Bridging the Investigator Gap: The Potential of PAs and NPs in Clinical Research

The landscape of clinical research is undergoing a remarkable transformation, with physician assistants (PAs) and nurse practitioners (NPs) emerging as pivotal players. As the healthcare industry grapples with a shortage of doctors, these advanced practice providers are poised to step up and fill the void, bringing their unique expertise and patient-centric approach to the forefront of investigative studies.

Overcoming Industry Challenges

The healthcare industry is facing a critical shortage of doctors, including those involved in clinical research, due to factors such as retirements and fewer new doctors entering the field. According to the Association of American Medical Collegesthe United States will experience a physician shortage of approximately 86,000 by 2036.

In addition to creating a concern about access to medical care, the declining number of medical doctors poses a significant challenge to maintaining the pace of clinical development leading to new medical treatments. With fewer practitioners available to evaluate and address patients’ health problems, the number of patients per practitioner will increase and the time available to perform research will compete directly with the time needed to treat patients. The result will be a strained healthcare workforce with little capacity to innovate and bring new treatments to market.

Additionally, a relatively small number of physicians participate in clinical research with a little over 32,000 PIs operating worldwide in 2020.  Compounding this problem, about 66% of physicians filling out an FDA Form 1572 never will fill out another.  This one-and-done effect attenuates the pool of potential investigators and makes the prospect for finding replacement experienced investigators increasingly more difficult.

The Untapped Potential of PAs and NPs in Clinical Research

NPs and PAs have the background to take on the role of investigator roles. They receive extended training in performing physical exams, conducting clinical assessments, writing prescriptions, and diagnosing diseases. They can perform these responsibilities independently or while collaborating with a physician depending on local, state, and federal regulations. Further training can be provided by implementing mentorship programs. The programs allow experienced principal investigators to guide NPs and PAs in taking on the complexities of clinical research studies.

As we prepare advanced practitioners for more involvement in leading clinical trials, it is essential for sites to foster strong sponsor relationships and advocate for advanced practitioners as clinical research investigators. Advanced practitioners with experience in clinical trials are more likely to gain acceptance in senior clinical research roles when sponsors are familiar with their backgrounds and capabilities.

Despite the widespread recognition of PAs and NPs’ contributions, there hasn’t been sufficient progress in attracting candidates to the clinical research field. For instance, a 2021 survey of advanced practitioners found that 97% felt that clinical trials were important and 70% expressed interest in being more involved in trials. However, only 35% of advanced practitioners have pursued opportunities in the field of clinical research.

Patient-Centric Perspective

One of the hallmarks of NPs and PAs is their patient-centered approach to care. They are adept at building rapport with patients, understanding their needs, and ensuring their well-being. This patient-focused perspective is invaluable in research for recruitment, retention, and adherence to protocols. Additionally, clinical research allows the opportunity for PAs and NPs to work in the field of cutting-edge investigational product development, expanding these services to diverse patient populations, and making a direct impact to the patients both sitting across from us during the assessments as well as future generations to come.

Advanced practitioners’ team-oriented approaches to medical care in clinical settings are crucial skills necessary for success in the research field. NPs and PAs are often relied upon to bridge any communication gaps between patient and physician. Such communication skills are essential in facilitating successful clinical trial execution with colleagues, sponsors, and patients.

NPs and PAs often provide continuity of care that extends beyond the confines of a clinical trial. This continuity fosters trust and encourages patient engagement, leading to more diverse populations and better overall outcomes in research studies.

Expanding the Talent Pool

To address the shortage of clinical research investigators, we need to actively engage more PAs and NPs. An important factor is to increase communication and education about clinical research opportunities while PAs and NPs are still pursuing their degrees. One helpful approach to boosting advanced practitioner involvement is through bolstering clinical research as an essential component of PA and NP education. Presenting clinical research as a viable and rewarding career path during their education can cultivate a new generation of investigators equipped with the necessary knowledge and enthusiasm.

Another effective approach to increasing PA and NP involvement in clinical research is by emphasizing its importance as a core component of their professional development. Educational institutions and training programs can incorporate hands-on research experiences and partnerships with clinical research organizations to provide practical exposure. By reaching out prior to licensure, the clinical research sector could encourage more of these professionals to pursue careers in this domain.

For advanced practitioners, the benefits of working in the clinical research field are abundant. For one, clinical research can offer a better work-life balance compared to traditional clinical settings. Clinical research follows a more standard schedule, allowing for a life outside of work.

The role of clinical research is diverse, exposing you to various tasks daily. For instance, the role may include evaluating participants for trial enrollment, establishing a treatment plan, and providing direct patient care. These varied tasks fulfill the desire for many PAs and NPs to continue to multitask, but on an achievable level as compared to clinical practice.

By delegating certain responsibilities to NPs and PAs, physician investigators can alleviate their workload and improve clinical trial participant and data oversight. This collaborative approach optimizes resource utilization and enhances the efficiency of operations.

Shaping the Future of Clinical Research

PAs and NPs are poised to play an increasingly influential role in shaping the future of clinical research. With their patient-centric approach, clinical expertise, team-oriented mindset, and dedication to advancing medical knowledge, these professionals are well-equipped to drive meaningful change within the industry.

NPs and PAs often work in underserved communities and have firsthand experience addressing healthcare disparities. Involving them in research allows us to better understand the needs of diverse populations and develop more inclusive and equitable interventions.

Currently, sponsors need to rely on the approximate 30,000 clinical investigators for successful patient enrollment in clinical trials. With more than 71,000 nurse practitioners and 125,000 physician assistants in the United States, the pool of skilled practitioners who could assume the responsibilities of Investigators with the right training is expanded exponentially. Even if 10% or less participated in clinical trials, this number of potential new investigators could substantially improve the pace of clinical research.

Discover how IMA Clinical Research’s site network and experienced staff, including several PAs and NPs, can support your clinical trials. Contact us today to learn more about our innovative solutions and how we can help advance your research and bring new treatments to patients.

Resources

Association of American Medical Colleges. (n.d.). New AAMC report shows continuing projected physician shortage.  https://www.aamc.org/news/press-releases/new-aamc-report-shows-continuing-projected-physician-shortage

Badu, Samuel. (2023, March 23). The role of advanced clinical practitioners in clinical research. The British Journal of Nursing. https://pubmed.ncbi.nlm.nih.gov/36952363/

Braun-Inglis, Christa. (2022, August 12). Better Late Than Never: Fully Incorporating Oncology Advanced Practice Providers into Cancer Clinical Trials. JCO Oncology Practice. https://ascopubs.org/doi/10.1200/OP.22.00224

Eggleston, Alice. (2024, July 6). PA Experiences in Clinical Trials. Journal of the American Academy of PAs. https://journals.lww.com/jaapa/fulltext/9900/pa_experiences_in_clinical_trials.119.aspx

Getz, Kenneth. (2021, December 7). Tracking Change in the Global Investigative Landscape. Applied Clinical Trials.https://www.appliedclinicaltrialsonline.com/view/tracking-change-in-the-global-investigative-site-landscape

Lewis, Colleen. (2022, April). The Advanced Practice Role in Clinical Trials: Past, Present, and Future. Journal of Advanced Practice. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9126353

Saunders, C. The role of nurse practitioners as principal investigators for clinical studies. Research Practitioner. https://scholars.duke.edu/publication/726443