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Pharmaceutical industry groups agree to disclose clinical trial information
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Trade groups representing the international pharmaceutical industry are proposing to disclose information on clinical trials to the public through free Internet sites beginning this year.
The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) developed the principles of disclosure in collaboration with trade groups in Europe, Japan and the United States, according to a press release from the international group
“The industry recognizes that there are important public health benefits, including increased confidence, associated with making clinical trial information more widely available to health care practitioners, patients and others,” said Harvey E. Bales, MD, director general of IFPMA, in a message on the group’s Web site.
The IFPMA has proposed two types of disclosure, both Internet-based. Clinical trials in progress will from their outset be listed in an online clinical trial registry that describes the study and its endpoints. Completed clinical trials will have their results published in an online database, according to the IFPMA.
Under the proposal, phase 1 study results would be exempt, and companies would be under no obligation to reveal the results of a study before a drug is approved.
According to IFPMA, trial results will be published in a standard, non-promotional summary that will include a description of the trial design and methodology as well as results of primary and secondary outcome measures. If trial results are published in peer-reviewed journals, the summaries will be linked to them as well, the group noted.
“By publishing not just the results of trials that have taken place — whether positive or negative — but also those that are just starting, the industry has made a major step towards achieving greater transparency,” said Richard Barker, MD, director general of the Association of the British Pharmaceutical Industry, on the group’s Web site.
Trial results should be published within 1 year after a medicine has been approved, or, if the medicine has already been approved, within 1 year of trial completion.
In the United States, The Pharmaceutical Research and Manufacturers of America, is recommending that its members post study results on the government-run Web site, www.clinicaltrials.gov, beginning July 1. Pharmaceutical companies are already required to post trials dealing with serious or life-threatening diseases to the government site, the group said.
Drug companies’ responses to the new disclosure system varied, according to an Associated Press report. AstraZeneca, for instance, said it did not want to disclose proprietary information; Merck & Co. said it has been publishing results of late-stage clinical trials but it will now begin posting mid-stage trial information as well, the AP report stated.
GlaxoSmithKline reported last year that it would begin posting results of trials on an internal Web site as well as on a U.S. government-run Web site. That company was sued by the Attorney General of New York for allegedly hiding results from a trial of one of the company’s anti-depressant drugs.