Physician’s Perspective on Simplifying Clinical Trials
​​[Posted on: Thursday, November 2, 2017]

Physicians are increasing frustrated with the increasing complexity of clinical trials, in their opinion, and the seeming duplication of work that could be avoided by better use of available technology. A commentary published in MedScape by Dr. John Marshall of the Lombardi Comprehensive Cancer Center at the Georgetown University Hospital highlights several common clinical trial practices found unnecessary and annoying by physician investigators. Most of these are fair complaints that need to be addressed by sponsors of clinical trials. About half of the physicians participating in clinical trials do only one trial. Short supply of experienced investigators leads to increased cost of training new physicians for each clinical trial and a big disconnect between patients that could potentially benefit by participating in clinical trials, and their physicians who want to offer such trials. Experts have worried about this “one-and-done” problem and tried to find ways to address it. However, Dr. Marshall points out to some common complaints that have not been the focus of most solutions offered. First, most clinical trial training for physicians could get repetitious and unproductive. Practically every sponsor wants to initiate a given clinical trial by doing a comprehensive training not only in the planned clinical trial protocol but also basic GCP, adverse event reporting, data collection practices and other common clinical trial tasks. Common complaint from physicians is the repetitiousness of this information. Ideally, clinical trial training should be standardized to avoid repeated training in common clinical trial tasks. The more experienced an investigator, the less training he/she needs. Training should be risk-based to address specific errors, rather than in everything. Second, many of the common data elements captured in clinical trials are also collected on the patients’ electronic medical records. Due to technical, business and regulatory challenges, most sponsors end-up re-collecting the same information on the source documents for the clinical trials. Doctors want that information entered in one place be transferred to all other places needed without them being asked to re-enter. This would reduce the time for data collection and spare time for patient care. Third, Dr. Marshall contends that clinical trial endpoints could be simplified to more clinically relevant outcomes that can be possibly captured easily. This is a harder change as clinical endpoints need to be validated and accepted by FDA before they can be used in clinical trials. Most sponsors prefer using well-established clinical trial endpoints rather that creating new ones which would add extra work and risk. Fourth, Dr. Marshall points out to the high cost of trial management mostly due to outsourced components. Again, from the sponsor’s perspective, there are few options to outsourcing trial management. Sponsors need to listen to physicians and address complaints for better trial conduct and reduce the “one-and-done” issue.