Published Mar 9, 2015

Raritan, NJ, USA - A collaboration designed to open dialogue between industry and government leaders has found “great potential” for social media to support content validity of patient-reported outcomes (PRO) instruments, and outlined how the use of social media can create more diverse and cost effective data collection. The collaborator’s discussions are highlighted in a new paper titled, “Can We Use Social Media to Support Content Validity of Patient-Reported PRO Instruments in Medical Product Development?” The paper has been made available for free in Value in Health, the official journal of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Written by a team of nonprofit, private industry and government officials, the paper addresses an issue that has received little attention in the scientific literature: how to collect data that supports content validity in a way that is acceptable for regulatory use in pharmaceutical labeling. The growth of social media in health care has spurred interest in the topic. As more patients share their health experiences online, the Internet has emerged as a new foundation for developing and validating new PROs because researchers can more easily target and engage patient populations online than with traditional methods such as face-to-face or telephone interviews. The paper compares various approaches to collecting and analyzing data and outlines a vision of how social platforms could accelerate PRO development and lead to reliable instruments. It also stresses the need to develop additional empirical evidence to answer questions about how populations are recruited and represented, and which types of social media are most appropriate for data collection. The paper’s authors include: Ari Gnanaskathy, Head of Patient-Reported Outcomes at RTI Health Solutions; Elektra J. Papadopoulos, MD, MPH; Study Endpoints and Labeling Development (SEALD); Study Endpoints team in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA); Margaret Rothman, PhD, CEO, Rothman Associates Consulting; and Paul Wicks, PhD, Vice President of Innovation at PatientsLikeMe. Contact Margot Carlson Delogne PatientsLikeMe mcdelogne@patientslikeme.com 781-492-1039

###