The American College of Clinical Pharmacology® (ACCP) published a Position Paper entitled “The Importance of Diversity and Inclusion in Drug Development and Clinical Trial Conduct” addressing the topic of diversity in clinical trials and drug development.
| ASHBURN, Va., Jan. 18, 2023 /PRNewswire/ -- The American College of Clinical Pharmacology® (ACCP) published a Position Paper entitled “The Importance of Diversity and Inclusion in Drug Development and Clinical Trial Conduct” addressing the topic of diversity in clinical trials and drug development. This position highlights the need for greater diversity in participants in the drug development process. ACCP strongly recommends that researchers and health care professionals across the care continuum be more active regarding the need for greater diversity of trial participants. While federal agencies, advocacy groups and the pharmaceutical drug/medical device sectors are aligned on the importance of diversity in clinical research, the actions taken to date have produced, at best, a partial response from our communities within the United States. A recent FDA Diversity guidance, which ACCP fully supports, recommends that sponsors submit a diversity plan as part of the Investigational New Drug application as soon as practical during drug development and before conducting the pivotal trials. This new guidance is certainly timely considering the global attention placed on vaccine development to prevent COVID infections and recent findings that showed members of racial/ethnic minority groups and older adults living in structural and socially unequal communities were underrepresented in the clinical trials for approved vaccines.
The ACCP strongly recommends that researchers and health care professionals across the care continuum be more active regarding the need for a greater diversity of participants in drug development and clinical trials. This can be supported through active participation in their professional and academic institutions, societies and local communities. Health care professionals should strongly consider actions of advocacy, mentoring, education and volunteering to better inform all stakeholders regarding the need for a greater diversity of participants in clinical trials and the drug development process. As health care professionals, regulators and researchers, we should strive to ensure our actions in the design, conduct, reporting and communication of clinical research reflect the diverse needs of our communities. About ACCP ACCP is a non-profit association providing accredited Continuing Education, publications and career-enhancing opportunities to clinical pharmacology healthcare professionals.
SOURCE American College of Clinical Pharmacology |
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