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Clinical Trials: A Methodologic
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^ Brennan 2013. Diffusion of Innovations. Why should surgeons care about clinical research methodology? J Am Coll Surg. A clinical trial protocol is a document used to define and manage the trial. Retrieved 16 October 2014. (These adverse event reports contain the opinion of both the investigator at the site where the adverse event occurred, and the sponsor, regarding the relationship of the adverse event to the study treatments). 2006;117:e680e687. Martin's Press.
Retrieved 2014-01-04. Using internet resources can, in some cases, reduce the economic burden.[61] New technologies enable sponsors and CRO's to reduce trial costs by executing online feasibility assessments and better collaborate with research centers such as ViS Research Institute. Clinical trials are traditionally expensive and difficult to undertake. BMC Med Res Methodol. All volunteers being considered for a trial are required to undertake a medical screening. Because of the lower randomization rates, these trials can be more expensive, require more total patients, and be more difficult to interpret than conventional trials.57The National Institute of Child Health and Human Development Neonatal Research Network is currently planning a comprehensive cohort trial comparing laparotomy and peritoneal drainage for extremely low birth weight infants with severe necrotizing enterocolitis or isolated intestinal perforation (personal communication, Blakely). Schulz KF, Chalmers I, Hayes RJ, Altman DG. Eligibility criteria of randomized controlled trials published in high-impact general medical journals: a systematic sampling review.
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