Need An Investigator? There's An APP — Advanced Practice Provider — For That
A conversation with Katie Poplin, MS, associate director of clinical research, Clemson Rural Health
Among one of the emergent issues plaguing clinical research is the dearth of principal investigators. Some may attribute the paucity of PIs to first-time investigators forgoing a second trial after a poor experience, and others may say it’s due to disinterest or even a lack of awareness. What Clemson Rural Health (CRH) Associate Director of Clinical Research Katie Poplin, MS, sees is something more systemic, with roots in legislation.
As a rural clinical care and research provider, CRH knows well the challenges of finding and retaining physicians and PIs, and so it has relied instead on the work of advanced practice providers to deliver care and execute research.
In this Q&A, Poplin discusses the successful yet limited role APPs play in clinical research and how she hopes the legislative landscape might change to better incorporate them.
Clinical Leader: What roles are considered advanced practice providers (APPs)?
Katie Poplin, MS: Advanced practice providers are anyone who has received training and education beyond their initial medical degree. These roles include nurse practitioners and physician assistants. The extent to which an APP is allowed to practice medicine varies according to state laws. Typically, APPs can diagnose, treat, and manage chronic conditions. The state decides the level of care and amount of supervision required from a physician. For example, in South Carolina, APPs must have a collaborative physician with an established practice agreement that outlines the medical acts the APPs can conduct.
Though not typical investigators, APPs are capable of conducting clinical trials. What are some of the characteristics or skills that make them well-suited to serve as investigators?
Diversifying the investigator role has been discussed frequently to combat the PI shortage. In theory, involving more APPs in clinical research appears to be a great solution. APPs typically have more bandwidth since their primary role is clinical care and have less administrative duties. APPs are accustomed to collaborating with other providers and multidisciplinary teams and excel at following treatment protocols. Similar to physician investigators, APPs can cultivate long-term and trusted relationships with patients managing care over time.
An APP’s ability to serve as a PI varies by location (county, state, etc.) as well as institution (academia, for example). What challenges have you encountered so far?
The largest challenge I've faced is the medical world and the clinical research world acting as two separate specialties. There are few professional positions, such as PIs and legal counsel, that overlap both medical and research worlds, and when an individual holds knowledge of both, they are overworked and hard to find.
Clinical research and the medical industry are both heavily regulated, and for good reasons. However, state medical regulations leave a lot of gray areas when it comes to conducting research.
For example, cited in SC Labor Licensing Regulation (LLR) section 40-33-20 (5),… “an APRN may preform those activities considered to be the practice of a registered nursing or advanced practice consisting of nonmedical acts, such as population health management; quality improvement or research projects within a health care system; and analysis of data and corresponding system recommendations, revision, developments, or informatics. An APRN also may perform specified medical acts pursuant to a practice agreement…”. Cited in section 40-33-20 (45), “The practice agreement must establish the medical aspects of care to be provided by the NP,…”.
Who is the decision maker as to whether clinical research is a nonmedical act or medical aspect of care? Research is not synonymous with patient care; however, protocols often include standard of care activities that an NP would have to be authorized through a practice agreement to conduct that medical act. Furthermore, supervising physicians must be competent in the medical acts they are overseeing the APPs perform. Is prior clinical research experience required for supervising physicians to be competent to oversee an APP sub-investigator? These questions and gray areas rightfully cause APPs pause to participate in clinical trials, fearful of jeopardizing their licensing and ability to practice.
How have you attempted to address or resolve those challenges?
CRH is still striving to involve more APPs in clinical research and make their participation more efficient. Currently, a physician is still required to act as the PI for our clinical trials. Since we are an APP-led practice, we hired a part-time research physician principal investigator. This physician serves as our PI for all clinical research trials. APPs that serve as sub-investigators have updated their practice agreements with their supervising physicians that state they may participate in clinical trials and will be overseen for clinical trial activity by the principal investigator under an additional practice agreement. For each trial, an additional practice agreement is executed between the PI and APP sub-I to ensure all medicals aspects are appropriately supervised and documented.
