This is the third installment in a series on changes coming to the clinical research enterprise from John Neal, CPA, BS, CRSP, founder and CEO of PCRS Network, LLC, and member of the ACRP Board of Trustees.
Prediction 3: My third prediction is made up of two parts, which are: the process by which sites are selected to conduct studies will be radically transformed, and fewer sites will be needed in the future
Based on my research, there is compelling evidence pointing to the movement toward replacing the existing site selection process with one that begins with identifying individual patients that will qualify for a study. After those patients are identified and geographic concentrations are determined, networks of sites that provide coverage for the areas of concentration, and which can deliver additional efficiencies by centralizing many of the non-clinical functions required to conduct studies, will be selected. Individual sites not affiliated with a network affording those benefits to the sponsor will only be selected if they have access to high concentrations of the target study population.
If you look at how I/E has continued to expand to specify much more individualistic or personal criteria, it is going to be harder for individual sites to find study subjects within their normal coverage domain. It is going to require much more collaboration to find patients that qualify for studies.
You may ask why such a radical transformation is needed. The answer lies in the fact that the system of site selection commonly used in the industry today is simply broken.