The job of registering all trials and checking up on unreported results will pose a considerable challenge to agency officials. An analysis published in May (J. Am. Med. Assoc. 307, 1838–1847, 2012) of the characteristics of clinical trials registered in ClinicalTrials.gov “raises questions about the best methods for generating evidence, as well as the capacity of the clinical trials enterprise to supply sufficient amounts of high-quality evidence needed to ensure confidence in guideline recommendations.” The analysis was conducted by the Clinical Trials Transformation Initiative (CTTI), a public-private partnership founded by the FDA and the Duke Translational Medicine Initiative. First author Rob Califf, of the Duke Translational Medicine Institute of Durham, North Carolina, says new features introduced with recent FDA reauthorizations are oriented toward providing more transparency in the clinical trials enterprise, “But more can be done,” he says.
Past efforts to move industry into greater compliance with the aims of ClinicalTrials.gov have fallen short. In 2004, the New York State Attorney General sued London-based GlaxoSmithKline (GSK) for failing to reveal unfavorable results from trials of its antidepressant Paxil (paroxetine) in children (the case was settled). That same year, the International Committee of Medical Journal Editors said its members' journals would not publish reports of trials unless they had been registered in ClinicalTrials.gov—a policy that apparently has been only poorly implemented.
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