Thursday, December 3rd: 3:30 – 5:30 pm
The COVID-19 pandemic has important implications for the safety of participants in clinical trials, for the research staff caring for them, and for the on-going conduct and integrity of the clinical trials themselves. Patients with CV diseases are at increased risk of poor outcomes associated with being COVID-19 positive. However, these patients are also at risk of adverse outcomes if their general CV care, or their trial-related care are compromised. As physicians and clinical trialists, it is our responsibility to ensure safe and effective care is delivered to trial participants without affecting the integrity of the study. The social contract with our patients demands no less.
This session will be chaired by Prof. Stefan Anker, from the Division of Cardiology and Metabolism-Heart Failure, Cachexia and Sarcopenia at Charité-Universitätsmedizin Berlin, in Berlin, Germany, and Dr. Monica Shah, Vice President of Medical Strategy at IQVIA Inc., USA. The session will highlight the challenges that this pandemic poses for the conduct of clinical trials in CV disease and offer advice on how they might be overcome, with some practical examples.
This session will review the many guidance statements from regulatory authorities around the world, as well as global panels regarding the conduct of clinical trials during this COVID-19 crisis. Learn how to ensure the safety of participants and the integrity of the trials during this disruptive time. We are increasingly seeing reports of clinical trials that were affected by the COVID-19 pandemic, particularly with regard to close-out visits and data validation processes. What is the impact on the data and safety monitoring committee (DSMC), the institutional review boards (IRBs), and the statistical analyses. How do we deal with missing data, changes in data collections methods, drop outs, and temporary drug discontinuation? Dr. Adrian Hernandez (Durham, USA) will present the experience at the Duke Clinical research Institute as a case study in going forward peri-to-post COVID-19. Regulatory guidance and industry (J&J, Bayer, Amgen, Medtronic, Boehringer Ingelheim, and Sanofi) case studies will also be presented.
Other speakers include Jeffrey Borer (New York, USA), Yves Rosenberg (NHLBI, USA), John Gregson (London, England), Fred Senatore (FDA, USA), as well as our patient trialists (Nick Hartshorne-Evans, Pumping Marvellous Foundation, London, GBR, and Greg Merritt Ann Arbor, USA)
Stay for the moderated, multi-stakeholder, expert panel debate where we will exchange experiences and ideas on how to target the problems of every-day clinical trial conduct, analysis, and reporting. With “self-isolation” and “social distancing” the new normal this is a must-see session, with participants from academia, clinical practice, industry, regulatory agencies, and publishing providing a myriad of viewpoints.