Becoming A PI: The Power of Physician-To-Physician Recruitment

By Katie Smentek, MD, Mankato Clinic

Embedding clinical trials in healthcare facilities gives patients access to cutting-edge treatments and technologies. In our case, at the Mankato Clinic in Mankato, MN, patients would otherwise have to drive an hour and a half to access such advances. Clinical trials also allow us to care for patients who have no insurance or are underinsured. It's not only valuable for these patients to be connected to the right clinical trial, but it’s also satisfying for physicians to provide this care.

The Mankato Clinic is a physician-owned, independent multi-specialty group. We have 81 practicing physicians, and we are always looking for new opportunities to expand our reach. When our integrated research organization (IRO) approached our executive team and explained the support they provide by embedding staff and infrastructure into large healthcare organizations, the executive team was intrigued and issued a call to gauge physician interest in conducting clinical research.

Becoming My Group’s First Clinical Research Principal Investigator

I serve in leadership positions in our clinic, and when I first heard about the opportunity to participate in clinical trials, I was excited and curious to know more. Having completed my residency at Yale-New Haven Children's Hospital, where there was an expectation for physicians to continue in research, I had found it challenging to abandon this aspect of my training when returning to my small hometown. As a part-time pediatrician, I felt that I had the flexibility in my schedule to lead the charge in becoming the first investigator for our clinic. I was nervous to take on a new endeavor but deciding to serve as a principal investigator (PI) and integrating research into my practice has been immensely fulfilling.

As the first PI of our group, I have become a mentor and spokeswoman for the program. It is extremely valuable to have physicians recruit other physicians, and this role is part of a natural process and evolution. There is a trust, and doctors know that I am aware of what it means to fit more activities into a hectic workday.

I work with a fantastic group of physicians who have specifically chosen to work in a bustling outpatient community clinic. Research was not in their long-term career plan, and there is some hesitation about adding clinical trials to an already heavy workload. I hear feedback that many can’t add one more thing to their plate. For those who have time and interest, however, I can provide specific information on what this commitment entails. By sharing my firsthand experiences and observations from working through the various components of a research trial, I help my colleagues gain a better understanding of what it entails to be a PI.

I also find opportunities to communicate with other physicians to make them aware of my research, so that they can refer eligible patients. I publicize the trials at our quarterly group meetings and in our newsletter. It’s a natural addition to speak about the benefits of being involved in trials as an investigator.

The relationship that physicians have with clinical trials has an impact on how the community sees the research. Mankato is a small community, so we need to be very thoughtful. The Mankato Clinic has spent the last 100 years in our community asserting our commitment to patient safety. Patients need to feel confident that any activity we pursue is in their best interest. It is our job as researchers to ensure that our community knows we are participating in research trials that we feel are safe and will provide benefit to this community, both at the time of the research and in the future. The more physicians that are informed and involved, and who can genuinely present the trials as a way for the patients to access cutting-edge opportunities, the more acceptance there will be within the community.

Educating My Peers On Leading Clinical Research

When I speak to physicians with recruitment in mind, I point out that we all have experience with science and are really scientists at heart. We also rely on the work researchers have done in the past. Every decision I make is based on someone else’s research, and the research we do now is going to affect what we do tomorrow, or next year, or in five years.

The largest physician concern is the time demand. I explain how it is possible and manageable to fit research into their schedule alongside their patient load, and I describe the support they would receive from our integrated research partner, Javara. A member of the support staff sits across from me and advises if I need to review an adverse event, or if I need to answer a patient’s question. Ahead of a participant visit, the support staff member explains exactly what the visit will entail and suggests verbiage to provide the patient, and afterward they type up the notes. Having a support team embedded in the clinic makes an enormous difference.

Because of time constraints, allowing investigators to set their own schedules is crucial. I emphasize to potential physician recruits that our research partners can tailor the arrangements to their needs. While I can comfortably accommodate trial participants between my regularly scheduled patients, some physicians may have schedules that do not allow this or do not like to shift gears quickly. In such cases, they may reserve an hour after finishing with regular patients, come in on their half day, or work through their lunch to see trial participants.

Providing clinical research as a care option is not only convenient for investigators and patients but also for sponsors. Having a person on-site at the clinic who can review records and communicate with primary physicians simplifies the recruitment process significantly. The collaboration and partnerships we have established not only bolster our investigators but also streamline the process for all involved, resulting in a sustainable approach.

Onboarding New PIs With A Careful Approach

I have found that the most effective PI recruitment technique is to give physicians who are on the fence the opportunity to become sub-investigators. This allows them to see what is involved and gain experience without immediately carrying the full responsibility of a trial. Once they see that this process is not as labor intensive as their research experience in college or medical school, they are more likely to be receptive when someone offers them the opportunity to be a lead PI. Approximately 10 additional physicians in our group have expressed interest and are completing training to become clinical trial investigators. They will begin as sub-investigators, and we expect many to become PIs.

When speaking to physicians, it’s vital to be clear about expectations. Investigators need to do online training, be confident with the details of each study, and be flexible during their workday. There are several requirements at the beginning of a study that I did not fully understand until I was immersed in the process, ranging from the number of training sessions to new apps and passwords to remember. Completing certain trainings in a study can also open the door to other roles such as lab director. The research team was always readily available to help me every step of the way, but I have found that the best path for learning is simply to dive in and gain firsthand experience.

My experience with recruitment has shown that once a physician’s interest has been piqued, a considerable amount of persistence and perseverance may be necessary to guide them through the requisite procedures to get started. As in all other stages of the process, the more support that can be provided, the higher the chances of success.

Sponsor And Vendor Support Makes The Difference

It is important that healthcare institutions and sponsors make it as easy as possible for physicians to become clinical trial investigators. Physicians are busy, and time commitment is their primary concern. Embedded partnerships increase convenience for physician investigators and optimize outcomes for sponsors and patients. Sponsors also can support investigators by making the study onboarding process and requirements as clear as possible. Physician-to-physician recruitment is powerful, because it leverages trust and mentorship within an organization. It just takes one physician to dive in and then report back to other physicians about how rewarding the experience can be — for the patients and the PIs.

About The Author:

Katie Smentek, MD, FAAP, is a pediatrician at the Mankato Clinic in Mankato, MN. She began clinical research one year ago and currently has two active studies ­— ­­an asthma medication trial and an infant vaccine trial. To date, she has recruited five sub-investigators to assist.