Report spotlights cost constraints in clinical study activation—and the search for efficiencies

Advarra, a regulatory review solutions and clinical site technology provider, has published a report called The State of Clinical Trial Activation at Sites, which outlines actions to help simplify and streamline clinical study activation and maximize operational efficiency. The report is based on a survey the company conducted in late 2020.

Industry data suggest that it can take over 180 days to activate a clinical research study and the process continues to get longer, Advarra cites. The longer it takes for a new therapy to reach the market, the more time and resources research sites use, and these delays can possibly impact their chances of being selected for future trials. Pharma sponsors are also trying to figure out new ways to bring drugs to patients sooner rather than later.

In its report, Advarra surveyed clinical research professionals from academic and commercial sites. They examined the industry’s current practices around study activation and identified the key processes it impacts, along with associated resource constraints. Highlights of the findings include:

• 35% of survey respondents reported activation timelines of 91 days or more.
• Only 19% indicated their study activation process is completed in 30 days or less.
• Investigative sites (such as independent, private practice and dedicated research sites) were more likely to report shorter activation timelines (80% reported 60 days or fewer) than hospital/health system-based sites (34%) or AMCs and universities (21%).
• Almost two thirds of respondents (63%) indicated that negotiating fees were a reason that budget negotiations took a long time.
• Of those who indicated fee negotiation slowed budget negotiations, 83% indicated that negotiating startup fees was a specific reason that budget negotiations took a long time.
• About 85% of respondents recovered costs associated with scheduling and facilitating monitoring visits (86% and 84%, respectively).

The report points to five key success factors affecting study activation and offers solutions to sites wanting to improve their study activation process. While activation timelines have continued to lengthen, hindering protocol startup goals, there are tactics sites can implement that will help make protocol activation more efficient, Advarra finds.