Participation is Personal: Community Outreach Impacts Clinical Trial Diversity

Participation is Personal: Community Outreach Impacts Clinical Trial Diversity By Kathleen Hoffman, PhD, MSPH Despite FDA policy initiatives over the last few decades, certain groups continue to be unnecessarily underrepresented in many clinical trials.1 The Yale Center for Clinical Investigation (YCCI) at the Yale School of Medicine is tackling this problem with local resources. Since its inception in 2005, part of YCCI’s mission has been to: “...Strengthen the infrastructure that connects clinical research teams with practitioners, community health clinics, and community stakeholders throughout Connecticut, reaching out in particular to diverse populations including children, women, the elderly, [...]

Federal Agency Perspectives on Clinical Trial Eligibility: Spring 2018

Federal Agency Perspectives on Clinical Trial Eligibility: Spring 2018 “Most current [breast cancer] clinical trials only enroll what I call the metastatic cancer ‘Olympians:’ the healthiest of the dying, those who are on their first or second line of therapy, who have limited metastases, who don't have brain mets, who don't have other diseases like diabetes or high blood pressure,” Dr. Kelly Shanahan, an obstetrician-gynecologist, activist, consumer reviewer for the Department of Defense Cancer Research Program and patient with stage 4 breast cancer said in an interview via email.1 Dr. Shanahan’s description matches many of the concerns [...]