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DIA 2021 Global Annual Meeting


Implicit Bias in Early Phase Clinical Trials: The Sociocultural Implications of Advancing the Science

Session Chair(s)

Lovingly  Park, PhD

Lovingly Park, PhD

  • Director, Clinical Research
  • Supernus Pharmaceurticaals, Inc., United States
Implicit bias against diversity and inclusion (D&I) are inherent in early phase clinical trial designs. Although addressing representation is important from a sociocultural perspective, it is also tantamount to ensuring representation in studies involving sophisticated biomarker approaches and precision medicine. Unfortunately, research protocols do not lend themselves to D&I due to requirements tied to proficiency with the English language, minimum required years of education, binary gender/sex requirements, and the need for a ‘informant’ or ‘study partner’. Behavioral and cognitive outcomes that are often used in clinical research also have limited applicability in non-English speaking populations. As a result of these various factors, representation in trial populations become imbalanced and absent, limiting our ability to make inferences about safety and tolerability to homogenous populations. This panel will address aspects of trial design that is most heavily influenced by the lack of diversity and inclusion such as enrollment criteria, biomarker and clinical outcomes, as well as models to consider when creating patient centric environments in research settings. We will identify the scientific, regulatory, and social challenges facing the industry while providing tangible solutions that will align with D&I initiatives as we advance the science through clinical development. Join the DIA Patient Engagement Community for a follow up round table discussion (session #229 RT L) on Tuesday, June 29, 1:00PM - 2:00PM EDT.
Learning Objective : Discuss participation in early phase clinical trials among underrepresented groups; Identify common barriers and solutions to D&I in early phase clinical research; Describe the current trends in addressing D&I in the industry and provide a framework for advancing the field from both the investigator, sponsor, and participant perspectives.

Speaker(s)

Lucas  Kempf, MD

FDA Guidance on Diversity

Lucas Kempf, MD

  • Vice President, RCS
  • Parexel, United States
Lovingly  Park, PhD

Ensuring Representation in Early Phase Clinical Trials: The Importance of Diversity and Inclusion

Lovingly Park, PhD

  • Director, Clinical Research
  • Supernus Pharmaceurticaals, Inc., United States
Mandi L. Pratt-Chapman, PhD

Academic Update

Mandi L. Pratt-Chapman, PhD

  • Associate Center Director, Patient Centered Initiatives & Health Equity
  • The GW Cancer Center, United States