title: Are you "tilting at windmills" or undertaking a valid clinical trial?
abstract: In this review, several aspects surrounding the choice of a therapeutic intervention and the conduct of clinical trials are discussed. Some of the background for why human studies have evolved to their current state is also included. Specifically, the following questions have been addressed: 1) What criteria should be used to determine whether a scientific discovery or invention is worthy of translation to human application? 2) What recent scientific advance warrants a deeper understanding of clinical trials by everyone? 3) What are the different types and phases of a clinical trial? 4) What characteristics of a human disorder should be noted, tracked, or stratified for a clinical trial and what inclusion /exclusion criteria are important to enrolling appropriate trial subjects? 5) What are the different study designs that can be used in a clinical trial program? 6) What confounding factors can alter the accurate interpretation of clinical trial outcomes? 7) What are the success rates of clinical trials and what can we learn from previous clinical trials? 8) What are the essential principles for the conduct of valid clinical trials?
authors.affiliation: ICORD, University of British Columbia, Vancouver, Canada. steeves@icord.org
authors.forename: John D
authors.initials: JD
authors.lastname: Steeves
authors.forename: Jose
authors.initials: J
authors.lastname: Zariffa
authors.forename: John L K
authors.initials: JL
authors.lastname: Kramer
mesh_terms: D000818:Animals; D002985:Clinical Protocols; D002986:Clinical Trials as Topic / Q000941:ethics / Q000379:methods*; D004195:Disease Models, Animal; D005260:Female; D006801:Humans; D008297:Male; D017063:Outcome Assessment, Health Care; D011247:Pregnancy; D057170:Translational Research, Biomedical