Merck & Co. says it supports creation of an industrywide clinical-trial database. But Merck proposes that summarized results of clinical trials be added to such a database when they're made public at medical conferences and for detailed trial results be released at the same time they're published in medical journals, a spokeswoman says.
Proponents of clinical-trial registries say they would alert doctors and consumers to potential drug risks. But debate continues over how such a database would be managed and what information it should include. Some industry execs say such a database could disclose trade secrets and overwhelm consumers with complex information.
The American Medical Association has issued a call for the Department of Health and Human Services to establish a clinical-trial registry. The move is a response to the ongoing debate over whether pharmaceutical companies should publicly disclose negative clinical-trial results. Earlier this month, New York Attorney General Eliot Spitzer sued GlaxoSmithKline, charging that the drugmaker withheld information about adverse effects of its Paxil antidepressant drug on teenagers. "We're suggesting having a single database where every trial gets registered," says Dr. Joseph Heyman, an AMA trustee.
Generally, only information about trials with positive results get published today, while negative results aren't made public, Heyman says. And published results of drug trials sponsored by pharmaceutical makers tend to favor those companies' drugs. The lack of a comprehensive database also makes it difficult to compare test results between similar drugs, Heyman says. There's also debate over just what to include in a database. The AMA proposes including all clinical trial data, for example, while Merck favors including only data from late-stage trials.
No one seems to know how many clinical drug trials are conducted every year, but it's likely several thousand or more every year. In 2002, drug companies and the National Institutes of Health spent $5.6 billion on clinical trials, Heyman says.
The Pharmaceutical Research and Manufacturers of America, the industry's leading lobbying group, has not taken a formal position on the proposal. But such a database runs the risk of disclosing proprietary data about a company's development efforts, a group spokesman says.
The sheer volume of the data and its complexity could also be difficult for physicians and health-care consumers to decipher. "If there are 5,000 pages of data, it could be more confusing than helpful," the group's spokesman says. Drug-development efforts generally involve dozens of clinical trials, and negative results from a single trial might give doctors and patients a misleading picture of a drug's effectiveness or related safety issues, he says.
Some propose using an existing clinical-trial database operated by the National Library of Medicine, part of NIH, as the core for an expanded clinical-trial registry. The NLM system was created in the late '90s to alert people with serious and potentially life-threatening illnesses about experimental drug trials. NLM has gone beyond that mandate and added the results of nearly 11,000 trials, most sponsored by NIH and many still active, says Alexa McCray, NLM's biomedical communications director.
That site receives 14,000 to 16,000 visitors every day and presents some 2.5 million page views per month. McCray says there's no technical obstacle to expanding the database to cover all clinical trials. The issue, she says, is ensuring that adequate data quality safeguards are in place to prevent adding inaccurate or overstated data to the system. Says McCray, "Bad information is worse than no information."