We anticipate that in 2020 we will see an acceleration of existing trends that challenge our conventional approaches towards evidence generation, clinical trials and research priorities.
The traditional paradigm of very large and costly clinical trials that often yield incremental benefits for select patients is no longer tenable in the current healthcare environment. As such, innovative strategies that curate and link existing data repositories will prove increasingly valuable by enabling clinicians, investigators and other stakeholders to not only ask meaningful questions but also do so in a rapid and cost-effective fashion.
A shift towards clinical studies that are designed to address patient-reported and centered outcomes, such as quality of life, will also continue and increase in importance as compared with traditional “hard” outcomes.
Finally, innovation in the cardiovascular space must be coupled to a reduction in overall cost, or alternatively a gain in value within an acceptable cost, in order to gain broad acceptance by clinicians and third-party payors. The reduction in price for the PCSK9 inhibitors is an example of this “value-based” reality and we expect this will continue in the coming years.
The Changing Paradigm
Roxana Mehran, MD
Usman Baber, MD
By Roxana Mehran, MD & Usman Baber, MD ( Mount Sinai School of Medicine )
Roxana Mehran, MD, FACC, FACP, FCCP, FESC, FAHA, FSCAI is Professor of Medicine and Director of Interventional Cardiovascular Research and Clinical Trials at the Zena and Michael A. Wiener Cardiovascular Institute at Mount Sinai School of Medicine (icahn.mssm.edu/research/center-interventional-cardiology). Dr. Mehran completed her training in internal medicine at the University of Connecticut, where she was also a Chief Medical Resident, before continuing with Fellowships in Cardiovascular Disease and Interventional Cardiology at Mount Sinai Medical Center. Dr. Mehran is internationally recognized for her work as a clinical trial specialist with complex data analyses and outcomes research within the field of interventional cardiology and for her experience and expertise in working with regulatory agencies to conduct clinical trials.
Her research interests expand from mechanisms of restenosis to treatment and prevention of acute kidney injury in cardiac patients, as well as advancing treatments for acute coronary syndromes and acute myocardial infarction. In addition to founding a highly regarded academic research organization (ARO) within the Cardiovascular Research Foundation, she is also a widely published author and frequent invited speaker at national and international scientific conferences such as American Heart Association, American College of Cardiology, European Society of Cardiology, and EuroPCR. She has served as Course Co-Director of the annual Transcatheter Cardiovascular Therapeutics (TCT) for the last 13 years. Dr. Mehran serves on editorial board of multiple peer reviewed journals, including Journal of the American College of Cardiology, Circulation, and Circulation Research. She currently serves on the board of trustees of SCAI, as a member of the Program Committee for the American Heart Association Scientific Sessions, as a member of the board of directors for Harboring Hearts, and as Program Chair for Society of Cardiac Angiography and Interventions (SCAI- WIN (Women in Innovations)) Initiative, and is also the Chief Scientific Officer of the Clinical Trials Center at the Cardiovascular Research Foundation (NYC).
Dr. Baber, MD is a practicing Interventional Cardiologist in New York, NY. Dr. Baber graduated from University of Texas Southwestern Medical Center Southwestern Medical School in 2004 and has been in practice for 12 years. He currently practices at Mount Sinai Medical Center and is affiliated with The Mount Sinai Hospital and Kingsbrook Jewish Medical Center. Dr. Baber accepts multiple insurance plans including Aetna, Medicare, and Multiplan. Dr. Baber is board certified in Cardiovascular Disease; Internal Medicine. Dr. Baber also practices at Cardio Vascular Institute of Mount Sinai in Brooklyn, NY.