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Tuesday, June 15, 2004

Biotech - Full-disclosure of clinical trials?

The NY Times had an interesting front page story today headlined "Medical Journals Weigh Plan for Full Drug-Trial Disclosure." Some quotes:

An organization of top medical journals is considering a proposal that would require drug makers to register clinical trials at their start in a public database in order for results, whether successful or not, to be later considered for publication, according to three people working with the group.

Pharmaceutical companies are not generally required now to disclose results of a trial or even whether one was conducted. Some academic researchers have long argued that fuller registries of drug trials are needed because companies, as well as medical journals and scientists, tend to spotlight only trials that show positive results.

The plan, if adopted by the organization, the International Committee of Medical Journal Editors, is likely to put pressure on pharmaceutical makers to disclose more about the trials they run. The group includes 12 major medical journals like The Journal of the American Medical Association, The New England Journal of Medicine, The Lancet and The Annals of Internal Medicine.

[Update 6/16/04] Today's Indianapolis Star has a related story that begins:
The American Medical Association, the largest U.S. medical trade organization, approved a measure Tuesday urging the United States to require pharmaceutical companies to disclose all drug-study results, including negative findings. The AMA wants the government to create a database through which doctors and patients can view data on all human drug trials.

Posted by Marcia Oddi on June 15, 2004 09:22 PM
Posted to Biotech