BIO International Convention

Nancy Kivel, M.D.

Senior Vice President, Medical Sciences

Tuesday, June 17th from 11 - 12 p.m.
Title – “Patient-reported Outcomes are Front and Center for Drug Development and with the FDA and the CDC”

Women on social media sites (TikTok) have been speaking out about IUD pain, with some describing the procedure as “the worst pain imaginable” or saying they “almost passed out.” Duke University researchers reviewed the top 100 videos and found that 96.8% highlighted pain and some (27.6%) mentioned distrust of healthcare professionals. These TikTok videos get over 1.4 billion views. Welcome to new style of patient-reported outcomes! Patient’s voices are ““viral” on social media. This public outcry from women, along with seminal articles in the New York Times and Wall Street Journal, has prompted the CDC to issue updated guidelines advising doctors to counsel their patients before IUD insertion about what to expect and what their options are for pain management. This session will include a discussion of a case study of IUD insertion pain and answer the question of how to identify and address patient concerns, how patient concerns can change medical practice, and how to build patient-reported outcomes into a clinical development program.

Panelists
Nancy Kivel, Senior Vice President, Medical Sciences, Parexel
Mary Beth Cicero, MBA, Founder & CEO, 3Daughters, Inc.
Aaron Lazorwitz, MD, PhD, Assistant Professor, Div. of Complex Family Planning & Reproductive Sciences, Yale University School of Medicine

Room254B