Ensuring diversity in clinical trials: The role of clinical pharmacology

Increasing the diversity of participants in clinical trials is important as it allows further examination of drug effects in all subgroups of patients who will be prescribed an approved medicine. It also gives patients more confidence in the medicine when they know that individuals similar to themselves have participated in pivotal efficacy and safety trials. Pfizer recently committed to ensuring that its clinical trials reflect racial and ethnic demographics of the patient populations in the countries and communities in which the trials are conducted. This paper furthers Pfizer's commitment by declaring what Clinical Pharmacology (CP) can do to advance this goal and expand patient populations to include other groups such as pediatrics, elderly, and those with organ impairment. This includes steps such as: Creating a clinical trial diversity plan to help ensure trial participation across races and ethnicities Using emerging knowledge to lower barriers of entry into clinical trials by enabling participation of historically underrepresented groups Embracing patient-centric bioanalytical and digital health technologies to increase clinical trial accessibility Improving patient benefit through model-based strategies including use of real-world evidence and innovative study design approaches Ensuring thoughtful interpretation of clinical trial results that impact the medicines use Pfizer Clinical Pharmacology commits to these actions, which create a framework for the CP Community to enable increased diversity among participants in clinical trials and improved dosing recommendations for all patient subgroups.