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 )