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Clinical Trials in Special Patient Populations

An Outsourcing-Pharma editorial webinar



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Available On Demand

Duration:60 minutes

Abstract:

The term “special population” exists to protect certain vulnerable patient groups that require additional consideration as it pertains to clinical research, including women, pediatrics, and the elderly.

Regulatory agencies require clinical trial sponsors to present a summary of safety and effectiveness data by demographic subgroups, for age, gender, and ethnicity – because one size does not fit all.

In this webinar, we will explore these different patient populations, outline the challenges to trial recruitment and retention, and overview the regulatory efforts underway to ensure inclusive research.

Sponsors

Lonza Pharma Marken
QPS HoldingsSynteract

Speakers

Annemarie Forrest

Director of Projects
Clinical Trials Transformation Initiative (CTTI)

Annemarie Forrest, RN, MS, MPH, is the Director of Projects at the Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by Duke University and the U.S. Food and Drug Administration, where she provides senior operational leadership, overseeing CTTI’s project portfolio and project management team. She has held a variety of clinical research positions over a 20-year research career.

Christina Brennan, MD, MBA

Vice President of clinical research
The Feinstein Institutes for Medical Research

Dr. Brennan is the immediate past president of the NY Metropolitan Chapter of the Association of Clinical Research Professionals. She also is on the advisory board of the Westchester Biotech Project. She is an active member of the Clinical Trial Transformation Initiative (CTTI), with Duke University and the FDA, where she sits on some of their committees. She sits on the oncology advisory board and technology site advocacy group with the Society for Clinical Research Sites (SCRS) and is a member of DIA, the Regulatory Affairs Professional Society, Women in Bio, and the American College of Healthcare Executives.

Jasmine Benger

Senior Project Manager, Research Services
CISCRP

Responsible for supporting the design, implementation, analysis and reporting of a variety of CISCRP research studies including the Perceptions and Insights studies, numerous patient advisory boards, and workshops. Prior to CISCRP, worked in public health for over five years specifically with maternal and child populations in a variety of capacities.

Ben Hargreaves

Editor
in-PharmaTechnologist and BioPharma-Reporter

Ben is the editor of in-PharmaTechnologist and BioPharma-Reporter, covering the latest stories and topics concerning the industry. Prior to working in his current position, Ben worked as deputy editor at Pharmafile.

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