Sporadic, not centralized, and mostly inaccessible
Format: N/A
Usability: N/A
The Data Mine is a joint project of the Center for Public Integrity and the Sunlight Foundation.
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