Investigative site logistics and core business models vary dramatically.
The commonality is that they all have defined parameters, or constraints, they must work within. Sometimes these constraints—physical, financial or involving personnel—are inflexible. What defines a successful site is a true understanding of set parameters and the ability to evolve and expand within them.
Consider the single physician/investigator practice. Usually, one investigator, one study coordinator and one part-time administrator participate in several trials simultaneously. The research and practice treatment areas share a small space, which can be challenging. The lab area, study records area, study coordinator work space and drug storage are located within close proximity, so the study coordinator can complete critical tests or prepare and dispense the investigational product with specific temperature restrictions in the most efficient manner.
Alternatively, large academic institutions often have patient treatment areas, administrative offices and pharmacy spread across several blocks that comprise a large campus. Experienced research staff know to add an extra time buffer when conducting research meetings or monitoring visits to accommodate the distance and complete the required tasks at each separate location on campus. Research staff also have developed an effective communication process with key staff at each location to ensure consistency and accuracy when completing study procedures subject to time or utilization restrictions.
Regardless of size or location, research staff must be aware of their site orientation and process flow to ensure trial success.
The many site business models include single investigator physician practices, large academic institutions with numerous investigators, dedicated research organizations with physician owners or employees, dedicated research sites that contract with physicians on trials and site management organizations with large research networks. The list is endless and ever evolving.
I often am asked what the best site model is for a physician eager to conduct clinical trials.
Physicians should serve as Sub Investigators to gain clinical trials experience. Under the tutelage of an experienced Principal Investigator (PI), they will be trained on best research practice, investigator oversight and commitment and human subject protection. This is an ideal training ground for new PIs and usually results in them slowly taking over PI responsibilities and, eventually, their own trials.
For independent physicians working as part-time Sub I’s at other locations, the next natural step is for them to assume responsibility of their own trials at their own facilities. This is more difficult for single physician practices.
So, what is the best site business model for a new investigator to adopt?
This question unexpectedly was answered by an experienced research organization with a wonderfully transparent site status policy.
I was assessing sites for a newly awarded renal study. The protocol tests were standard; it was an ideal design for a new PI, simple and straightforward. However, I had not encountered a new PI until this visit.
The site manager provided a thorough explanation of the site business model and overall investigator status. The PI was an internal medicine physician in private practice. He had partnered with an experienced research organization as a PI on clinical trials. The organization provided research staff and he provided the work area within his practice. This logistical set up assured close communication between the PI and the study coordinator, as well as an established infrastructure within the practice. It was a fairly common model.
The site manager said the PI was new to working with the research organization. I asked if he was new to clinical research. The site manager was surprisingly candid, saying the PI had served as a Sub Investigator on two studies and recently had been selected to serve as PI on a study in startup. The site manager sensed my hesitation with the PI’s inexperience. However, thanks to his candor, we had a positive and focused exchange regarding his training and assimilation to the PI role.
With a satisfactory training plan and site model established, I felt comfortable selecting the site for the study. The staff understood the benefits and constraints of their situation and developed a successful research plan that leveraged logistical benefits and made efficiency of constraints.
E lizabeth Blair Weeks-Rowe, LVN, CCRA, has spent nearly 14 years in a variety of clinical research roles including CRA, CRA trainer, CRA manager and business development director. She has written and edited newsletters for several CROs, created training curriculum for CRA/clinical research educational and training programs and is a contributing writer to several research publications. She currently works in relationship development/study startup in the CRO industry.
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