A: OVER 30 YEARS AGO when I began my career, clinical trials were predominately the purview of universities. Now, out of 50 sites in a representative program at my company, only three are academic and only one entered a subject on a study. We tried hard to engage — advisory board involvement, conference meetings, site visits — but simply couldn’t get the university sites open. Reasons included potential IP infringement related to knowledge sharing, contract language stalemate, exorbitant budget requests, Sunshine Act reporting, or simple inertia due to so many other competing priorities. The loss of the medical/scientific expertise and involvement by those most heavily invested in bringing better treatments to patients is detrimental to the industry. Perhaps it’s time for an NIH initiative to remove the barriers to entice the academics back into sponsored research.
MARY ROSE KELLER
Mary Rose is VP of clinical operations at Heron Therapeutics. She has 30+ years of industry experience.