Engaging Emerging Clinical Investigators Yields Unique Benefits for All

Benjamin Marcum, MD, family practitioner, Stephenville Medical and Surgical Clinic, Privia Health

Emerging investigators play a vital role in bringing new patient populations to clinical trials, but reservations around their ability to deliver persist. Recruitment and retention continue to pose a hurdle to clinical research resulting in increasing recruitment of practicing physicians outside of academic centers, and for good reason.¹

Investigators with a rural practice, such as mine in Stephenville, TX, add more geographic variability to the predominantly urban and suburban landscape of clinical trials. As community physicians, we are often also able to reach more ethnically and racially diverse participants, due to close personal ties with patients in these areas.

Such recruitment benefits impart a compelling endorsement of emerging investigators. However, several additional advantages of engaging these investigators in clinical trials are less frequently discussed.

Strong familiarity with patients and communities

When physician investigators such as myself are embedded within a community practice, we have intimate knowledge about the patient populations served. As a result, we provide valuable (and otherwise unobtainable) input for many aspects of study design. This begins with recruitment. For example, we can predict which trial designs will be palatable for our patients. We also have insight into factors that will aid in participant retention, such as a clearer understanding of which trials and protocol iterations will be more attractive to our patient population. Many times, I have provided feedback to sponsors about protocol design that could be off-putting to the targeted patient population and the sponsors listen.I see many subjects in the research clinic and my personal clinic, which improves communication, compliance with e-diaries due to reminders of the importance of data collection, and enthusiasm for continuing with clinical research. Research is only a small facet of my relationship with most of our subjects and thus, they trust the research center and fewer barriers impeded retention and compliance.

Patient care backed by personal connection

Our concern for the health of our patients leads us to genuinely and enthusiastically encourage them to participate in trials that we think will help them. I have practiced in my community for ten years, and I plan on practicing for many more. Beyond my professional obligation, I have relationships with people within the community who go on to become trial participants—I see them at the grocery store, at football games, and in church.

My greatest source of pride as an emerging investigator is being able to provide newer treatment options and medical care to those who would not otherwise have access. Additionally, through the trial screening process, we have the potential to unearth other health conditions that were previously unnoticed. A few months ago, at a screening visit we noted some EKG changes in a patient with cardiovascular disease, and referred them to a cardiologist, where they received catheterization and stents before having a cardiovascular event. We have also screened for cervical cancer and sexually transmitted diseases as part of a birth control study and identified disease in women who were not previously aware of their health status—and did not have access to cervical cancer screening otherwise.

Providing these services to our patients through an integrated approach to trial delivery is extremely motivating for us as investigators. Because clinical research is established within our healthcare practices, trial participation is accessible as part of our overall offerings. This provides added value to our patients, while also providing momentum supporting clinical research advancement as a whole.

Curiosity and a collaborative spirit

Emerging investigators often ask a lot of questions at the outset of a trial, reaching out to colleagues, trial support staff and even leadership from our sponsor or vendor partners. We must seek out best practices as we gather knowledge about the trial landscape. This leads to valuable interaction and collaboration. Fresh eyes on a protocol can only augment the sponsors’ offerings through the application of clinic curiosity.

There is no doubt that new investigators need support as they enter their first trials. Sponsors might hesitate to include new clinic-based investigators due to fear of compromised data, laxity concerning GCP procedures, difficulty managing investigational product, and so on. In my very real-world experience, with the proper partnerships, infrastructure, processes and plans, getting started really can be relatively frictionless. The clinical investigator’s initial curiosity and collaborative spirit surmount these barriers and allow the embedded clinical research center to truly thrive, despite industry’s initial hesitations concerning their lack of experience.

In the beginning, my greatest challenge in Stephenville was to train staff. This did take some time, but it was made possible through collaboration with our clinical research partner, Javara, an integrated research organization (IRO). They are contracted by my medical group, Privia Health. With Javara’s support, combined with online training resources, we rapidly gained the knowledge and skills necessary to launch clinical trials from our practice.

This partnership has continued and is central to how we conduct all our clinical trials. In addition to serving as an investigator, I am also the medical director of clinical research for Privia Health in North Texas and meet with Javara leadership once or twice a month. This is a chance to offer feedback on our successes as well as any challenges we are experiencing. Close collaboration of this nature really allows emerging investigators to stay curious and to bring a fresh perspective to the conversation. With the right support, we can contribute to clinical research as efficiently as those more experienced in the field.

Without the help of a knowledgeable IRO or CRO partner, I would not have been able to manage clinical research independently. They oversee staff, provide necessary equipment and guide our team through regulatory documents and processes. This support also helps allay any compliance risks that can emerge, given the level of scrutiny faced by clinical trials.

A fresh approach and enthusiastic mindset

As we emerging investigators embark upon our journey into clinical research, we are not tied to certain processes or procedures. There is no obligation to maintain the status quo, and we are less apt to accept the “it’s the way it’s always been done” mentality. I believe our open-mindedness provides all stakeholders a unique opportunity to explore newer methods and systems during mentorship and training as well as throughout a clinical trial. The landscape of new digital tools and platforms, including artificial intelligence applications, is continually changing. Those of us newer to research often tend to be more open to embracing such tools because our instruction does not require any unlearning and thus saves time, energy, and potentially resources.

New clinic-based investigators are enthusiastic. We are accustomed to long hours and the intricacies of clinical practice and clinical research offers the emerging investigator a new and exhilarant flavor to our daily work. I have been thrilled with my journey into the world of clinical research, as it gives me an opportunity to learn about new medications and treatment regimens as they are being developed. This has helped to keep me on the cutting edge of advancements in medical science, and I have been able to keep my patients informed about what is on the horizon.

Clinical practitioners can sometimes fall into the habit of treating the same old maladies with the same old therapies—that may or may not exhibit the efficacy desired. Every day it seems, there is a new opportunity in my inbox, and I relish reading about the novel mechanisms of action and therapeutic targets I get to participate in bringing to those that need them most. This translates into an enthusiasm for the work that drives my desire to engage subjects and keep them engaged. Ultimately, I believe the spirit of clinical investigators positively affects the clinical trial ecosystem. Our patients sense our enthusiasm for their care, and I have seen this spirit invigorate other research staff at investigator meetings as well.

Conclusion

Overlooking the advantages of engaging emerging investigators in clinical trials negates the influential role they play in the sustainability and evolution of clinical research. I believe that as new investigators, we not only boost research capacity and expand access to geographically, racially, and ethnically diverse patients but also hold the power to help integrate research into communities more effectively. The fact that we are newer to the clinical trial ecosystem may mean that we bring in less hands-on trial experience, but we bring new perspectives, open-mindedness, and enthusiasm. As we collaborate with more established members of clinical trial teams and learn from them, we add new dimensions and carry knowledge forward for the ultimate benefit of all involved. We are a rich resource ready and waiting to engage sponsors in the real world where medicine happens—I can’t wait to see where we go from here.

Benjamin Marcum, MD, is a family practitioner at Stephenville Medical and Surgical Clinic, a part of Privia Health, in Stephenville, TX.

Reference

1. Miessler, J. With high investigator dropout rates in trials, sites and sponsors must offer more support. CenterWatch. https://www.centerwatch.com/articles/25706-with-high-investigator-dropout-rates-in-trials-sites-and-sponsors-must-offer-more-support. Published June 6, 2023. Accessed July 9, 2024.