An extraordinary amount of global research is underway as the COVID-19 pandemic continues to evolve and spread throughout the world. There are over 800 registered global clinical trials taking place to develop life-saving treatments and vaccines for patients. The World Health Organization is also facilitating collaboration and accelerated efforts on an unprecedented scale. In these difficult times, sponsors must utilize innovative tools and approaches to design their clinical trials in order to provide promising results for all patient populations as quickly and efficiently as possible.
A successful virtual panel discussion was conducted by Cytel on the ongoing COVID-19 Trials, on April 15. For the second complimentary virtual panel discussion held on April 23, Cytel partnered with Certara, to present, “COVID-19: Trials, Designs and Tools for Promising Results”. It began with challenges faced by clinicians and drug developers, followed by examples of tools and trial designs currently being used to help sponsors of COVID-19 trials. Continue reading for a summary of the panel discussion.
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Panelist, Srinivas Murthy, MD. Critical Care Physician, University of British Columbia and Co-Chair SOLIDARITY trial from WHO, spoke about two ongoing and actively recruiting trials, being conducted in several geographies. During his presentation, he briefed us on Randomized, Embedded, Multifactorial Adaptive Platform trial for Community-Acquired Pneumonia (REMAP-CAP) and the WHO Solidarity Trial. REMAP-CAP uses a novel and innovative adaptive trial design to evaluate a number of treatment options simultaneously and efficiently. It is currently recruiting in over 50 sites worldwide. Dr. Murthy then gives an overview on "Solidarity”, an international clinical trial to help find an effective treatment for COVID-19, launched by the World Health Organization and partners. It is a global ‘megatrial’ with the aim of enrolling (tens of) thousands of patients with a common analytic set and common randomization scheme.
The next speaker, Dr. Craig Rayner, President, Certara, takes us through five lessons that we have learned from our past experiences in dealing with therapeutics in pandemic circumstances. He emphasizes the importance of understanding what we are up against and stresses on the need for smarter drug development to accelerate therapeutics for COVID-19. He also raises a critical question of finding the optimal dose regimen and explains the “science” of dosing.
On April 8, Cytel launched the Global COVID-19 Trial Tracker, a tool that consolidates data from trials across the world to illustrate the current clinical development status for COVID-19 therapies. Louis Dron, Director, Cytel, demonstrates how the website can be used by researchers, policymakers, clinicians, journalists, philanthropists, and other critical stakeholders who need to understand the complex dynamics of the global response to finding a solution to the COVID-19 outbreak. He also takes us through the trends observed with the help of this tracker.
The final panelist, Kristian Thorlund, SVP, Cytel, talks about the innovative trial designs that can be used during the COVID-19 pandemic, for promising results. He looks at the 15 most investigated treatments and makes observations that can help set the roadmap to appropriately design clinical trials. He also talks about how the adoption of Master Protocols, including Basket Trials and Umbrella Trials, and Platform Trials has increased over the last two decades. Kristian gives us examples of registered master protocols in COVID-19 and speaks about the significance of these trial designs that will continue even after the pandemic subsides.
Watch the replay of this insightful COVID-19 Panel discussion and download the slides.
The next virtual panel discussion in the COVID-19 series is on the topic New Opportunities & Implications for the Future of Drug Development in Emerging Economies and it will be presented by a distinguished panel of external industry thought leaders today, Thursday, May 7.
Can COVID-19 create new opportunities for drug development in emerging economies? Join Trevor Mundel, Bill & Melinda Gates Foundation, Derek Angus, University of Pittsburgh and James Orbinski, York University as they explore this topic. Register now to join and/or get access to the replay and slides.