The Clinical Trials Transformation Initiative (CTTI) sponsors a Public Summit: The Fastest Path to Effective COVID-19 Treatments: Using Master Protocol Studies. CTTI, a prominent and influential public-private partnership co-founded by the U.S. Food and Drug Administration (FDA) and Duke works to identify and promote practices that will increase the quality and efficiency of clinical trials. They invite those interested in COVID-19 clinical research to participate in an important forthcoming Webinar on January 13th, 10:30AM ET. Speed is of critical importance in the development of drugs and during the pandemic exponentially more so. Over 370,000 people have died in the United States; nearly 2 million worldwide and there are still no approved early treatments for the new disease here in the United States. Joining CTTI lead Pamela Tenaerts, https://www.linkedin.com/in/pamelatenaerts/ brings in some industry heavy-hitters to discuss this mission-critical topic of Master Protocol Studies as a means to develop more treatments, faster. Janet Woodcock, Director, Center for Drug Evaluation and Research, FDA; Detail, Operation Warp Speed (OWS) offers an important welcome followed by “a call-to-action from Robert M. Califf, MD, with Verily and Google Health as well as Duke; Mark McClellan with Duke-Margolis Center for Health Policy offers important perspective followed by a panel discussion moderated by Esther Krofah with FasterCures, part of the Milken Institute.
With an emphasis on solutions, the panel discussion covers important material associated with the scaling of master protocols including:
· Overcoming barriers to starting up sites
· Increasing participants at existing sites
· Using the COVID experience to inform preparedness for future pandemics
Why this Webinar?
CTTI and the clinical research industry, that is academic medical centers, pharmaceutical companies, regulatory and government research agencies, non-profit research institutes, health systems and hospitals as well as research sites and non-profit research institutes, have learned a great deal in this global pandemic. Importantly, “the faster we have reliable answers, the better.” CTTI shares that the need for collaboration in research has never been greater. They suggest that at least in many relevant cases master protocol studies can provide intriguing solutions.
The public summit was also designed to address the status COVID-19 clinical trials, including results from a recent CTTI analysis of data from Clinicaltrials.gov and other research; they will examine the use of common platforms to optimize the design of master protocols for multiple therapies in an effort to treat the same diseases or specific health problems.
What is a Master Protocol?
Master protocols represent how clinical trials are morphing in dynamic and progressive directions. They include a number of approaches including platform, umbrella, and basket clinical trial designs. Traditionally used more frequently in oncology, they are showing up in more therapeutic areas especially with the emergence of COVID-19. This class of clinical research evolved to help researchers more efficiently overcome challenges associated with the mission to determine which therapy or combination of drugs would produce the best response in diseases with heterogeneous patient populations. Or in situations where researchers face multiple possible therapeutic options. Introducing unique and malleable designs, they can include biomarker development, genetic subtyping and therapies with varying mechanisms of action.
According to the FDA, Master Protocol design is but one example of the innovative regulatory approaches resulting from the 21st Century Cures Act—they are contributing to the ongoing modernization of drug development.
Jan 13, 2021 10:30 AM Easter Time (US and Canada)
Call to Action: Register for this important Webinar here. Webinar Registration – Zoom