Neither physicians nor other investigative site personnel are trained in process development and verification – skills that are evermore necessary as study protocols become more complex and seek to identify treatment effects that are more subtle or difficult to distinguish within already medicated patient populations. Because of this, disruptions that occur to patient progress in screening, enrollment and completion of study procedures present barriers at a busy clinical site that cannot be easily overcome.
This critical deficiency can affect any aspect of the study process and underlies poor site performance that is widely recognized in the clinical research enterprise. As a result, site experience with treatment of as few as two subjects for a study protocol is accepted as a “good enough” review of the clinical performance of the investigational therapy or device. At this critical stage when the response in humans is obtained, informative observations that emerge, even from therapies that don’t hit their performance mark, are missed by those at the patient interface. When only two subjects are treated, a critical patient response in one may be dismissed as a random event and thus place all study patients at greater safety risk. A therapy that has cost a sponsor many millions in development may be abandoned when in reality, a thorough review of the event by trained individuals at the site might identify alternative opportunities for the investigational product. Thus, the SSRO Adaptive Investigative Site Management approach can greatly benefit patients, sites and sponsors.
While it may seem that sponsors would naturally position themselves to capture this detailed human clinical experience for each compound they have backed with significant research dollars, that capture is specifically prevented in the current approach. Hands-on review of detailed patient information and protocol process completion at investigative sites is outside the purview of sponsor and traditional CRO personnel because of the need to avoid conflict of interest issues. If sites had the time and trained personnel dedicated to detailed review of each subject in the study and the operational support to enroll a sizeable cohort of subjects, these items would be addressed routinely. The use of a site-aligned team of clinical research and process control subject matter experts to provide real-time review and adaptive solution design for the research study is the clear solution to this problem.
Adaptive Investigative Site Management has shown the ability to prevent these problems and/or address them rapidly as they occur. With the advent of adaptive clinical trial design, which requires interim data on study results to guide the adjustment of key protocol parameters, the need for clean data promptly provided from rapidly enrolling study sites is even more critical. Adaptive Investigative Site Management provides the personnel, expertise and oversight to provide this information while keeping patient safety at the forefront of site processes. This is why CTMG has worked for over eleven years to bring this SSRO approach to the clinical research world.