Testing cardiovascular drug safety and efficacy in randomized trials.

ABSTRACT: Randomized trials provide the gold standard evidence on which rests the decision to approve novel therapeutics for clinical use. They are large and expensive and provide average but unbiased estimates of efficacy and risk. Concern has been expressed about how unrepresentative populations and conditions that pertain in randomized trials might be of the real world, including concerns about the homogeneity of the biomedical and adherence characteristics of volunteers entered into such trials, the dose and constancy of drug administration and the mixture of additional medications that are restricted in such trials but might influence outcome in practice. A distinction has been drawn between trials that establish efficacy and those that demonstrate effectiveness, drugs that patients actually co

SUBMITTER: FitzGerald GA 

PROVIDER: S-EPMC4011393 | biostudies-literature | 2014 Mar

REPOSITORIES: biostudies-literature