Advanced Practice Providers Are Poised to Boost Community Involvement in Clinical Trials

Involvement in clinical trails and referrals for patient enrollment are factored into the standard regimen of care for oncology advanced care providers (APPs) associated with academic centers and large cancer institutions. However, for those in the community setting several barriers to clinical research prevent APPs and their patients from taking part in experimental therapies.¹

According to data from the American Society of Clinical Oncology’s (ASCO) annual Practice Census, the number of oncology practices in the United States that have reported employing APPs increased from 52% in 2014 to 81% in 2017.^2,3 A collaborative effort of ASCO, the American Academy of Physician Assistants, the Association of Physician Assistants in Oncology, the Advanced Practitioner Society of Hematology and Oncology, and the Oncology Nursing Society led to the identification of 5350 oncology APPs practicing in the United States, with the possibility of that number being close to approximately 7000.

APPs are involved in various aspects of care including roles as nurse practitioners (NPs), physician assistants (PAs), and other licensed, nonphysician providers such as clinical nurse specialists, certified nurse midwives, and certified registered nurse anesthetists.² NPs are regulated and licensed by state nursing boards, although requirements for recertification and continuing education vary.⁴

Furthermore, approximately half of states authorize NPs to independently practice without the need for oversight,^5,6 and all states grant full prescriptive authority for NPs.⁵ Additionally, PAs are also regulated by state medical boards and must practice with a supervising physician, with extent of physician supervision varying by state.^6,7 PAs are able to write prescriptions in all states.⁸

APPs in Clinical Trials

APPs associated with institutions often fill roles in clinical trials as primary investigators (PIs), subinvestigators, study coordinators, and/or in the delivery and monitoring of therapies for patients. Results from a 65-item survey of attitudes, beliefs, and roles of oncology APPs in clinical research that was distributed via the Association of Community Cancer Centers (ACCC) demonstrated that oncology APPs are engaged and interested in clinical trials, and believe clinical research is important to improve care. However, they may not be used to their full scope.⁹

Barriers include a lack of time, inadequate awareness of clinical trials, and underrepresentation on research committees. Recommendations for realizing the potential of APPs include research-related education, more complete integration as a member of the multidisciplinary cancer care team, and federal and state policy and regulatory changes.

“I work with 1 other oncologist, and we keep a portfolio of our available trials,” Christa Braun-Inglis, MS, APRN, FNP-BC, AOCN, of the University of Hawaii Cancer Center in Honolulu, told OncLive^®. “I’ll see a patient for treatment counseling, and I’ll assess whether or not [a patient is] eligible for either a treatment trial or symptom management trial that we have available. [The oncologist and I] have this workflow where she will introduce the trial during the consult and then I’ll pick up from there during the treatment counseling, and I will decide whether or not they are eligible and interested in enrolling in the trial.”

Braun-Inglis, who is the primary author of the study and an oncology NP, emphasized that her experience with clinical trials and clinical research has been in the community setting at the University of Hawaii Cancer Center. She explained that she functions within the National Cancer Institute (NCI)-sponsored Community Oncology Research Program, where she is PI on several quality-of-life, symptom-control cancer care delivery protocols. She also noted that she provides clinical support to the research coordinators.

Laura J. Zitella, MS, RN, ACNP-BC, AOCN, of the University of California San Francisco Helen Diller Family Comprehensive Cancer Center, said she works at an academic medical center with a very robust clinical trials program. “My primary role is the clinical care of patients, and in that role I take care of patients who are receiving standard-of-care treatments,” Zitella said. “But I also take care of patients who are enrolled in clinical trials. I am a subinvestigator on clinical trials that are related to the patient population that I care for.”

Zitella, a hematology/oncology NP, said she includes clinical trials in treatment discussions with patients and communicates with the primary trial investigator and the clinical research coordinator to enroll patients in trials. “I am involved with consenting and performing research procedures, and ordering study drugs, and all of the other processes that go along with being [enrolled in] a clinical trial,” she said. “It’s very common for APPs at academic medical centers to be involved with clinical research and to be subinvestigators on clinical trials for the patient population that they take care of.”

Lisa A. Kottschade, MSN, APRN, CNP, an NP at Mayo Clinic in Rochester, Minnesota, said, “Oncology APPs can play a number of roles in clinical research. Some things that come to mind include patient recruitment and management on clinical trials [or] serving as principal investigators on certain trials and coinvestigators. Additionally, APPs can participate in NCI cooperative groups and institutional research committees. I belong to our cancer center’s scientific review committee and our data safety monitoring board.”

Current Challenges for APPs

In the community setting, Braun-Inglis noted that very few APPs are enrolling their patients in trials even though they can do so for trials in the symptom management/ quality-of-life cancer care delivery space. Based on the survey findings, over 70% of APPs would like to have a larger role in clinical research (Figure^2,9). “I want us to really participate to the extent that our licensure, our scope, and our role within our institutions will allow,” she said.

