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#PatientVoiceMatters: How Social Media Is Bringing Patients and Biopharmaceutical Companies Together to Improve Drug Development

      Before the 1990s, the voices and perspectives of patients were largely excluded from drug development.
      • Bergner M.
      Quality of life, health status, and clinical research.
      Throughout the 1990s and 2000s, the industry saw a flurry of patient-centric activity, possibly due to regulatory agencies’ increasing interest in the voice of the patient.

      Stadler M. A Short history of patient centricity. https://www.clariness.com/blog/a-short-history-of-patient-centricity. Accessed October 10, 2017.

      In 2006, the US Food and Drug Administration (FDA) drafted guidance on the use of patient-reported outcomes for labeling claims.
      US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health. Guidance for Industry. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. Drafted February 3, 2006. Published December 9, 2009.
      Today, the patient perspective has emerged as an integral component of drug development and patient labeling, in addition to the assessment of long-term health outcomes. As FDA Commissioner Scott Gottlieb stated at his 2017 inaugural address, “[w]e need to be patient-centric and science-based in everything we do,”

      Gottlieb S. First Remarks to FDA staff. https://www.fda.gov/NewsEvents/Speeches/ucm558566.htm. Published May 15, 2017. Accessed October 10, 2017.

      thereby emphasizing the FDA’s commitment to incorporating the patient voice in drug and device development. Further demonstrating the FDA’s commitment, the Center for Devices and Radiological Health created a patient engagement advisory committee composed of patients and patient advocates. The patient engagement advisory committee is a “forum for the voice of patients”

      O'Callaghan K, Shuren, J. FDA Sets Inaugural Meeting of First-Ever Patient Engagement Advisory Committee. https://blogs.fda.gov/fdavoice/index.php/2017/07/fda-sets-inaugural-meeting-of-first-ever-patient-engagement-advisory-committee/. Published July 25, 2017. Accessed October 10, 2017.

      focused on all aspects of device development, ranging from clinical trial design to regulatory requirements.

      O'Callaghan K, Shuren, J. FDA Sets Inaugural Meeting of First-Ever Patient Engagement Advisory Committee. https://blogs.fda.gov/fdavoice/index.php/2017/07/fda-sets-inaugural-meeting-of-first-ever-patient-engagement-advisory-committee/. Published July 25, 2017. Accessed October 10, 2017.

      The Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research continue their efforts with the patient-focused drug development program.

      Hunter N, Califf RM. Why Partnerships are Key to the Science of Patient Input. https://blogs.fda.gov/fdavoice/index.php/tag/the-patient-focused-drug-development-pfdd-program/. Published October 2, 2015. Accessed October 10, 2017.

      Biopharmaceutical companies have also embraced patient-centricity in drug development.
      • Getz K.
      Establishing Return-on-Investment Expectations for Patient-Centric Initiatives.
      In an effort to incorporate the patient voice in drug development, biopharmaceutical companies have increased the use of patient-centric initiatives, for example, creating patient advisory boards,
      • Anderson A.
      • Getz K.A.
      Insights and Best Practices for Planning and Implementing Patient Advisory Boards.
      working with patient advocacy groups to define meaningful patient outcomes,
      • Ellis L.E.
      • Kass N.E.
      How are PCORI-funded researchers engaging patients in research and what are the ethical implications?.
      and adopting mobile health technologies.
      • Zhang J.
      • Sun L.
      • Liu Y.
      • et al.
      Mobile Device-Based Electronic Data Capture System Used in a Clinical Randomized Controlled Trial: Advantages and Challenges.
      Additionally, biopharmaceutical companies have increased their use of social media in all aspects of drug development, such as recruiting patients directly into clinical trials,
      • Krischer J.
      • Cronholm P.F.
      • Burroughs C.
      • et al.
      Experience With Direct-to-Patient Recruitment for Enrollment Into a Clinical Trial in a Rare Disease: A Web-Based Study.
      • Jones R.
      • Lacroix L.J.
      • Porcher E.
      Facebook Advertising to Recruit Young, Urban Women into an HIV Prevention Clinical Trial.
      listening to patients discuss disease symptoms most relevant to them,

      Lamberti MJ, Stergiopoulos S, Naik P, Getz KA. Industry Usage of Social and Digital Media Communities in Clinical Research. A Tufts Center for the Study of Drug Development White Paper [Electronic White Paper]. http://csdd.tufts.edu/files/uploads/TCSDD_Social_Media_Final.pdf. Published June 2014. Accessed June 2014.

