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Journal will require clinical trials to summarize earlier results.

Starting in August 2005, The Lancet "will require authors of clinical trials submitted to The Lancet to include a clear summary of previous research findings, and to explain how their trial's findings affect this summary."

In a statement published July 9, The Lancet explained that much of the reason for this requirement is to prevent research on patients that is unethical because it does not need to be done at all, as the superiority of one treatment tested over another was already known from previous work. "Unnecessary and badly presented clinical research injures volunteers and patients as surely as any other form of bad medicine, as well as wasting resources and abusing the trust placed in investigators by their trial participants." The statement also notes the problem of unpublished research, which is being addressed by requiring companies to register human trials (so that future researchers will not expose volunteers to unnecessary risks because they did not know that the previous studies had been done).

Comment: It is astonishing that such a rule would need to be required. Why wouldn't any report of a clinical trial summarize previous work? One practical problem may be that it takes so long for trials to be funded and organized, with all the negotiations, permissions, and hiring of staff, plus the time for recruiting volunteers, then for the trial to actually run, and then the time to prepare the data and write and publish the results, that by the end of all this it may be clear that the trial was no longer necessary--a consequence the researchers may not want to advertise. Perhaps operations research (now widely recommended for healthcare delivery in areas where there has been no modern infrastructure in the past) could be applied to clinical trials in rich countries as well, to prevent unnecessary delays and make the research more current and relevant.

Comment on "data exclusivity": While not mentioned in The Lancet statement, medical ethics should also look at international trade agreements that require unnecessary trials. Under data exclusivity, a controversial rule first imposed in 1987, for a period of about eight years after approval of a new drug, a country cannot accept an application for a generic bioequivalent to a brand-name drug even if the patent is expired or is otherwise not a problem, because that is called "unfair" use of the knowledge that the brand-name drug worked in the first place. Instead, a new clinical trial would have to start over and test the generic to treat the disease in patients in order to be approved for that use, as if the first trial had not been done--an unnecessary trial because it would require patients to take risks to reprove what had already been well established. In addition, the re-run trial would likely expose patients to treatment known to be inferior. It is astonishing that the U.S. and other rich countries routinely impose trade rules that would require unethical trials, to invent yet another excuse to block inexpensive medicines from being approved and used.

Reference: Young C and Horton R. Putting clinical trials into context. The Lancet. July 9. 2005; volume 366, pages 107-108.
COPYRIGHT 2005 John S. James
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Author:James, John S.
Publication:AIDS Treatment News
Date:Jun 24, 2005
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