Few Studies Reporting Results at US Government Clinical Trials Site
Authors: B. M. Kuehn
Journal: JAMA (2012)

FEWER THAN ONE-QUARTER OF THE clinical trials registered at ClinicalTrials.gov (http://clinicaltrials .gov), a federal database set up to provide public information about clinical trials, have had their results posted in the database within a year of publication, 2 recent analyses have found. The findings may suggest the need to boost awareness among researchers about the requirement to report and the value of reporting results in the database, or may require enforcement efforts by regulators or others with authority over clinical trial investigators. Federal agencies and academic institutions pushed for the creation of the database to promote greater public access to clinical trial data and to prevent the scientific literature from being skewed by selective reporting of positive results. Officials at the National Library of Medicine, which administers the database, and the US Food and Drug Administration (FDA), which is charged with enforcing participation in the database by some trials, said they are working through nuances in the law to clarify which trials are subject to the rules and have launched some efforts to boost participation. “We wanted to highlight to the research community that reporting of some clinical trials information is mandatory,” said Andrew P. Prayle, MDChB, a doctoral research fellow at the United Kingdom’s National Institute for Health Research and an author of one of the analyses (Prayle AP et al. BMJ. 2011;344:d7373 [published online January 3, 2012]). BOOSTING REGISTRATIONS The National Library of Medicine launchedClinicalTrials.govin2000togive patients and other stakeholders easy accesstoinformationaboutclinicalresearch. AccordingtoMichaelR.Law,PhD,assistantprofessorintheCentreforHealthServices and Policy Research at the University of British Columbia in Vancouver, Canada, and colleagues, who published another recent analysis of the database (Law MR et al. Health Aff [Millwood]. 2011;30[12]:2338-2345), in September 2005, the International Committee of Medical Journal Editors (ICMJE) began requiring investigators to register new trials inClinicalTrials.govbefore initiatingpatientenrollment inorder tobeconsidered for publication in member journals. This mandate caused a huge spike intrial registrations,saidLawandhiscolleagues, with 3474 registrations that month compared with an average of 78 registrationspermonthpreviously.Over the following 2 years, registrations averaged about 372 a month. The director of ClinicalTrials.gov, Deborah Zarin, said the enforcement of this requirement sent “ripples” through theacademicresearchcommunityasword spread about high-profile articles being turned down by journals such as JAMA andtheNewEngland JournalofMedicine. “Each enforcement action gets magnified by the fear factor,” she said. In December 2007, another, smaller, spike in publications occurred when a provision of the Food and Drug Administration Amendments Act (FDAAA) went into effect. This provision required study sponsors or investigators to register any clinical trials that have a study site in the United States or arebeing conducted under an investigational new drug application from the FDA. This requirement also produced a sharp increase in registrations, according to Law and his colleagues, with 755 registra-