Trials and Tribulations - Pharmaceutical Executive

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Trials and Tribulations
A furor over clinical data jeopardizes pediatric exclusivity provisos.


Pharmaceutical Executive


Registration Drive While PhRMA's initiative aims to expand disclosure of clinical trial results, FDA's ClinicalTrials.gov/. website, mandated by the FDA Modernization Act, provides a basis for registering and tracking human studies when they begin enrollment. Sponsors are required to describe the purpose of each qualifying experimental drug entering Phase II plus enrollment criteria, site locations, and point of contact.

But the site has not achieved its goals. (See "Better Late Than Never,") The failure of many companies to provide information on hundreds of eligible studies is driving efforts to strengthen the program. One idea is to have FDA post information about clinical studies on the database by extracting relevant data from investigational new drug applications (INDs). Some critics—not FDA officials or patient advocates—want to impose clinical holds or delay approvals for unlisted products.

In September, the International Committee of Medical Journal Editors, a group of 11 publications including the Journal of the American Medical Association, the New England Journal of Medicine, and Lancet, offered a new inducement. Effective July 2005, these journals will publish articles on drug trials only if the subject studies were previously listed on a public, non-profit site by the onset of patient enrollment. The editors regard comprehensive public listing of human subject studies as a necessary first step toward disclosure of research, whatever the results.

Volunteer—or What? The most direct way for Congress to encourage complete disclosure of clinical trials data would be through FDA. But that would require new legislation.

Pharma companies filing new drug applications are already required to submit all data from all clinical studies. Much of the information is proprietary, though, and never disclosed. The Best Pharmaceuticals for Children Act of 2002 gave FDA authority to post summaries of pediatric trials, including studies that fail to lead to approved labeling. But it does not apply to adult studies. FDA issues its own review of clinical data when it approves a new drug. But the results of research that FDA never approves do not reach the medical community unless sponsors publish the data voluntarily.

Observers remain skeptical that the industry's voluntary efforts will fill the information gap. PhRMA says an independent third party will manage its research database, and according to vice-president Caroline Loew, top company executives have made an "extremely strong commitment" to the program. Manufacturers are meeting with the AMA, patient groups, and other parties to iron out specifics such as which trials should be registered and disclosed. One challenge for manufacturers will be providing information on off-label studies without promoting off-label uses. Another is listing information expeditiously despite frequent long delays in article publication.

PhRMA tried to impress upon legislators that its initiative will provide access to data immediately, while a legislative route could take years. BPCA will be up for renewal in 2007, along with FDA user fees. That gives the industry two years to carry out its registration and disclosure promises.


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