Patient population:

Does your Trial target the appropriate population, including age, gender, ethnicity, race, and any other relevant demographic factors?

Inclusion and exclusion criteria:

Does your Trial clearly define the inclusion and exclusion criteria for the study, and ensure that they are not unnecessarily restrictive, considering factors such as comorbidities, medications, and lifestyle factors that may disproportionately affect certain patient groups?

Recruitment plan:

Does your Trial have a description of the recruitment plan, including strategies to ensure adequate representation of diverse patient groups, such as community outreach, partnerships with patient advocacy groups, or targeted advertising?

Study design:

Have you evaluated the study design and ensured that it is appropriate for the target patient population, considering factors such as sample size, study endpoints, and outcome measures, and ensure that they are relevant to the patient population being studied?

Clinical Trial Diversity Checklist

Patient engagement:

Consider ways to engage and involve patients in the study design and implementation, such as through patient advisory boards or focus groups. This can help ensure that the study is relevant and meaningful to the patient population being studied.

Ethics and informed consent:

Consider ethical issues related to diversity in clinical trials, such as the potential for exploitation or tokenism. Ensure that informed consent materials are culturally appropriate and available in multiple languages, and that patients have a clear understanding of the risks and benefits of participation.  

Data collection and analysis:

Ensure that data collection and analysis methods are sensitive to differences in patient populations, and that data are disaggregated by relevant demographic factors. Consider using validated tools to assess patient-reported outcomes and ensure that they are culturally appropriate.

Monitoring and reporting:

Monitor the recruitment and retention of diverse patient groups throughout the study, and report on the diversity of the study population in study publications and regulatory submissions.

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