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Risk-reward tolerance standing in way of underperforming trials for sponsors.
Sponsors are losing ground to study sites: “We will deprioritize your study.” Sponsors expend a tremendous amount of resources identifying and initiating new sites for their studies; however, these investments are wasted when a study site deliberately diverts study resources away from studies that are operational failures—or, in essence, when the site quietly quits your trial.
"There is too much risk to prescreen subjects compared to the amount we receive after they enroll," "the protocol is too strict," and "patients aren't enrolling because their stipend is too low" are common reasons why sites deprioritize studies. In this article, I will share my experience and provide recommendations.
After site initiation, study deprioritization occurs when a site deliberately diverts resources away from your trial. The typical cycle begins with the hope that the clinical trial will enroll patients; once initiated, the site attempts to enroll patients but fails (for a variety of reasons), then realizes that the recruitment effort was not worth the risk, and they refocus their resources on studies that are more likely to enroll patients.
Common causes of deprioritization of clinical trials include the following:
Deprioritization of your trial is the worst possible outcome. Not only do you waste capital and resources on initiating the site, but you also miss your target enrollment numbers due to missed expectations and, as a result, delayed study completion timelines, continue to spend capital maintaining the site with regular monitoring visits, and pay closeout visits and fees—all of which result in a negative return on investment.
The deprioritization of clinical trials seems to be primarily related to risk-reward tolerance, and study sites are adept at measuring this tolerance, leaving sponsors with underperforming trials. Despite this, sponsors ignore the realities of complex protocol design, poor protocol optimization, substandard recruitment and prescreening support, and limited study budgets. By addressing these issues, sponsors could prevent sites from deprioritizing their trials.