Comparison of acceptance of clinical versus basic studies on drugs and therapeutics in infants and children. 1993

G Koren, and N Klein
Department of Pediatrics, Hospital for Sick Children, Toronto, Ont., Canada.

Many clinicians and clinician-scientists have serious concerns that clinical studies (i.e. studies with patients) are less favorably accepted than basic ('bench') projects by funding agencies and by promotion committees of university departments. However, this commonly held view has not been previously verified. To test whether bias exists against clinical studies, we compared the acceptance rate of clinical vs. basic studies dealing with drugs and therapeutics in children, which were submitted to a large scientific meeting. Of 197 abstracts reporting on drug/therapeutic studies, submitted to the Society for Pediatric Research in 1993, there were 133 clinical and 64 basic studies. Fifty-nine (44.3%) of the clinical studies were accepted, significantly less than the basic projects (n = 47 or 73.4%, p < 0.0001). A basic paper was 66% more likely to be accepted (95% CI 50.7-82.6%). This trend was consistent for different groups of drugs/therapeutics, including analgesics, surfactants, corticosteroids, vaccines, hormones, and antiasthmatics. To examine whether the lower rate of acceptance of clinical papers is the result of lower scientific standard, all papers were scored for their quality by raters who were blinded to their acceptance or rejection status. In general, rejected clinical papers scored significantly higher than rejected basic papers (16 +/- 1.8 vs. 14.8 +/- 1.0, p < 0.05). Our study supports the commonly held but previously unproven view that there is a bias against clinical research, in the context of patient-based studies, when compared to basic (bench) research.

UI MeSH Term Description Entries
D010372 Pediatrics A medical specialty concerned with maintaining health and providing medical care to children from birth to adolescence.
D010600 Pharmacology The study of the origin, nature, properties, and actions of drugs and their effects on living organisms. Pharmacologies
D010601 Pharmacology, Clinical The branch of pharmacology that deals directly with the effectiveness and safety of drugs in humans. Clinical Pharmacology
D011643 Publishing "The business or profession of the commercial production and issuance of literature" (Webster's 3d). It includes the publisher, publication processes, editing and editors. Production may be by conventional printing methods or by electronic publishing. Electronic Publishing,Publishing, Electronic,Electronic Publishings,Publishings, Electronic
D012106 Research Critical and exhaustive investigation or experimentation, having for its aim the discovery of new facts and their correct interpretation, the revision of accepted conclusions, theories, or laws in the light of newly discovered facts, or the practical application of such new or revised conclusions, theories, or laws. (Webster, 3d ed) Research Priorities,Laboratory Research,Research Activities,Research and Development,Activities, Research,Activity, Research,Development and Research,Priorities, Research,Priority, Research,Research Activity,Research Priority,Research, Laboratory
D003226 Congresses as Topic Works about conferences, conventions or formal meetings usually attended by delegates representing a special field of interest. Conferences,Conference Proceedings as Topic,Conferences and Congresses,Conferences and Proceedings,Congresses and Conferences,Professional Meetings and Conferences,Congresses as Topics,Proceedings and Conferences,Topics, Congresses as

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