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Trials and Tribulations

December 30, 2021

Clinical inquiry is the backbone of drug development and expansion of therapeutic options. The conduct of clinical trials is an arduous process requiring a matrix of regulatory, financial, scientific, and clinical processes and personnel. Advanced practitioners (APs) play an integral role in the clinical trials process by serving as primary investigators, sub-investigators, study coordinators, or in the clinical management of patients enrolled in these trials.1 APs are often the first to see patients on clinical trials who are experiencing acute or unexpected adverse events, documenting these in the medical record, and completing attestation documents for grading.

In larger academic institutions, APs are commonly integrated into disease-specific research teams and assist in the review and selection of potential protocols, site initiation visits, screening and consent of patients, and implementation of any protocol updates. In some cases, APs are members of the Institutional Review Board (IRB) and serve on scientific review committees.

In this edition, three of my esteemed colleagues, Beth Faiman, PhD, CNP, of Cleveland Clinic; Lisa Kottschade, APRN, CNP, of Mayo Clinic; and Colleen Lewis, NP, of Winship Cancer Institute, Emory University discuss the role of the AP in conducting clinical research.

Sandy Kurtin, PhD, ANP-C, AOCN
Associate Editor, ASH Clinical News

Beth Faiman, PhD, CNP
Certified nurse practitioner at the Cleveland Clinic in Cleveland, Ohio
Lisa Kottschade, APRN, CNP
Melanoma nurse practitioner at Mayo Clinic
Colleen Lewis, NP
Director of clinical operations, phase I clinical trials program at Winship Cancer Institute of Emory University

In the research programs at your institutions, how are APs involved in launching clinical trials and recruiting patients?

Colleen Lewis, NP: At Emory, we established a consult clinic alongside our phase I program. I run the clinic independently and our physician colleagues across disease groups refer patients to us when they have either exhausted standard of care or other disease-specific trials. Once we receive a referral, our research nurse performs a prescreen to create a list of viable trial options based on the chart review and our portfolio availability. I then use that profile to select a trial when I see the patient for an independent visit. I am also a member of our scientific review committee and help evaluate trials for feasibility before they are even opened.

Lisa Kottschade, APRN, CNP: I do the same thing at Mayo Clinic. As an AP on our scientific review committee, I am involved with the approval process for trials.

Beth Faiman, PhD, CNP: Many of us, especially experienced APs, sit on these committees. We are approached by sponsors and we also work to open investigator-initiated studies. We have a critical role in evaluating whether studies are feasible. For example, if a phase I study requires more sampling and testing and has a greater administrative burden on the research team, we can be a voice of reason to find resources that support our nursing staff or the research assistant without overloading them.

Ms. Kottschade: At our institution, before every half-day clinic, our clinical research professionals (CRPs) talk with us about patients to consider for trial enrollment, based on their review of records and/or scans from that day. APs must be well-versed in the clinical trial portfolio at our site and are often the ones who know the patients best. We can capitalize on that familiarity by making sure that APs are informed about the clinical trials open at our sites.

Dr. Faiman: Absolutely. At many clinics, APs function independently. They often follow and monitor their own cohort of patients, because sometimes patients and their caregivers naturally latch onto the AP rather than a physician. APs can bring the patient perspective to the discussion of clinical trial participation. Disease groups within those institutions can leverage these unique relationships to connect patients with clinical trials. At Cleveland Clinic, APs participate in weekly tumor boards, presenting patients and the clinical trials that were discussed as an option at the time of disease progression.

What are the barriers to engaging APs and recruiting patients into clinical trials?

Dr. Faiman: Clinician bias is a challenge, meaning that APs might not offer clinical trials to a patient because we think that they would not be interested. Overcoming this barrier can open opportunities to create more diverse trial populations by enrolling more patients from underrepresented groups.

Time and familiarity with the process are other challenges. In my practice, we set aside administrative or protected time for research purposes to help support APs in becoming familiar with the clinical trial protocols. We make sure everyone is a trained sub-investigator, so everyone has a vested interest in each study.

Ms. Lewis: It can be rigorous work. Taking care of patients with cancer is challenging in and of itself, then there is the additional layer of navigating all the inclusion and exclusion criteria to confirm you are within the confines of the protocol. It is a fast-paced, complex environment that you need to be passionate about and naturally gravitate toward. Some providers may find it far too tedious, but I find it fascinating.

Once a study has launched, what are the AP's typical responsibilities? Do they work independently or alongside other providers?

Dr. Faiman: APs are perfectly capable of seeing patients for toxicity checks and can act as a liaison to the physician while patients are on clinical trials. In my opinion, that is why the AP role was established: to collaborate with others on meeting a mutual goal of excellent patient care.

Ms. Lewis: APs provide continuity of care for trial patients. It is certainly a collaborative effort with our physician colleagues but, in my program, we are expected to autonomously manage trial participants and become expert on caring for their needs, while also managing the implications of the trial protocol. It has been rewarding having the confidence of my physician colleagues to make that possible.

