In my ongoing saga series on clinical research, I thought I’d share my thoughts on the advantages and disadvantages of requiring regional medical monitors be located in specific countries.
One of the points raised during the planning stages of a clinical trial is often the geographic location of the team members. The Clinical team in particular pretty much has to be based locally because they will be performing site visits and interacting very closely with the staff and investigators, but it’s not unusual for other team members to be based around the globe. Data management team members for example are frequently located in Asia due to a large population of skilled talent available at more economic salaries than if they were based in Western Europe or the USA, and the fact that their work can readily be performed remotely and asynchronously with the rest of the project. But what about the Medical team?
The Medical Monitors are typically physicians with at least some experience in clinical practice (although the actual time people have spent varies considerably), and many have some degree of subspecialty training. The interesting thing is that a very large part of the job is subspeciality agnostic – the safety data we review all looks the same, and it’s largely a case of lining up the findings with the study-specific protocol to weed out the more detailed anomalies. Whether the study drug is being given for one thing or another is largely a moot point. When looking at things like protocol design and study planning and execution, there is absolutely an element of subspeciality knowledge required, but it isn’t that unusual for a physician trained in one area to find themselves working on a clinical trial in another. Furthermore, clinical trials are often global in nature and may have sites not just in different time-zones, but on different continents, and the Medical Monitoring work itself is readily performed remotely. For this and other reasons, the physical location of the Medical Monitor may not be considered relevant, but I would argue that there are very good reasons to keep the Medical team regional and optimized for the study, beyond the simple consideration of time-zones.
In the early planning stages, similar to being a subject matter expert from the disease/treatment perspective, it can be critical to have the insight of a local physician when considering things like screening failure rates, ease of enrollment, site and investigator selection, and even country-specific nuances on treatment guidelines or standards of care. For example, if a protocol requires that a specific comparator drug be used, but that drug isn’t approved or recommended in some countries, then it would be a mistake to try to conduct the study in those countries. Certain medical conditions are more or less common around the world, whether due to genetic or environmental factors, and these can dramatically impact enrollment rates and timelines. While it is true that a lot of this information can be obtained and understood by any physician, I think it’s still prudent to consult someone with that knowledge from a medical perspective.
During one large project I was on, we received feedback that a particular medical test was likely under-budgeted, which might lead to sites refusing the take the study on if it were not reimbursed properly. It was something that was highly unusual in routine medical care, but which I happened to have knowledge of and an awareness of the complexity of the procedure. Having an awareness also of the way the American healthcare system tracked and billed for these tests, I was able to direct the budget analysts to the correct amount to cover which impacted not just the proposal I was currently working on, but any others that used the same test. Someone without that knowledge of how the system worked might not have even known that there was an answer out there to find, never mind find it.
One area that is also important, although it’s often not realized until it’s needed, is clear communication with the sites and Investigators. While it’s true that English is widely used and understood, and tends to be the “lingua franca” of the research world, it’s also true that English is a second language for most. It seems prudent, if not simply polite, to be able to converse with site staff and investigators in their native language, and furthermore to have the social cues and etiquette familiar to them. I can speak French fairly well, but I know I cannot communicate the nuances in French that I can in English. At best, this can slow down communication if a third-party is required on a phone call to interpret in real time – at worst, it can lead to miscommunication and inadvertent offense. I have found that the issues are compounded if a person who natively speaks one language converses in English with someone who natively speaks another, and because clarity and attention to detail are SO important, I think it does behoove us to consider this aspect of study execution when assigning Medical Monitors. I don’t think this necessarily requires physicians geographically local to the sites, but doing so definitely decreases the odds of miscommunication.
Having already said that geographic location is irrelevant when considering the basic data and safety review tasks (with the exception of nuances in country/region specific regulatory reporting of urgent cases), there is other reasons for appointing Medical Monitors in alternative locations to the main study sites, especially if the time-zones at least line up. For one, it may be economically advantageous to hire on physicians from certain countries, or the volume of work may simply require multiple people with the team members scattered. There is also the very real possibility that the most experienced or suitable physician for that study isn’t local, or the sponsor may have a specific preference based on past experience with that person, so obviously a number of factors need to be considered.
Importantly, because the needs are different for project development versus execution, It may be the case that the subject-matter expert assigned to the initial proposal team isn’t assigned as the Medical Monitor. In that situation, it’s crucial for a comprehensive hand-off/kick-off meeting to occur to make sure that any issues or risks identified during the initial work are communicated over to the main team.
From the perspective of the sponsor, I would consider all of these issues when looking at the Medical Monitor assigned to your study – what aspects are most important to you, and what tasks are they most likely to be performing? I would say that if site communication and insights are important, then advocating for a local assignment would be a good idea. If you consider that subject-matter or clinical trial design expertise is more important, then you may want to be targeted in your selection regardless of geographic location. I am also a huge advocate for remote working for Medical Monitors, especially when considering all the factors above: there is a finite pool of experienced experts and if you happen to find someone with the right mix of clinical and research time, covering the right subject-matter, and with the personality and work-ethic to excel in clinical research, you absolutely should not limit your recruitment to physicians who are willing to relocate. Most physicians who are at the stage in their careers where a move to industry is feasible are in their middle years, settled with children and houses, and in many cases burned out with the time and demands of clinical care. Being told they have to uproot their family and commute through traffic to a desk job in an office is not appealing at all. I have seen several companies, both in the CRO world and in big Pharma (less so in Biotech interestingly enough), require their Medical Monitors to relocate and work on-site. I simply do not think there is a need for that in this line of work, especially in the post-pandemic era where work-from-home infrastructure is so well developed. If you’re requiring your talent to relocate you’re effectively giving the talent away to your competitors…
What’s been your experiences working as, or with, a regional medical monitor? I’d love to hear about the advantages and challenges you’ve experienced.
Nick Bennett MD 