Drug companies agree to make clinical trial results public
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《英国医生杂志》
Pharmaceutical companies around the world have agreed to make results from clinical trials of new prescription medicines publicly available, it was announced last week.
The voluntary agreement has been drawn up by the world's main pharmaceutical industry trade associations and agreed by key companies. It states that summary results of completed, industry sponsored clinical trials will be publicly disclosed on free and publicly accessible databases, regardless of outcome, for any medicine approved for marketing in at least one country.
The results will be published in a standard, non-promotional summary that will include a description of trial design and methods, results of primary and secondary outcome measures described in the protocol, and safety results. Each company can select the website where they publish trial results, but if they are published in a peer reviewed journal, the database will include a link to the relevant article.
For medicines not yet approved or for trials not yet completed, companies agreed that the results should normally be published within one year of approval or, for post-approval trials, within one year of trial completion. In addition, details of all clinical trials, other than exploratory trials, will be publicly registered within 21 days of starting patient enrolment, with information on how to enrol for patients and clinicians.
The agreement says that the pharmaceutical industry is "committed to increasing the transparency of the clinical trials our member companies sponsor."
Four key international pharmaceutical associations, including the European Federation of Pharmaceutical Industries and Associations, and the Pharmaceutical Research and Manufacturers of America, signed up to the agreement, which will be adopted later this year.
The agreement follows several serious problems with prescription medicines associated with lack of open access to clinical trial results—including the increased risk of cardiovascular deaths resulting in the recent withdrawal of rofecoxib ( BMJ 2004;329: 816).
Wendy Garlick, principal policy adviser in health to Which?, a UK consumer organisation and publisher of Drug and Therapeutics Bulletin, said, "We support the agreement but consider that it should be mandatory—enforced by legislation—and not voluntary."(Susan Mayor)
The voluntary agreement has been drawn up by the world's main pharmaceutical industry trade associations and agreed by key companies. It states that summary results of completed, industry sponsored clinical trials will be publicly disclosed on free and publicly accessible databases, regardless of outcome, for any medicine approved for marketing in at least one country.
The results will be published in a standard, non-promotional summary that will include a description of trial design and methods, results of primary and secondary outcome measures described in the protocol, and safety results. Each company can select the website where they publish trial results, but if they are published in a peer reviewed journal, the database will include a link to the relevant article.
For medicines not yet approved or for trials not yet completed, companies agreed that the results should normally be published within one year of approval or, for post-approval trials, within one year of trial completion. In addition, details of all clinical trials, other than exploratory trials, will be publicly registered within 21 days of starting patient enrolment, with information on how to enrol for patients and clinicians.
The agreement says that the pharmaceutical industry is "committed to increasing the transparency of the clinical trials our member companies sponsor."
Four key international pharmaceutical associations, including the European Federation of Pharmaceutical Industries and Associations, and the Pharmaceutical Research and Manufacturers of America, signed up to the agreement, which will be adopted later this year.
The agreement follows several serious problems with prescription medicines associated with lack of open access to clinical trial results—including the increased risk of cardiovascular deaths resulting in the recent withdrawal of rofecoxib ( BMJ 2004;329: 816).
Wendy Garlick, principal policy adviser in health to Which?, a UK consumer organisation and publisher of Drug and Therapeutics Bulletin, said, "We support the agreement but consider that it should be mandatory—enforced by legislation—and not voluntary."(Susan Mayor)