There are several challenges and inefficiencies with this process. For one, supervising physicians in SC are limited to six supervisees. Requiring a PI to have a practice agreement for clinical research is limiting the number of sub-Is on a trial to a maximum of six. Additionally, this limits a physician who has other clinical responsibilities that require supervising APPs not involved in clinical research. Two, the documentation of practice agreements is overly burdensome. It is our clinic’s additional responsibility to store and manage more practice agreements per APP. Additionally, the clinical research documentation is duplicative for the PI supervising the study team, taking full accountability, as well as documenting training and delegation logs. And three, this process is not addressing the PI shortage and burnout. CRH’s research physician principal investigator had to have research experience and take on additional practice agreements. A physician is still required to conduct all study start-up activities and training.
CRH is aiming to comply with medical licensing requirements and research regulations, yet neither are straightforward nor encouraging APP engagement in clinical research.
How might sponsor companies, IRBs, or even regulators perceive sites with advanced providers as PIs? Are those perceptions justified?
In conversations I've held with sponsors, CROs, IRBs, and regulators, they are receptive to allowing APPs a larger role in clinical trials. Clinical trial stakeholders implement safeguards for investigators, such as providing and documenting training, requiring proof of education and experience, and understanding what protocol activities are appropriate for delegated personnel. However, clinical trial stakeholders do not have input on state laws or medical boards, and this is where true understanding lies for practicing permissions for clinicians. In the current climate, clinical research companies cannot open PI roles to APPs, because the medical regulations provide APPs the assurance they remain compliant with their practice permissions.
How do you hope to overcome those misperceptions and hesitancies?
CRH, though APP-led, relies heavily on our physician supervisors and specialists across the state. Ensuring physicians are accessible and specialized to mentor and advise APPs is vital. APPs’ relationships with physicians extend the physicians’ expertise and ability to care for more patients.
The rise of and trust in APPs is controversial among those in the medical field. These controversial views are demonstrated by the differing state laws. Some states have more lenient medical practice guidelines, such as allowing APPs to independently practice medicine, while other states have more restrictive practice guidelines, such as requiring a collaborative physician physically in the same location as the practicing APP.
The varying practice abilities and limits can cause hesitancy for APPs to practice to the full extent of their medical license. CRH has empowered APPs to care for patients within the bounds of their licensure, resulting in quality care to rural and underserved patients. Supporting physicians have also enjoyed working with APPs to help not only other medical professionals but also patients that are out of their physical reach. I think awareness of the APP role, understanding APPs collaboration with physicians, and clarity of research regulations with medical boards would empower and encourage more APPs to conduct clinical research.
And why is it important to advocate for APPs having a larger role in clinical research?
The root cause for the physician shortage is likely similar to the root cause for the PI shortage. There are simply not enough physicians to treat every patient, run our healthcare systems, and innovate with clinical research. CRH’s approach to the physician shortage in rural SC is staffing underserved communities with APPs. APPs can treat most patients and when needed consult with physicians on specific patient cases. This same practice could easily translate into clinical research.
Giving APPs a larger role in clinical research could open the doors for APPs to have more career growth, more medical professionals contributing to innovation, and more patients accessing clinical trials. Advocacy for APPs serving a larger role in clinical research takes out-of-the-box thinking and a multiprofessional approach. Medical boards and legislators must clarify grey areas involving research, sponsors have to understand APPs’ abilities and limitations, and APPs must be open and willing to take a larger role and responsibility with clinical trials. As a research administrator, my role is to highlight the possibilities, communicate the gaps and opportunities, and work with all professions to improve the quality and access to clinical research.
What does CRH, or sites like it, do to support the clinical research industry with APPs and the right patient population?
CRH is comprised of three physical clinic locations and mobile health units servicing the surrounding rural communities. CRH is also a nurse practitioner-led practice, meaning APPs are the sole providers at CRH and work closely with collaborating physicians and specialists across the state. This clinic and staffing model work because we are aiming to reach rural and underserved communities.
CRH is not only able to reach these typically neglected communities but is also able to provide compassionate care, health education, and various resources. These relationships, trust, and reputation are invaluable in underserved communities. There is great opportunity for the clinical research industry to tap into these care teams.
About The Expert:
Katie Poplin, MS, is the associate director of clinical research for Clemson Rural Health. Katie has over 10 years of clinical research experience. Katie's research experience has been shaped by working directly with patients as a clinical research coordinator, working with study teams as an IRB coordinator and working with sponsors to identify research sites. . As a two-time graduate of Clemson University with a master's degree in clinical and translational research, Katie is ecstatic to be working for Clemson Rural Health, increasing access to clinical trials to rural and underserved communities of South Carolina.