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  • Pauline Lavigne

Operational Shifts in Trial Conduct: Lessons Learnt From The COVID-19 Crisis

Friday, December 4th: 7:00 – 9:00 pm

The COVID-19 pandemic has affected almost every aspect of daily life for the majority of people on this planet. Cardiovascular trialists and the patients we enrol in our trials are no exception.

This session, co-chaired by a cardiologist, Dr. Gail Pearson, and an industry representative, Dr. Monica Shah, will provide diverse perspectives on strategies to adapt clinical trial operations during this health crisis. Dr. Gail Pearson is an associate director of Cardiovascular Sciences, and director of the Adult and Pediatric Cardiac Research Program at the National Heart, Lung, and Blood Institute (NHLBI), USA. Dr. Monica Shah is Vice President of Medical Strategy at IQVIA Inc., USA.

This is a vital session for anyone that is facing the challenges of continuing a clinical trial that is already underway, or is confronted by the potential loss or delay of an upcoming planned trial. Maintaining follow up, continuity, and data integrity are just some of the challenges. Concerns in the past about standardization of lab testing, imaging procedures, and drug administration, at remote sites frequently resulted in the use of a limited number of certified centralized trial sites. This often led to hardships for many patients who may have to travel substantial distances. Conversely, other patients will now miss the closer follow up, and human contact. What impact will these factors have on clinical trial results, and how comparable will trials done in today’s environment be to those in the past?

During this session learn new ways to tackle enrolment challenges and provide support to trial participants, way of shifting from clinic visits to home-based testing, the quality and cost-effectiveness of wearable devices and remote monitoring, and the safe incorporation of home nursing and decentralized follow-up staff into CV trials. There are critical questions around endpoint collection and adjudication. Should we increase our reliance on public records and registries to assess outcomes in CV trials? What new parameters and standards do we need for Clinical Endpoint Committees?

Additional speakers include: Mintu Turakhia (Stanford, USA), David McManus (Worchester, USA), Jodi Akin (Hawthorne Effect, USA), Sadegh Alikhaani (Los Angeles, USA), Penilla Gunther (Stockholm, SWE), Stefan James (Uppsala, SWE), and Peter Carson (Chapel Hill, USA).

You will want to stay tuned after the presentations for the moderated multi-stakeholders debate. The panel includes cardiologists, members of industry, and regulatory bodies, as well as editors of prestigious medical journals. The discussion is sure to provide unique strategies and perspectives for overcoming many of the challenges of designing, conducting, and publishing clinical trials during the COVID-19 pandemic. Logon and take advantage of the experiences of others.

Making CV Precision Medicine Become a Reality

Thursday, December 3rd: 7:30 – 9:30 pm Advances in disease stratification tools, such as molecular and imaging technologies, will help to identify more specific patient populations. This will help to


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