title: Assessing the population representativeness of colorectal cancer treatment clinical trials.
abstract: The generalizability (external validity) of clinical trials has long been a concern for both clinical research community as well as the general public. Results of trials that do not represent the target population may not be applicable to the broader patient population. In this study, we used a previously published metric Generalizability Index for Study Traits (GIST) to assess the population representativeness of colorectal cancer (CRC) treatment trials. Our analysis showed that the quantitative eligibility criteria of CRC trials are in general not restrictive. However, the qualitative eligibility criteria in these trials are with moderate or strict restrictions, which may impact their population representativeness of the real-world patient population.
authors.lastname: Zhe He
authors.lastname: Zhiwei Chen
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: George
authors.forename: Gloria
authors.initials: G
authors.lastname: Lipori
authors.lastname: Bian
mesh_terms: D000367:Age Factors; D000368:Aged; D002986:Clinical Trials as Topic; D015331:Cohort Studies; D015179:Colorectal Neoplasms / Q000628:therapy*; D003404:Creatinine / Q000378:metabolism; D003710:Demography; D005260:Female; D006801:Humans; D008297:Male
chemical_list: D003404:Creatinine