Improving Generalizability of Clinical Trials by Including Underrepresented Populations

Results of health studies are the foundation for the practice of evidence based medicine and public health. Although randomized controlled trials remain the gold standard, the appropriate use of quasi-experimental and observational studies can provide quality results. Dissemination of clinical trial results in a systematic fashion not only facilitates the comparison of trials, but also allows for evaluation of quality. Quality clinical trials require careful attention to minimize bias and maximize internal and external validity. External validity of clinical trials is directly influenced by the generalizability of the trial results. In order for results to be generalizable, study populations must be representative of the population of interest; especially the population segment that will benefit most from the treatment being studied. Historically, clinical trial populations are dominated by white males. Underrepresented populations often face barriers to participation. Focused efforts to minimize barriers, such as lack of access, poor cultural competence, and financial strain, will increase participation. Funding sources and regulatory bodies also influence clinical trial quality by enacting policies that promote generalizability. Guidelines presented here will facilitate the breakdown of barriers to clinical trial participation leading to diverse participation and greater generalizability so that all individuals will benefit from novel interventions. Application of good leadership practice is needed to facilitate the breakdown of barriers and promote accrual of underrepresented populations. Ultimately, improving generalizability of clinical trial results will provide better information to use as the basis of health policy and practice.Master of Public Healt