Did the study work? Consumers can find out
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Many of the most promising new medical treatments are just beyond the grasp of consumers simply because they don’t know about them. But that’s about to change. Beginning tomorrow, the nation’s database for clinical trials, www.ClinicalTrials.gov, will begin adding the results of trials of drugs, medical devices and biologic products (such as vaccines) conducted in the United States.
ClinicalTrials.gov was launched in 2000 to provide people with easy access to information about clinical trials. But until now, consumers who went to the website could find only details about the trial’s launch, such as the study’s design and who is eligible to enroll. Under the new rule, researchers sponsoring the trial must go back and post their results (except for very early-stage experiments, which are called Phase 1 trials) online within one year of the study’s conclusion or within 30 days of approval of a product by the Food and Drug Administration. The database will carry results of trials that were underway as of Sept. 27, 2007. However, researchers of previously completed trials have been encouraged to post their results, too.
The rule is a result of a law passed last year to demand more transparency in clinical trials. Consumer health advocates hope the requirement will make it harder for study sponsors to hide unexpected or harmful reactions to drugs or devices. In the past, consumers could only turn to medical and scientific journals to find out a study’s results. If the study wasn’t published, which sometimes happens especially if the trial failed, no one knew. Some pharmaceutical companies have been accused of hiding the results of studies, such as the side effects that were discovered with the arthritis medication Vioxx that was removed from the market in 2004.
‘Providing scientists, physicians and the public with results information could go a long way toward improving safety,’ said Dr. Elias Zerhouni, director of the National Institutes of Health, which operates the 62,000-study database.
Questions remain about how useful the database will be to the average person, however. Study results that are published in journals have been vetted by independent researchers and receive the attention of experts and the media, which foster discussion on the merits of the study and its findings. But simply posting the results of the study, without interpretation, may be of little help. Researchers will not be able to post their opinions or comments about the study.
-- Shari Roan
* An earlier version of this story incorrectly listed the Web address as ClinicalTrials.com.