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All the Data That Are Fit to Post
Private initiatives are also achieving the goal that Sens. Dodd and Kennedy want to legislate: registration of all clinical trials. In 2004 the International Committee of Medical Journal Editors (ICMJE) adopted a policy that requires, as a condition of consideration for publication in their journals, registration of clinical trials in a public registry. Trials beginning after July 1, 2005, must be registered at or before the onset of patient enrollment. The ICMJE established criteria that each trial must meet to insure transparency and required that the registry be accessible to the public free of charge. At the time, the only website that qualified was ClinicalTrials.gov, run by the United States National Library of Medicine.
The ICMJE policy has had an effect. After the policy was announced, the number of clinical trial registrations increased by 73 percent—from 13,153 to 22,714. As of April 2007, the registry contained over 40,000 trials, with more than 200 new trial registrations occurring weekly. Now four other clinical trials registries meet the ICMJE criteria, and many more journals have adopted the ICMJE clinical trials registration policy.
Also in 2004, the Pharmaceutical Research and Manufacturers Association announced that it was launching an online registry of clinical trial results. The association’s members, which include the world’s leading drug companies, will provide the results of all clinical trials completed after October 1, 2002, at clinicalstudyresults.org.
And since May 2006, researchers no longer can complain that journal editors will not publish negative or inconclusive results. PLoS’s journal PLoS Clinical Trials explicitly addresses the problem of publication bias: It will publish the results of randomized trials from all medical and public health disciplines. Publication does not depend on the trial’s outcome, size, or implied importance. Even negative results provide useful information about the effectiveness of treatments, alerting other researchers not to waste their time and resources on therapeutic dead ends. Indeed, researchers arguably have a moral obligation to publish their results, whether positive or negative, since subjects undertake risks to generate the data.
Collaboration between academia and industry should be encouraged, not attacked. In most areas of research, including computer science, geology, and chemistry, such ties are correctly seen as a source of innovation that has dramatically improved the quality of our lives during the last half-century.
Given the potential life-or-death consequences for patients, collaboration between the pharmaceutical industry and medical researchers needs to be monitored, and adjustments should be made whenever abuses come to light. But through such private efforts as financial disclosure requirements, registration of clinical trials, and peer-reviewed publication of all clinical trial results, the scientific research enterprise has shown itself capable of protecting the validity of research results without new government regulations.
“In a transparent atmosphere, misconduct can be detected, challenged, and if necessary, purged and punished,” Stossel noted in his 2005 New England Journal of Medicine article. “The intense energy currently dedicated to demonizing academic-industrial research relationships should be redirected toward developing better ways to identify and facilitate the type of partnerships that have brought more good, by far, than harm.” He added, “The public wants trustworthy science, and it can get that without new ethical rules. Even more it wants results—real lives saved—and it can’t get those if commercial sponsorship of research is made difficult, or impossible.”
Science Correspondent Ronald Bailey (firstname.lastname@example.org) is
the author of Liberation Biology: The Scientific and Moral Case for
the Biotech Revolution (Prometheus Books). This article derives in
part from research commissioned for a white paper on scientific
conflicts of interest by the non-profit consumer education
consortium the American Council on Science and Health. ACSH
receives no-strings-attached funding from individuals, foundations,
associations, and corporations. Bailey would also like to note that
he owns various fairly speculative biomedical stocks that he really
hopes will benefit a lot from industry-academic collaborations. The
number of shares he holds in any one company amounts to a few
hundred at most.