Prospective trial registration for clinical research: what is it, what is it good for, and why do I care? 2011

Michael J Fredrickson, and Brian M Ilfeld
Department of Anaesthesiology, Faculty of Medical and Health Sciences, University of Auckland, Grafton, Auckland, New Zealand. michaelfredrickson@yahoo.com

Optimizing evidence-based medicine--and therefore the care of our patients--requires a public record of both the benefits and the risks of various medical interventions. Unfortunately, available evidence is often skewed because some clinical trials are withheld from publication; only selected data are reported, and statistical techniques are often inappropriately determined following data analysis. Prospective clinical trial registration (PCTR) is the public documentation of trial protocols--today primarily on the Internet--before data analysis (and ideally before trial commencement). The primary goals of PCTR are to reduce selective reporting and improve data analysis transparency, but it may also promote trial awareness for the public and other investigators. Prospective clinical trial registration is certainly not without problems, but many have been resolved, and the remainder is relatively minor in nature and easily overcome. Multiple organizations endorse (in some cases mandate) PCTR, including prominent committees of medical editors, the World Health Organization, the World Medical Association (responsible for the Helsinki Declaration), and, more recently, the US Food and Drug Administration. Although Regional Anesthesia and Pain Medicine does not currently require registration for published articles, PCTR in this and other anesthesiology and pain journals may become mandatory within the next few years. Potential authors/investigators will therefore benefit from becoming familiar with PCTR before mandatory registration implementation, and familiarity among readers may improve interpretation and understanding of clinical research results.

UI MeSH Term Description Entries
D011446 Prospective Studies Observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group. Prospective Study,Studies, Prospective,Study, Prospective
D012042 Registries The systems and processes involved in the establishment, support, management, and operation of registers, e.g., disease registers. Parish Registers,Population Register,Parish Register,Population Registers,Register, Parish,Register, Population,Registers, Parish,Registers, Population,Registry
D002986 Clinical Trials as Topic Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries. Clinical Trial as Topic
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D035843 Biomedical Research Research that involves the application of the natural sciences, especially biology and physiology, to medicine. Medical Research,Experimental Medicine,Investigational Medicine,Investigative Medicine,Research, Biomedical,Research, Medical,Medicine, Experimental,Medicine, Investigational,Medicine, Investigative

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