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Published on: January 12, 2018
A framework for evaluating the diversity of clinical trials
Foluso Agboola1, Abigail C Wright1
1Institute for Clinical and Economic Review (ICER), Boston, MA, 02108, USA.
A new Clinical trial Diversity Rating (CDR) framework offers a standardized method to assess and enhance participant diversity in medical research. This tool aims to improve representation across various demographic groups in clinical trials.
Area of Science:
- Clinical trial methodology
- Health equity research
- Evidence-based medicine
Background:
- Improving diversity in clinical trials is crucial for evidence-based medicine.
- Current methods for evaluating clinical trial diversity lack uniformity.
- Standardized evaluation is needed to guide improvements in trial demographics.
Purpose of the Study:
- To introduce and describe the development of the Clinical trial Diversity Rating (CDR) framework.
- To outline considerations for evaluating demographic diversity in clinical trials.
- To demonstrate the application of the CDR framework with an example.
Main Methods:
- A four-step development process was employed.
- Included a scoping review of 110 publications on clinical trial diversity.
- Incorporated a cross-sectional study and advisory group feedback.
Main Results:
- Race/ethnicity, sex, and age are common diversity metrics.
- Most studies defined evaluation benchmarks, but few used disease prevalence (48%).
- The CDR framework integrates demographic characteristics, benchmarks, and thresholds for an overall rating.
Conclusions:
- The CDR framework offers an objective and transparent method for evaluating clinical trial diversity.
- Applicable to Health Technology Assessment bodies, regulators, policymakers, and researchers.
- Aims to facilitate examination, monitoring, and improvement of diversity in clinical trials.
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