Workshop IV

Challenging Dogma: Creating a New Generation of Efficacious Biomarker-Driven Clinical Trials.
February 3-4, 2014 
The Royal Palms Resort and Spa

Biomarkers are key in the design, implementation and ultimate success of clinical trials for interventions that are intended to diagnose and/or treat disease.  The randomized control trial has been the “gold standard” for the last several decades.  The U.S. FDA and most international regulators employ this model today – essentially unchanged since the early 1990’s introduction in its present form. The U.S.Food and Drug Administration (FDA, and most international regulators have employed this model nearly unchanged since its introduction.  Unfortunately, too many clinical trials fail at great costs in both time and resources.  As a result, it costs well over 1 billion dollars to develop a drug today – and the situation is unlikely to change unless there are fundamental changes in biomarker research and development.

We stand at a point in biomedicine where advanced technologies promise to enable measuring changes in normal or disease processes (biomarkers) to improve the success of clinical trials performed in complex diseases such as cancer.  This NBDA workshop, “Challenging Dogma:  Creating a New Generation of Efficacious Biomarker-Driven Clinical Trials", comprised of experts from the private, academic, government and advocacy sectors, focused on understanding why clinical trials fail.  The group further explored a number of “big ideas” of how to “fix” many of the problems that doom clinical trials to failure by improving biomarker research and development. (Biomarkers can serve as companion diagnostics, prognostics markers or patient stratification tools).  The workshop also carefully analyzed the I-SPY 2 trial, which integrates both established and exploratory biomarkers in its adaptive design.   

This information will be available in Spring 2016 to those individuals and organizations that join the NBDA as Partners, Collaborators or Members.

Workshop IV