Participant Diversity and Inclusive Trial Design: A Meta-Epidemiologic Study of Canadian Randomized Clinical Trials
Abstract
OBJECTIVE
To describe the demographic and social identities of participants in contemporary Canadian randomized clinical trials (RCTs).
STUDY DESIGN AND SETTING
A meta-epidemiologic study included published reports of phase 2 and 3 RCTs that exclusively recruited adults living in Canada and were registered on ClinicalTrials.gov between January 1, 2010, and December 31, 2019. Study design and participant demographics were abstracted from eligible articles in duplicate using frameworks for understanding participant diversity such as PROGRESS-PLUS.
RESULTS
We identified 118 RCTs with 17,387 participants. Most reported participant sex (n=105, 89.0%), few reported gender (n=12, 10.2%), and none reported both. Among articles reporting sex, there were 11,066 female (63.6%), 5,402 male (32.8%), and one intersex (<0.1%) participants. There were 477 women (54.1%) and 404 men (45.9%) participants. No studies reported gender diverse participants. When excluding studies that only recruited one sex and/or gender, 51.8% of participants were male (n=4,774/9,219) and 47.5% were men (n=446/850). Race and/or ethnicity was reported for 4,124 participants (23.7%) in 31/118 (26.3%) of RCTs; of these, 72.0% were white (n=2,969), 2.7% were Black (n=113), and 0.2% were Indigenous (n=7). Eligibility criteria related to specific PROGRESS-PLUS factors was rare except for cognition (n=42, 35.6%), substance use (n=25, 21.7%), pregnancy (n=29, 24.5%), breastfeeding (n=16, 13.6%), and older age (n=26,…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 17,387 participants or records.
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