The ability to efficiently develop new medicines for patients with unmet needs is limited by the current model for clinical development. Fundamentally, the conduct of clinical trial has not changed significantly over the last few decades. Emerging digital and mobile health technologies have the potential to improve the conduct of clinical trials, allowing for more efficient development of new medicines for patients. Seeking patients’ input into the design and conduct of clinical trials is now possible via mobile devices, sensors and remote technologies that can enhance recruitment, retention, adherence and clinical endpoint measurement. Data and experiences from a number of clinical studies will be summarized, highlighting the opportunities and challenges in this new area of clinical development.
Michelle Crouthamel is the digital platform leader of the Clinical Innovation Unit at GlaxoSmithKline (GSK). Michelle’s passion for driving patient-centricity in the pharmaceutical industry led her to become an ‘Intrapreneur’ at GSK, and the founding member of the Clinical Innovation Unit, which focuses on harnessing digital technologies and platforms to improve patient engagement and clinical trials. Michelle is currently leading the strategy and pilot programs of e-Recruitment and m-Health platforms, and is involved in the industry-wide consortium, TransCelerate, eSource work stream. Over past 15 years, Michelle led many successful programs in discovery and development at both Merck and GSK, is an inventor who holds multiple patents, and has published extensively in the areas of Neuroscience, Oncology, and Digital Health.
Michelle has a Master’s degree from the Institute of Neuroscience, and a Bachelor’s degree in Nursing from the National Yang-Ming University, Taiwan. She is currently pursuing a doctoral degree at Fox Business School, Temple University with a research focus on the Patient-Centricity in the pharmaceutical industry.