THOUGHT LEADERSHIP

The top priority of a Clinical Research Organization (CRO) is to help a sponsor conduct a successful clinical trial. That success is measured in data quality, process efficiency, and cost effectiveness.

Clinical trials leverage the expertise of people in a wide variety of roles — researchers, project managers, clinical data managers, etc. One of the positions with which people may be less familiar is that of the clinical research associate (CRA).

This trial is particularly interesting, given the recent US Food and Drug Administration (FDA) approval of KEYTRUDA® (pembrolizumab; Merck), the first approved cancer therapy for solid tumors based on common genetic markers as opposed to initial location of the tumors.

Clinical research is a discipline that is constantly evolving. Currently, the most rapid innovation is occurring in the use of mobile health technology (or mHealth).

In “After 40-year odyssey, first drug for aggressive MS wins FDA Approval,” (Stat News, March 28, 2017), Ron Winslow describes the fascinating journey of Roche’s new multiple sclerosis (MS) drug to obtain US Food and Drug Administration (FDA) approval.