      • Ji X.
      • Chun S.A.
      • Cappellari P.
      • Geller J.
      Linking and using social media data for enhancing public health analytics.
      gathering feedback from patients on clinical trial protocol design,
      • Tricco A.C.
      • Zarin W.
      • Lillie E.
      • et al.
      Utility of social media and crowd-sourced data for pharmacovigilance: a scoping review protocol.
      and capturing adverse event information for signal detection.
      • Naik P.
      • Umrath T.
      Stekelenborg Jv, et al. Regulatory Definitions and Good Pharmacovigilance Practices in Social Media.
      • Vilar S.
      • Friedman C.
      • Hripcsak G.
      Detection of drug-drug interactions through data mining studies using clinical sources, scientific literature and social media.
      In this issue of Clinical Therapeutics, we highlight the important role that social media plays in bringing the patient voice into drug development. In their Original Research article, Dr. Mary Jo Lamberti and Josephine Awatin summarize the current state of patient-centric initiatives across pharmaceutical, biotechnology, and contract research organizations.
      • Lamberti M.J.
      • Awatin J.
      Mapping the Landscape of Patient-centric Activities Within Clinical Research.
      The results of their global, industry-wide survey reveal the types of patient-centric activities that have been adopted, and offer insight into the barriers and challenges that remain. Many of these activities involve social media, including a high-ranking initiative to establish patient communities. In an accompanying Commentary, Amrutha Anand and colleagues describe how HealthUnlocked, one such health-focused community and online social network, has been leveraged to increase patient involvement across all stages of drug development.
      • Anand A.
      • Brandwood H.J.
      • Evans M.J.
      Improving Patient Involvement in the Drug Development Process-Case Study of Potential Applications from an Online Peer Support Network.
      Case examples are given to demonstrate how online health networks can be used to incorporate patient feedback into clinical trial design, recruit and screen patients for clinical trials, and conduct online longitudinal research studies.
      The utility of patient communities is echoed in Laura Housman’s Commentary, in which she introduces readers to the vast opportunities that have been enabled by the rapid growth of social media, mobile devices, and mobile health applications.
      • Housman L.T.
      "I'm Home(screen)!": Social media and mobile applications in healthcare have arrived.
      Ms. Housman’s role as Senior Vice President at MolecularHealth and her previous role in the Market Access, Pricing, and Health Economics and Outcomes Research Group within the Molecular Diagnostics Unit at Novartis Pharmaceuticals have provided her with a unique view on industry social media strategies for drug development. Her Commentary provides an overview on how industry has been using social media to aid patients in disease management, to learn about the patient experience through online communities and social listening, and to recruit patients into clinical trials.
      Despite early signs of success in using social media for patient recruitment, Dr. Ken Getz suggests that social media is currently underutilized by health care professionals relative to other clinical trial referral practices. In his Original Research article, a survey of more than 2000 doctors and nurses revealed a low referral rate, despite a desire to connect patients with available clinical trials.
      • Getz K.
      Examining and Enabling the Role of Health Care Providers as Patient Engagement Facilitators in Clinical Trials.
      He proposes that there is a gap in information sharing between practitioners and patients that can be bridged by social media, by both connecting patients with clinical trials and educating practitioners about clinical trial opportunities to discuss with their patients. There is an even greater need for improved enrollment and recruitment practices in trials for orphan diseases. As discussed by Dr. Chris Milne, breakthroughs in rare and orphan diseases are urgently needed, but are slowed by challenges such as low disease prevalence, disease heterogeneity, and wide geographic spread. Dr. Milne provides a balanced view of the opportunities and caveats for social media approaches in orphan drug development, highlighting social media’s role in patient-centric communication, patient education, and in increasing awareness of the orphan disease.
      • Milne C.
      The Use of Social Media in Orphan Drug Development.
      Although industry and regulatory agencies have been increasing use of social media in drug development, using and reporting adverse event information from social media websites remains controversial.
      • Naik P.
      • Umrath T.
      Stekelenborg Jv, et al. Regulatory Definitions and Good Pharmacovigilance Practices in Social Media.
      The FDA has provided draft guidance on presenting benefit−risk information on social media platforms,
      US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Veterinary Medicine, Center for Devices and Radiological Health. Guidance for Industry: Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices. Drafted June 18, 2014.
      correcting third-party misinformation,
      US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Veterinary Medicine, Center for Devices and Radiological Health. Guidance for Industry. Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices Draft Guidance. Drafted June 18, 2014.
      and fulfilling regulatory requirements for postmarketing submissions.
      US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Veterinary Medicine. Guidance for Industry. Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics. Drafted January 2014.
      However, more clarification and guidance for adverse event reporting and information is needed.
      On September 7, 2017, Facebook held a breakfast for biopharmaceutical companies that focused exclusively on clinical trial recruitment.

      Farr C. Facebook held a special breakfast for drug marketers about recruiting people for clinical trials. https://www.cnbc.com/2017/09/07/facebook-held-a-breakfast-to-promote-clinical-trials-strategy.html. Published September 7, 2017. Updated September 8, 2017. Accessed October 10, 2017.

      No longer seen as strictly a conduit for digital advertising, social media is now viewed as a tool that biopharmaceutical companies use to listen to, engage, and collaborate with patients to improve drug development. The articles included in this Specialty Update report on industry best practices and opportunities for use of social media, thereby aligning industry with FDA in being patient-centric in everything they do to improve drug development.

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