By Janice “Jan” Nissen BSN, MBA, MS Pop Health, consultant, The Accreditation Council for Medical Affairs and the Foundation for the NIH
Without clinical trials, there are no new innovations to address the myriad of diseases that still need to be tackled. The science is only getting more complex, and the talent shortage among clinical research professionals is only getting worse.1 Since nurses represent the largest segment of the healthcare workforce, by sheer numbers2, I wondered why more nurses are not occupying roles in clinical research. According to Freel et al, for every clinical research nurse, there are 10 openings.1
The issue seems to be a lack of awareness of this career option among nurses. From personal experience, I gather that nurses are largely unaware of clinical research as a career option, even though many of the academic centers where they are employed are actively engaged in clinical research. Another likely reason nurses are not pursuing these roles is that they are unfamiliar with the research process. Drug, device, and diagnostic development, their regulations, and the business model are not often covered in nursing training, whether that’s baccalaureate, master’s, or doctoral programs. There are only a few academic centers and universities (such as New York University) that have now begun to develop training programs for nurses to educate themselves on research development and the associated regulations that govern it.
The role of a clinical research nurse at a clinical trial site is to care for patients who are in a clinical trial. They ensure that treatments are appropriately administered, collect data on patient response or adverse events, and protect patient confidentiality throughout the process. A nurse working at a clinical research organization and/or a life sciences company can serve as a clinical research associate, where they visit and monitor trial site recruitment, retention, diversity, and data collection for a given trial. Given their close contact with the trial participants – the patients – and their understanding of their needs, nurses play a critical role in clinical research, from helping patients understand trial requirements to navigating the informed consent process and adhering to study visits.
Nurses are uniquely set up to serve as clinical research professionals, either at their own academic center, at a contract research organization, or at a life sciences company. Here’s why:
1. Nurses are among the most trusted healthcare professionals.
Year after year, according to a Gallup poll, Americans rank nurses as the top profession for honesty and ethical standards4. When it comes to a healthy volunteer considering participation in a Phase 1 study or a patient considering whether to engage in a Phase 2 or 3 clinical trial, working with a trusted professional is critical. The trust can help a patient with a discussion on the the pros and cons of participation and gain a clear understanding of the trial requirements. Nurses are good listeners and able to effectively read patients and their body language, which can help to ensure understanding by the patient. With a trusted professional, the patient and nurse can even discuss, where needed, modifications to a protocol that may ease the logistical barriers to participation.
2. Nurses are excellent communicators.
Nurses are adept at communicating with patients, caregivers, and their families. They realize the importance of communicating in a manner that is understandable to the patient. They realize the importance of health literacy and the need for cultural sensitivity, particularly at a time when achieving health equity in clinical research is imperative.
3. Nurses are problem solvers.
The data suggests that 80% of clinical trials do not enroll on time and 55% are discontinued due to lack of enrollment.3 Nurses are comfortable synthesizing information both quantitatively and qualitatively to identify issues in enrollment and reasons for dropouts and how to use this information to develop a risk mitigation plan.
There is a real opportunity for nurses to seek a career as a clinical research professional. The demand is there and nurses are well positioned for the role. However, nurses need to educate themselves about the development process and associated regulations and whether this career option is the right fit for them.
For sponsors and CROs looking to bring more nursing staff into the fold, I suggest the following:
- Develop a fellowship program with a college of nursing. Industry has a long history of providing fellowships to Pharm.D.s and Ph.D.s. Although this group has the scientific background, they lack the knowledge of patients, sites of care, and delivery of care that nurses understand.
- Create an internship with a college of nursing in order to expose undergraduate and graduate nurses to the industry, how it operates, and its associated regulations.
- Assess your own organization to see if you have nurses already on board. Understand what brought them to industry and learn how to reach interested and qualified nurses for roles in clinical research.
This is an opportune time to expand your clinical research talent pool by focusing on nurses. Not only can you more readily attract these professionals due to the high level of dissatisfaction and burnout with traditional nursing roles within a health system, but you are able to leverage nurses’ innate understanding of the patient, who is the ultimate recipient of life sciences innovations.
About The Author:
Janice “Jan” Nissen is a nurse and a retired biopharmaceutical executive currently consulting with the Accreditation Council for Medical Affairs and the NIH Foundation.
- Freel, S, et al. Now is the Time to Fix the Clinical Research Workforce Crisis. 2023, June 2. Sage Journals. https://journals.sagepub.com/doi/10.1177/17407745231177885
- Healthcare Occupations: Characteristics of the Employed: Spotlight on Statistics: U.S. Bureau of Labor Statistics (bls.gov)
- Desai, M. Recruitment and Retention in Clinical Studies. 2020, April-June. Perspectives in Clinical Research. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7342339/