The conduct of a clinical trial involves many players: the sponsor’s project team, investigators, lab technicians, field monitors, data managers, biostatisticians, medical writers, and others. The extent to which these participants follow the study protocol in fulfilling their responsibilities will determine the overall success of the trial. In the past, some sponsors felt more in control of their study’s outcome if most of the trial participants were company employees (except for investigators, who must be independent).
Today, a growing number of sponsors are outsourcing many study roles to third-party providers. The outsourcing of one role, however, still remains controversial: field monitor.
Theoretically, whether the monitor is a sponsor employee or an independent agent shouldn’t matter. In fact, whether an independent monitor performs their duties on a full-time or part-time basis shouldn’t matter either. After all, virtually all investigators are full-time veterinarians who fulfill their study responsibilities part-time. What matters in each case is the quality of the work, not whether that work is the individual’s sole occupation.
VICH GL9, Section 5.1, says: “The monitor should have scientific training and experience to knowledgeably oversee a particular study. The monitor should be trained in quality control techniques and data verification procedures.” A properly-trained part-time independent monitor could satisfy these requirements just as well as a well-trained full-time sponsor-employed monitor.
To demonstrate this point, I’d like to tell you a story.
Martin* began his career 20 years ago, as office manager for a veterinary practice, while completing his degree in animal science. The clinic’s owner noted Martin’s attention to detail, and asked him to coordinate a clinical trial being run at the clinic. In the beginning, Martin viewed study activities as exciting, cutting-edge veterinary medicine. However, as the clinic took on more trials, these activities consumed more of his day, and Martin found that he had to work nights and weekends to keep up. Finally, he decided to make a change.
Martin enjoyed study work more than practice management. So, he left the clinic, took a series of courses, passed the certification exam, and became a full-time monitor. Soon, he was working with major pharmaceutical companies, monitoring multiple clinics, and learning about promising new therapies. He traveled to new places, and made a lot more money. Along the way, he met and married the woman of his dreams. Life was grand!
Over time, the excitement waned. Martin began traveling so often that he missed his children’s birthday parties and school functions. Budget constraints led sponsors to lower his rates and travel allowances. As well as he planned his monitoring visits, he often arrived to “Sorry, it was an emergency. Can you come back tomorrow?” Travel delays became so frequent that his productivity and income suffered. The final straw was a failed rental car water pump that left both him and the car steaming, fifty miles from the nearest town. Waiting for the tow truck, Martin decided to make another job change.
Back home, Martin took some vacation. He searched for practice manager positions within short commutes of his home. The clinic he finally joined has three veterinarians, all interested in clinical research but as yet not involved. Soon, Martin was coordinating an exciting trial at his new practice. Later, he found other clinics in the same situation. Now, he manages his practice where he coordinates one or two studies a year. On his days off, he works for a contract research organization (CRO) as a part-time monitor on other studies. With his top-quality results, Martin is in high demand. He could work full-time for the CRO or join a sponsor team. But Martin likes the variety of his current position. He also sleeps in his own bed every night, hasn’t missed a single one of his children’s important events and, last year, earned more than he ever made as a full-time monitor. Life is grand again!
The morals of this story? First, not every monitor works full-time. In today’s complex world, people strive for balance between their work and personal lives. Without balance, work and personal lives suffer. Second, happy, unstressed monitors are more likely to produce good results on time than over-booked travel-weary ones. Third, those happy, unstressed monitors often live not too far from study sites. If you find them, be they full- or part-time, your sites will get closer support and you will get better results.
* “Martin” asked that his real name not be used.