Durham, North Carolina – Parexel Academy, a leading provider of educational programs for clinical research professionals, is pleased to announce the launch of its highly anticipated course on Representation in Clinical Trials. This program comes in response to the recent legislation passed in December 2022, requiring the Food and Drug Administration (FDA) to prioritize diversity in clinical trials.
Under the Consolidated Appropriations Act, the FDA now mandates that sponsors submit diversity action plans alongside phase 3 trials submitted to the agency. These action plans should outline the sponsor’s enrollment goals, supporting rationale, and strategies for achieving those objectives. The FDA has also been directed to issue final guidance on trial diversity, ensuring the inclusion of racial and ethnic minorities in the study population, relative to disease prevalence in these subgroups.
Recognizing the importance of this legislative requirement and the need for comprehensive training, Parexel Academy has developed a specialized course tailored to investigators and site staff. This cutting-edge training program will equip clinical research professionals with the knowledge and skills necessary to navigate the complexities of recruiting and retaining a representative population in all phases of clinical research.
“We are thrilled to provide investigators and site staff with this vital training,” said Jamie Langley, Global Head of Parexel Academy. “By offering a comprehensive understanding of representation in clinical trials, we aim to empower professionals to meet the evolving requirements set forth by the FDA and contribute to the advancement of inclusive healthcare.”
Through this course, participants will learn the foundations of representative participation and current legislative requirements. The program addresses various clinical characteristics, including comorbidities, while ensuring compliance with relevant regulatory requirements.
“As clinical research evolves, we must foster an inclusive environment that reflects the population we serve,” said Langley. “We are proud to be able to deliver this training, showing investigators and site staff practical approaches they can take to be more inclusive.”
Parexel Academy encourages all investigators and site staff to actively seek out related training programs, preparing themselves to meet the legislation requirements and contribute to advancing patient-centric clinical trials. By embracing representation, clinical research professionals can help ensure that clinical trials are truly representative and accessible to all.
To learn more about the Representation in Clinical Trials course offered by Parexel Academy, please contact ParexelAcademy@parexel.com.
About Parexel Academy
Parexel Academy is a leading provider of educational programs for clinical research professionals. By equipping individuals with the latest advancements and best practices, Parexel Academy empowers clinical research professionals to drive forward the development of life-changing therapies and improve patient outcomes. Committed to building and enhancing capabilities within the clinical research workforce so that, together, we positively impact the lives of patients around the world. We do training – With Heart™.
