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International Clinical Trials

The New Imperative

The social media revolution has created opportunities for communication in all aspects of life, including clinical research. It provides new ways for patients to gain information related to medical care and connect with other patients and support networks. Clinical trial advertising and associated regulations are changing rapidly; print advertising has been on a steady decline, while online advertising continues to grow as more and more companies see the value and potential to reach large numbers of patients via the internet. For ultra-rare and rare disease researchers, the geographic reach and capabilities for targeted messaging present new means of accessing patients worldwide. As social media becomes a primary resource for global communication, the opportunities available to research organisations are too compelling to be ignored. Sponsors and research organisations must address the reality of social media from an information management perspective in order to preserve the systems and protocols that maintain the integrity of drug development processes.

From a regulatory standpoint, the FDA has responded to aspects of social media use with respect to clinical trials. These draft guidance documents, released in 2011 and 2014, address the presentation of benefit and risk information within the character limitations on various digital platforms, the correction of third-party misinformation related to prescription drugs and medical devices, the fulfilment of regulatory requirements for postmarketing submissions of interactive promotional media for prescription human and animal drugs and biologics, and the methods of responding to unsolicited requests via social media for off-label information on prescription drugs and medical devices. These seminal documents do not fully address the ways in which current social media engagement by patients and other stakeholders can affect the execution of clinical trials and the regulatory viability of resulting study data.

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About the author

Barbara Zupancic
is the Senior Director, Patient Recruitment and Retention, at Worldwide Clinical Trials. Barbara has over 15 years of experience in clinical research, specifically focused on patient recruitment and feasibility. Passionate about engaging patient volunteers to better the lives of many, Barbara has spent countless hours in the field working with various types of research sites and patient groups. Barbara’s passion is in the rare disease arena as well as CNS, specifically Alzheimer’s disease. She is a frequent speaker at conferences, has conducted numerous webinars, and is a published author. Barbara has a Bachelor of Science in Psychology, Masters of Science in Counseling Psychology and Research, and an MBA in Management.
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