Clinical trials are complex and costly. With 2010 estimates of average total expenditures for a pivotal clinical trial in excess of $40 million for a PMA product and nearly $11 million for a 510(k) product, sponsors understand the value of executing an efficient, high quality trial.
The best people in the right roles
One way of adding efficiency to a clinical trial and improving the likelihood of meeting milestones is to have the best people in the right roles. Getting the right people to do what they do best allows for streamlined and high quality task completion. This efficiency can lead to a reduction in errors, do-overs, and audit findings. We present an example of this fundamental by examining the skillsets needed by a Clinical Monitor versus a Clinical Proctor.
What is the difference between monitoring and proctoring in a clinical study?
The Cambridge Free English Dictionary defines a monitor as someone who carefully watches or checks particular things over a period of time and defines a proctor as someone who watches people taking a test to answer questions and to insure they don’t cheat. In both cases, the individual doing the watching is tasked with ensuring consistency, quality and compliance of some process to a set of procedures or rules. These definitions take on slightly different meanings when used in the context of clinical trial operations.
In the world of clinical trials, the term monitor is used very similarly to its dictionary definition, where the Clinical Monitor is tasked with watching and confirming accuracy, quality, consistency of clinical trial data, as well as ensuring compliance with regulatory guidelines. This is essentially an auditing role that requires excellent attention to detail, knowledge of clinical trial regulations, and a working understanding of medical terminology and clinical pathology.
The term proctor, however, has a slightly different connotation than the dictionary definition, with the focus primarily on training. For a clinical trial, the individuals in a Clinical Proctor role are required to train medical personnel, often cardiologists or surgeons, to use a new medical device according to the manufacturer’s instructions and the regulatory agency’s restrictions. Many of these innovative devices are complex and highly technical, and require expertise in deploying them safely and effectively. Therefore, a Clinical Proctor must have the same skillset as a Clinical Monitor, but must also be proficient and comfortable in the procedure settings, like catheterization labs or surgical suites, where a device is used. They must be experts in existing procedures used to treat the conditions in question AND in those for the new device. They must be comfortable and confident in instructing very highly trained physicians on new procedures and in ensuring that the physicians have mastered any subtleties of the new device.
Why it matters
Sponsors will often hire separate staff as Clinical Monitors and Clinical Proctors, and that can sometimes work quite well. However, when outsourcing clinical trial operations, there is an unquestionable advantage to hiring individuals with both monitoring AND proctoring skills in their toolboxes. Efficiencies in communication and knowledge of particular case histories can be attained along with the economic efficiencies associated with one staff member fulfilling two roles.