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An Introduction to Patient Diversity in Clinical Trials – Part 1
March 8 @ 10:00 - 11:00 UTC+0
Diversity in Clinical Trials - Part 1: An Introduction to Patient Diversity in Clinical Trials
Wednesday, March 8, 2017 @
- 10:00 am EST (NYC, USA)
- 3:00 pm GMT (London, UK)
- 4:00 pm CET (Paris, FR)
Vice President, Patient Insights & Engagement, Mapi Group
Because diseases impact populations differently, we need to help ensure that medical products are safe for everyone. To do this, we need a diverse pool of research participants—racial and ethnic minorities, women, and the elderly.
Clinical trial participants need to more closely mirror the patients who will ultimately use the medicine. This is especially important when considering health disparities — diseases that occur more frequently or appear differently in unique populations. Historically, the elderly, women (in some therapeutic areas), and racial/ethnic minorities have been underrepresented in trials. In response to under-representation in recent years, Congress included Section 907 in the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, giving FDA direction to evaluate this issue and take action. FDA has responded in multiple ways, including the creation of Drug Trials Snapshots that give the public readouts of the demographic profile of people participating in clinical trials for approved drugs.
To overcome the barrier of recruitment, retention and engagement of a diverse clinical research, population, deeper patient and healthcare practitioner insights are critical. This is the first in a series of webinars to outline best practices in developing patient Insight programs focused on assuring patient diversity.
In this 1 hour session we will provide an overview of the fundamental barriers to diversity such as:
- Access to Clinical Trials for the under-served population
- Underlying perceptions of physicians, investigators and patients that permeate clinical trials
- Operational approaches of CROs and the pharmaceutical industry
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