Medication non-adherence in clinical trials can lower the statistical power of the study, leading to incorrect conclusions about the safety and efficacy of novel treatments. A recent study by the Tufts Center for the Study of Drug Development reviewed over 250,000 dosing videos captured by the AiCure platform, showing approximately half (48%) of all study volunteers had at least one intentionally non-adherent dose. Apart from concerns about the underestimation of the true dose response, toxicity and the overestimation of the optimal dose level required, new questions arise around the ability of trial investigators to predict patient behavior and factor it into analysis.
In this webinar, Rich Christie, MD, PhD, from AiCure, Ken Getz from the Tufts Center for the Study of Drug Development and Dooti Roy, PhD, from Boehringer Ingelheim, will discuss patient dosing patterns and how to apply predictive dosing to improve the effectiveness of clinical trials. Register for this webinar to hear their novel insights.
Rich Christie, MD, PhD, Chief Development Officer, AiCure
As Chief Development Officer at AiCure, Rich oversees the commercial development, sales and marketing of AiCure’s offerings. Previously, Rich served as Global Head, Development Science and Innovation at Roche, and as Vice President, Business Development in the M&A group of Johnson & Johnson. He was also the CEO of Solaris Therapeutics, a start-up developing small molecule inhibitors of E3 ligases, out of Columbia University.
Prior to his time in pharma, Rich spent 3 years at McKinsey & Co., serving the pharmaceutical, biotechnology and services sectors as an Engagement Manager and a year at Caxton Health Holdings, a healthcare-dedicated investment firm. Rich received an SB from MIT and an MD/PhD from Harvard, where he patented and developed novel optical methods for the study of Alzheimer’s disease.
Dooti Roy, PhD, Principal Methodology Statistician, Boehringer Ingelheim
Dooti is a statistician and researcher who enjoys solving complex problems to make clinical trials efficient in dynamic, cross-functional environments.
Ken Getz MBA, Director & Professor at Tufts Center for the Study of Drug Development, Tufts University School of Medicine
Ken Getz is the Director and a professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine, where he conducts grant-funded research on pharmaceutical R&D management and execution; protocol design optimization; contract service provider and investigative site management; eClinical technology; data usage; and patient engagement.
He is the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical research enterprise. A well-known speaker at conferences, symposia, universities, investor meetings and corporations, Ken has published extensively in peer-review journals, books and in the trade press and writes a bi-monthly column nominated for a Neal Award in Applied Clinical Trials.
He holds a number of board appointments in the private and public sectors and serves on the editorial boards of Pharmaceutical Medicine and Therapeutic Innovation and Regulatory Science. Ken received an MBA from the J.L. Kellogg Graduate School of Management at Northwestern University and a bachelor’s degree, Phi Beta Kappa, from Brandeis University. Ken is the founder of CenterWatch, a leading publisher in the clinical trials industry, and one of several businesses that he has created and sold.
Marlen Rattiner, VP, Product Management, AiCure (Moderator)
Marlen is Vice President of Product Management at AiCure. He has over 20 years’ experience managing the launch and product direction for dozens of web and mobile applications. Prior to AiCure, Marlen spent over 10 years working in EdTech and obtained a Master’s Degree in Educational Technology from NYU. He uses his background in educational technology and cognitive science to inform AiCure’s work designing a best-in-class solution for improving patient outcomes while reducing patient burden.
Who Should Attend?
Professionals with responsibility for:
- Data Management
- Information Management
- Clinical Operations
- Digital Innovation/Strategy
- Patient Experience
- Decentralized/Virtual Trials
- Study Design
- Clinical Research
- Clinical Project Managers
- Data Scientists/Biostatisticians
- Safety/Regulatory/Medical Affairs
What You Will Learn
Participants will gain insight into the relationship between:
- Patient Dosing Patterns
- Intentional Non-Adherence
- Trial Efficacy
Join this webinar to learn about best practice guidance for incorporating predictive dosing into the trial protocol.
AiCure is an AI and advanced data analytics company that monitors patient behavior and enables remote patient engagement in clinical trials. AiCure improves predictability of study timelines, reduces costs and accelerates timelines through remote patient engagement and assessments, including measuring digital biomarkers and real-time monitoring of patient dosing. Founded in 2010 and funded by the National Institutes of Health (NIH) and leading institutional investors, AiCure has more than 65 issued patents and works with global clients in over 30 countries. AiCure is globally recognized and is a recipient of the Scrip Award, AI 100 and Digital Health 150. For more information, please visit www.aicure.com
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