Inefficient and ineffective. That’s how John Neal, CEO of PCRS Network, sums up his frank assessment of the current state of the clinical research site selection process. In the third post of this four-part series, we explore the evolution of clinical research and its impact on the site selection process based on insights presented by Neal.
“Something on the order of 50% of all sites that are initiated across all studies don’t meet their original enrollment expectations,” Neal observes.
His research reveals that up to 11% of sites never enroll a single subject. The problem is in the process, and that process will change, Neal predicts. One aspect of that change will be that the selection of sites will begin with the identification of patients.
“Starting there and working backward is a huge paradigm shift,” he notes. “That change will drive increases in efficiency, and will minimize the number of nonperforming or underperforming sites.
“That will send tremors throughout the industry,” Neal adds. “Right now we have a lot of sites that are fighting for attention, fighting to get the next study. As the site selection process improves, some sites are going to lose that fight. As an industry, as we get better at identifying and selecting sites, instead of initiating 100 sites, 50 of which will underperform, you’re going to see maybe 30 sites that are initiated, all of which will meet performance expectations.”
As fewer sites are needed, some study procedures will be performed outside of the traditional site venue and site structure. Certain study visits may occur at the subject’s primary care physician’s office, or at a specialist’s office, Neal predicts.
“That has major implications and ramifications for staffing and for site selection,” Neal says. “When proximity to the initiated site’s location no longer limits the selection of study subjects, you now open up the opportunity for a site to have volunteers enrolled that may be on the other side of the continent.”
Out goes inefficiency, in comes the future. Are you ready?
In our last post of the series, Neal takes a look at single dose studies and the opportunity for collaboration between multiple sponsors.
ICYMI (In case you missed it)!
The first post in this four-part series: The Future of Clinical Research Technology: Introduction.
The second post in this four-part series: The Future of Clinical Research Technology: Data Collection.