title: Randomized controlled trials 1: Design.
abstract: Today's clinical practice relies on the application of well-designed clinical research, the gold standard test of an intervention being the randomized controlled trial. Principles of the randomized control trial include emphasis on the principal research question, randomization, blinding; definitions of outcome measures, of inclusion and exclusion criteria, and of comorbid and confounding factors; enrolling an adequate sample size; planning data management and analysis; preventing challenges to trial integrity such as drop-out, drop-in, and bias. The application of pretrial planning is stressed to ensure the proper application of epidemiological principles resulting in clinical studies that are feasible and generalizable. In addition, funding strategies and trial team composition are discussed.
authors.affiliation: Medicine, Patient Research Centre, Health Science Centre, Memorial University of Newfoundland, 300 Prince Philip Drive, St. John's, NF, Canada, A1B 3V6, bcurtis@mun.ca.
authors.forename: Bryan M
authors.initials: BM
authors.lastname: Curtis
authors.forename: Brendan J
authors.initials: BJ
authors.lastname: Barrett
authors.forename: Patrick S
authors.initials: PS
authors.lastname: Parfrey
mesh_terms: D015982:Bias; D003625:Data Collection / Q000379:methods; D015340:Epidemiologic Research Design; D005500:Follow-Up Studies; D006801:Humans; D015337:Multicenter Studies as Topic / Q000379:methods; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D018401:Sample Size