Epidemiology

Understand the patient population/epidemiology of the disease you are studying, set goals for the trial that capture the disease epidemiology and track your results.

Clinical Trial Sites

Based on the epidemiology of the disease and demographics of the site catchment area, select clinical trial sites (and the site leads) with the goal of achieving a representative patient population.

Review Resources

Review existing resources aimed at improving enrollment of underrepresented participants in clinical trials (e.g., FDA diversity plan, ICH guidelines, MRCT diversity clinical research toolkit, Just Ask, NIH All of Us Research Program, etc.).

Patient Advocacy Groups

Engage with relevant patient advocacy groups and lived experience experts (LEEs)* early and often as:

  • You craft your research question.
  • Outline your enrollment goals by population demographics; and
  • Strive to build trust with the patient community that will be participating in the study.
HCPs

Seek meaningful contribution from health care providers (HCPs) on study concept/design.

* Lived Experience Experts (LEEs) are individuals, their caregivers, and family members directly impacted by hematologic diseases. Their personal knowledge of the disease gives them the unique ability to translate lived experiences into meaningful system change. Collaborating with patient advocacy groups may be a good source for identifying appropriate LEEs.