Addressing Diversity in Patient Recruitment for Clinical Research

The demographics of clinical trials today still do not reflect the racial, ethnic, or gender diversity of target patient populations around the world. This poses a significant problem for the industry. Missing race and ethnicity data in medical assessments can lead to biased estimates of treatment effects due to a lack of exchangeability. Ensuring people from diverse backgrounds join clinical trials is key to advancing health equity. Does real-world data serve as the key to increasing diverse representation in clinical research? Why does technology play a pivotal role in this transformation?

Register Free: https://www.pharmexec.com/pe_w/patient-diversity-recruitment

Event Overview:

It has been 25 years since Congress passed the National Institutes of Health Revitalization Act requiring federally funded clinical research programs to prioritize inclusion of women and minorities. Both the NIH and the Food and Drug Administration have mounted numerous initiatives, including regulatory guidance aimed to enable and fulfill the law’s intent.

Despite parallel efforts by biopharmaceutical innovators, the demographics of clinical trials today still do not reflect the racial, ethnic or gender diversity of target patient populations around the world. This is true for trial subjects, of whom an estimated 83 percent are white, but also the representation of investigators at many trial sites as well.

This is critical because clinical care and medical product development are not yet currently representative of all patients. This poses a significant problem for the industry. Missing race and ethnicity data in medical assessments can lead to biased estimates of treatment effects due to a lack of exchangeability. People from diverse groups are underrepresented in clinical research. This is a concern because different people may react differently to certain medical products. Ensuring people from diverse backgrounds join clinical trials is key to advancing health equity.

Does real-world data serve as the key to increasing diverse representation in clinical research? Why does technology play a pivotal role in this transformation?

Key Learning Objectives:

• Learn the importance of diversity and how people from diverse groups are underrepresented in clinical research.
• Hear about how organizations are ensuring representativeness in patient recruitment for clinical trials to better health equity.
• Understand how diverse and inclusive patient recruitment could serve as key access enablers for patients to receive clinical research as a care option
• Learn about the guardrails and key considerations that clinical sites, CROs, and research facilities should keep front of mind when designing clinical trials and recruiting patient cohorts

Who Should Attend:

• Clinical researchers, data scientists, and clinical decision teams responsible for:
  • Clinical development planning and study design
  • Management of patients and measurement of clinical outcomes
  • Clinical data management, collecting and evaluating trial metrics
  • Project management of studies, process optimization, and operational excellence

Speakers

CARLA RODRIGUEZ-WATSON PhD, MPH
Director of Research
Reagan-Udall Foundation for the Food and Drug Administration (FDA)

Carla Rodriguez-Watson, PhD, MPH is the Director of Research for the Reagan-Udall Foundation for the FDA, Carla is focused on continuously developing and enhancing a portfolio of work that leverages real-world data and experiences to inform and conduct clinical and post-market drug safety and effectiveness studies. Projects include those focused on developing and advancing frameworks and tools to systematically describe data sources and methods for use in pre and post-market studies of product safety and effectiveness; as well as the Innovation in Medical Evidence, Development and Surveillance (IMEDS) Program – where such tools can be leveraged. IMEDS leverages a distributed network and tools developed by the FDA’s Sentinel initiative to design and execute post-market drug safety studies in a network of 9 healthcare systems representing over 111 M persons. Carla brings her extensive background in public health surveillance and health outcomes research to this work.

She earned her PhD in Epidemiology from the University of Washington School of Public Health (dissertation: Accuracy of emergency department chief-complaint to identify pediatric influenza from Emergency Department Visits), her MPH from Columbia University Mailman School of Public Health, and her BA from Rutgers University.

ANGEL AKINBINU
Senior Director, Clinical Trial Diversity
Syneos Health

Angel Akinbinu is Senior Director of Clinical Trial Diversity at Syneos Health, where she leads the strategy development and implementation of diversity, equity, and inclusion in clinical trials. Angel has more than 10 years of clinical research experience helping customers advance equitable solutions.

Prior to joining Syneos, she worked in both CROs and large pharma, creating and executing patient recruitment and retention strategies, later transitioning to work focused on increasing representation and access for underserved and underrepresented patient populations in clinical trials. She has worked in multiple therapeutic areas including oncology, infectious disease and vaccines, neuroscience, and immunology.

Angel earned her Bachelor of Arts degree from Hampton University and Master of Arts in Criminology & Criminal Justice from the University of Maryland. She lives in the Raleigh, NC area with her husband and two children.


KATHERINE VANDEBELT
Global Vice President Clinical Innovation
Oracle

Katherine (Kathy) Vandebelt believes patients are the most important constituent in clinical development and provide the necessary information to assess the safety and efficacy of new medicines. Kathy is using the power of technology to introduce new experiences and expectations to make the clinical research ecosystem better for patients, healthcare providers, sponsors and regulators. With over thirty years of experience in clinical research working in different geographies and across various therapeutic areas, Kathy has worked with various organizations to advance their clinical operations and business processes to a better operating model.

Register Free: https://www.pharmexec.com/pe_w/patient-diversity-recruitment