
Competing studies and therapeutic area saturation: when your portfolio outgrows your patients
Analyze the competitive study landscape at the site level, assess therapeutic area saturation, and apply a structured accept/defer/decline framework when studies compete for the same resources and patients.
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The site has just been awarded a Phase III nonalcoholic steatohepatitis (NASH) trial. The protocol is complex -- liver biopsies, quarterly MRI-PDFF imaging, a 72-week treatment period -- but the investigator is excited and the patient pool looks adequate. Enrollment is expected to begin in two months. Then, within a single week, two more NASH study opportunities arrive from competing sponsors. Different molecules, similar mechanisms of action, nearly identical eligibility criteria, and overlapping enrollment timelines.