Retrospective and Prospective Identification of Unpublished Controlled Trials: Lessons From a Survey of Obstetricians and Pediatricians

Abstract

Investigations in which statistically significant differences between treatment groups have not been observed are less likely than others to be reported in scientific journals. In clinical research, this selective suppression of "negative" results may lead to the adoption of ineffective or hazardous treatments. In an attempt to obtain information about unpublished trials in perinatal medicine, letters were sent to 42,000 obstetricians and pediatricians in 18 countries. As a result, we were notified of 395 unpublished randomized trials. Only 18 of the trials had been completed more than 2 years before the survey, a period during which at least 2300 reports of perinatal trials had been published. Of the 395 unpublished trials, 125 had ceased recruitment within the 2 years prior to the survey, 193 were actively recruiting at the time of the survey, and 59 were about to begin recruitment. It was concluded that publication bias will not be addressed successfully by attempts to obtain information about unpublished trials retrospectively. However, since the response rate to our request for details about ongoing and planned trials was good, prospective registration of trials at inception appears to be a feasible approach to reducing publication bias and its adverse consequences. An additional merit of prospective registration of clinical trials is that it should reduce unnecessary duplication (as opposed to necessary replication) in research and promote more effective collaboration.

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