This post is Part 3 in a series based on the Complion webinar, The Future of the Clinical Research Industry, as presented by John Neal, CEO of PCRS Network. In that webinar, John explores a variety of factors that are driving the evolution of clinical research.
Inefficient and ineffective. That’s how John Neal sums up his frank assessment of the current state of the clinical research site selection process. John bases that assessment on data available from CenterWatch and other sources. “Something on the order of 50% of all sites that are initiated across all studies don’t meet their original enrollment expectations,” John observes.
John’s research reveals that up to 11% of sites never enroll a single subject. “That’s crazy,” he says. The problem is in the process, and that process will change, John 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.” That change will drive increases in efficiency, and will “minimize the number of nonperforming or underperforming sites.”
That will send tremors throughout the industry. “Right now we have a lot of sites that are fighting for attention, fighting to get the next study,” John says. 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,” John says. Certain study visits may occur at the subject’s primary care physician’s office, or at a specialist’s office.
“That has major implications and ramifications for staffing and for site selection,” John 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,” John explains.
Out goes inefficiency, in comes the future. Are you ready?
Access the full on-demand webcast, “Predictions: The Future of Clinical Research,” featuring John Neal, CEO of PCRS Network.