2016 38th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC) 2016
DOI: 10.1109/embc.2016.7591353
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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 c… Show more

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Cited by 3 publications
(2 citation statements)
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“…Rubin et al [ 14 ] categorized the eligibility criteria of three cancers into 24 categories and developed the tool for authoring new clinical trial protocols based on similarity among eligibility criteria. He et al [ 15 ] collected eligibility criteria from colorectal cancer treatment clinical trials and assessed the population representativeness in quantitative and qualitative aspects respectively. Van Spall et al [ 16 ] selected eligibility criteria from the randomized controlled trials published in high impact journal, and characterized the nature, extend and contribution of 38 categories of exclusion criteria.…”
Section: Introductionmentioning
confidence: 99%
“…Rubin et al [ 14 ] categorized the eligibility criteria of three cancers into 24 categories and developed the tool for authoring new clinical trial protocols based on similarity among eligibility criteria. He et al [ 15 ] collected eligibility criteria from colorectal cancer treatment clinical trials and assessed the population representativeness in quantitative and qualitative aspects respectively. Van Spall et al [ 16 ] selected eligibility criteria from the randomized controlled trials published in high impact journal, and characterized the nature, extend and contribution of 38 categories of exclusion criteria.…”
Section: Introductionmentioning
confidence: 99%
“…Only 794 (4.4%) of all the 17,858 interventional clinical studies in ClinicalTrials.gov on lung neoplasms between 2000 and 2014 explicitly excluded patients >= 65 years old. Our recent study also shows that the quantitative eligibility criteria in cancer studies did not pose notable restrictions in the target population [10]. However, the qualitative eligibility criteria with moderate or strict restrictions were frequently observed in these trials.…”
Section: Introductionmentioning
confidence: 91%