Is Our Science Representative? A Systematic Review of Racial and Ethnic Diversity in Orthopaedic Clinical Trials from 2000 to 2020.
Thomas B CwalinaTarun K JellaGrigory A ManyakAndy KuoAtul F KamathPublished in: Clinical orthopaedics and related research (2021)
Investigators should initiate discussions about race and ethnicity reporting in the early stages of clinical trial development by surveying available published evidence for relevant health disparities, social determinants, and, when warranted, genomic risk factors. The decision to include or exclude race and ethnicity data in study protocols should be based on specific hypotheses, necessary statistical power, and an appreciation for unmeasured confounding. Future studies should evaluate cost-efficient mechanisms for obtaining baseline social covariate data and investigate researcher perspectives on current administrative workflows and decision-making algorithms for race and ethnicity reporting.
Keyphrases
- clinical trial
- decision making
- healthcare
- mental health
- risk factors
- public health
- electronic health record
- adverse drug
- machine learning
- big data
- phase ii
- open label
- study protocol
- randomized controlled trial
- emergency department
- health information
- dna methylation
- gene expression
- african american
- climate change
- genome wide