Figure. Snapshot of APPs in Oncology Practice^2,9

Braun-Inglis also emphasized that there is no formal training available for APPs at this time, but access to initiatives could be beneficial in 4 areas:

• How to assess a patient for a trial in everyday practice•
• How to become a good investigator and follow good clinical practice
• How to review a study protocol for feasibility and scientific integrity
• How to play a role in protocol development and leadership

This year, the Advanced Practitioner Society for Hematology and Oncology (APSHO) launched a research and quality task force to identify needs within the APP community, with a goal to develop curriculum that APPs can access. “We still see only 3% to 5% of adult oncology patients going on trials,” Braun-Inglis said. “Here we are, a group of health care providers that has grown exponentially in the last 10 years. We’re not being routinely engaged in this process. I think the interest is there; now [the question is] how do I do this at my practice?”

Zitella noted that an area of opportunity for oncology APPs is to be educated and aware of clinical trials and to be able to discuss them as a potential treatment option for patients. “There are a number of organizations trying to increase awareness and education about clinical trials for APPs, including APSHO and ACCC,” she said. “I think that if people are involved with professional organizations, go to meetings and network with other oncology APPs, and hear about what other people are doing...that makes a difference.”

APPs Can Shape the Future of Clinical Trials

Currently, APPs are not able to order drugs or treatments for Cancer Therapy Evaluation Program (CTEP)-sponsored trials or any drug that holds an investigational new drug application, all of which contribute to a substantial barrier in practice.

In September 2020, the NCI developed a guideline that allows APPs to sign for drugs for nontreatment trials. “Even though there is that guideline that exists now, it’s still fuzzy,” Braun-Inglis explained. “You meet barrier after barrier. Our whole platform is to allow us to practice at the top of our licensure and scope within the realm of trials and not have the trial or the sponsor of the trial limit our practice. I’m hoping in the next couple of years or even a year that we’re going to see the changes come from the CTEP-sponsored trials. My real push is to make APPs leaders for other trials because we do all those things every day. There is no reason that we shouldn’t have a significant amount of involvement.”

Zitella said there has been a significant shift in the last year because the NCI clarified some of the responsibilities of nonphysician investigators. “All cooperative groups now have nursing committees, and I think that we are going to see more progress in integrating APPs into those roles,” Zitella said. “I think the other area where we’re going to see a lot of progress is integrating the patient; this is a key element for the future of clinical trial design. Academic medical centers, professional organizations, cooperative groups, and the NCI are really trying to partner with community oncology practices to make it easier and more feasible to conduct clinical research and to have them be a part of clinical trials.”

Kottschade noted that clinical trials in oncology are often the best option for patients for treatment, and in some cases, the only option and that APPs will affect the extent to which clinical trials are leveraged in the community setting. “The use of APPs in the community setting will expand access for patients to be enrolled on clinical trials, through increased awareness, education, and access,” she said.

Braun-Inglis added, “I would love for APPs to take a look at their practice, look at the clinical research available in their practice, and really evaluate [how they can be] practicing at the top of their scope and licensure.”

Zitella emphasized the importance of always considering clinical trials as treatment options. “Even if you don’t work in clinical trials, being aware of them, knowing where to find them and feeling comfortable discussing them with patients, is really important because patients are relying on us for our opinion and for our knowledge,” she said.

References

1. Kurtin SE, Taher R. Clinical trial design and drug approval in oncology: a primer for the advanced practitioner in oncology. J Adv Pract Oncol. 2020;11(7):736-751. doi:10.6004/jadpro.2020.11.7.7
2. First large-scale survey of advanced practice providers in oncology shows growing role for nurse practitioners and physician assistants. News release. American Society of Clinical Oncology. August 22, 2018. Accessed July 7, 2021. https://www.asco.org/about-asco/press-center/news-releases/first-large-scale-survey-advanced-practice-providers-oncology
3. Bruinooge SS, Pickard TA, Vogel W, et al. Understanding the role of advanced practice providers in oncology in the United States. J Oncol Pract. 2018;14(9):e518-e532. doi:10.1200/JOP.18.00181
4. Cooper RA, Henderson T, Dietrich CL. Roles of nonphysician clinicians as autonomous providers of patient care. JAMA. 1998;280(9):795-802. doi:10.1001/jama.280.9.795
5. Sarzynski E, Barry H. Current evidence and controversies: advanced practice providers in healthcare. Am J Manag Care. 2019;25(8):366-368
6. Naylor MD, Kurtzman ET. The role of nurse practitioners in reinventing primary care. Health Aff (Millwood). 2010;29(5):893-899. doi:10.1377/hlthaff.2010.0440
7. Fairman JA, Rowe JW, Hassmiller S, Shalala DE. Broadening the scope of nursing practice. N Engl J Med. 2011;364(3):193-196. doi:10.1056/NEJMp1012121
8. Kartha A, Restuccia JD, Burgess JF Jr, et al. Nurse practitioner and physician assistant scope of practice in 118 acute care hospitals. J Hosp Med. 2014;9(10):615-620. doi:10.1002/jhm.2231
9. Braun-Inglis CM, Boehmer L, Zitella LJ, et al. Role of oncology-advanced practitioners to enhance clinical research. J Clin Oncol. 2020;38(suppl 29):95. doi:10.1200/JCO.2020.38.29_suppl.95