How will the removal of requirement for CVOTs from FDA shape the future of trial design?
Friday, December 4th: 1:30 – 3:30 pm
How will the removal of requirement for cardiovascular outcome trials (CVOTs) from the 2020 FDA diabetes guidance shape the future of trial design?
The FDA’s draft guidance, “Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control,” removes the more than a decade old requirement for cardiovascular outcome trials (CVOTs) for antidiabetic drugs. Put in place because of concerns about thiazolidinediones, CVOTs reviewed since 2008 have not identified increased CV risks, and in fact some have demonstrated a reduced risk for CV events. The new guidance also requires increased inclusion of older subjects and those with chronic kidney disease who may be more susceptible to drug-related side effects.
This session is chaired by Dr. John Cleland, Director of the Robertson Centre for Biostatistics and Clinical Trials, at the University of Glasgow, GBR, and Dr. Lynne Stevenson, Director of Cardiomyopathy and the Advanced Heart Disease training program, at Vanderbilt University Medical Center, Nashville, USA.
What impact will this have on current and future trials conducted in the diabetic population, patients at high risk for CV and other negative outcomes? Join this session to learn more about the repercussions of this change for trialists, patients and from a medico-legal perspective. We will hear viewpoints from a cardiologist, a diabetologists, a nephrologist, a lawyer, a patient, representatives of the pharmaceutical industry, and members of US and European regulatory agencies.
Speakers include: John Cleland (Glasgow, GBR), Thomas Zelniker (Boston, USA), George Bakris (Chicago, USA), Josephine M Torrente (Hpm, USA), Jacqueline Alikhaani (Los Angeles, USA), Susan Quella (Rochester, USA), Graziella Collu (AstraZeneca, SWE), Waheed Jamal (Boehringer, GER), James John-Paul Lock (Theracos, USA), James Revkin (Pfizer, USA), Jeffrey Riesmeyer (Lilly,USA), Norman Stockbridge (FDA, USA), and Angeles Alonso (MHRA, GBR).
The post-session moderated multi-stakeholder expert panel debate, titled, “Interpreting the results of SGLT2 inhibitors diabetes, HF and CKD trials” will use examples to put the new guidance in context. With such a diverse cast of characters, I’m sure the discussion will be a lively one. No virtual fist fights please.