Ms. Kottschade: In my institution, APs – rather than radiologists – do our own measurements for scans. We are responsible for making sure that measurements are accurate and consistent.

Our clinical trials team at Mayo Clinic incorporates the broader clinical team. The only programs with longstanding, formal clinical research nurse roles are our phase I and breast cancer programs, which we are in the process of expanding. The CRPs in most of our programs are unlicensed personnel, and we have just hired several more who will work across all the disease groups.

Ms. Lewis: Symptom intervention is an area where APs shine in conducting clinical trials. We can help patients have the best of both worlds: access to novel drugs that may have unexpected and at times serious side effects and access to APs who have expertise in managing adverse events, allowing the patient to continue treatment.

Ms. Kottschade: My physician colleagues are clear that symptom management is not their area of expertise. They defer much of that decision-making to us. Because APs are more frequently in clinic and see trial patients more often than physicians do, we are more familiar with the patient.

Dr. Faiman: We also do toxicity assessments, including grading and attribution, during study visits. For example, at Cleveland Clinic, depending on the type of trial, research assistants working with the registered study nurses come to us and say, "This patient is having side effects that might be related to the drug. What do you think?" or "This patient on an amyloidosis study is having more edema. Is it related to their underlying amyloidosis or a side effect of this new medication?" Hopefully, many of us have the support of our disease team to allow us to make recommendations for managing those side effects.

How are APs uniquely positioned to meet the needs of trial protocols?

Dr. Faiman: APs are an integral part of the team in many research programs. In my role, I feel valuable because I help people manage their side effects and alleviate their concerns so that they can stay on clinical trials. In my experience, APs are great at "selling" the benefits of clinical trial participation. I tell patients, "You're going to have a nurse, nurse practitioner, physician, or physician assistant working with you to make your appointments, make sure your finances are taken care of, and even find some support for driving to and from the clinic."

APs' flexibility in scheduling also helps meet the needs of the patients, especially during the pandemic, and minimizes the frequency of visits. That flexibility helps participants to stay on studies, as well.

Ms. Kottschade: Great point, particularly for those trials that require two or three visits per week. APs are much better positioned to meet those protocol requirements than other providers.

Dr. Faiman: Yes, we let our patients know most visits will be with the AP. Frequently, physicians see patients for the first day of the study for consenting and the final chemotherapy appointment, according to the protocol, then they see an AP for a few months before going back to the physician.

What is the role of the AP after clinical trials are completed? Is publishing a part of your responsibilities?

Dr. Faiman: In many cases, APs are critically involved in disseminating the research, but it depends on whether the trial is investigator-initiated or industry-sponsored. In addition to writing and assisting in the preparation of manuscripts, many APs are listed on abstracts submitted to major medical meetings and present locally, nationally, and even internationally. Presenting is an important way to disseminate findings, but also to highlight our roles in conducting clinical studies.

It's rewarding to know that you put 30 patients on a phase III trial that served as the basis for a drug's approval, and to have your name on that manuscript. That was not the case 15 years ago. It was much more challenging. APs have worked hard to elevate our practice within clinical trials – but we ultimately do it to help our patients.

Do you run into issues with being able to work to the full scope of your practice?

Dr. Faiman: Levels of scope of practice vary by institution. For example, some institutions allow APs to write for investigational chemotherapy, while others require APs to write in collaboration with the other research team members. Even at my center, there are certain studies I can write for and others I cannot.

Ms. Kottschade: Agreed. There is some national drive to expand that; unfortunately, none of us can write for National Cancer Institute (NCI) trials.

Dr. Faiman: We're hoping to change that, though. I did write for an NCI investigational new drug study as the principal investigator (PI), but it was a non-chemotherapy study. APs need to jump through so many hoops to be able to do that.

Ms. Lewis: APs are all sub-investigators at my institution. That was not the case when I first started participating in phase I research. Years ago, I was a "lone ranger," the only AP dedicated to research, but so many more are involved now. We have set a standard on the disease teams that, if your APs are going to see trial patients, they need to be sub-
investigators who know the trial protocol and can operate at that caliber. That has taken some time to achieve.

How do you see the role of APs in clinical research evolving in the future?

Dr. Faiman: As an AP, being a PI in clinical trials is something that has taken a long time to recognize. Acceptance criteria is rigorous within each organization institution and then nationally, depending on the type of study. But, at the end of the day, practitioners can do their own research.

Right now, I am working on research into patient-reported outcomes (PROs) collected asynchronously at their homes, in between visits, to see whether they line up with clinical trials data. For instance, PROs in the clinical trial might differ from those of a patient who was not fit enough to participate in the study due to factors like age or organ dysfunction. I'm gathering that rich patient information and then trying to address their symptoms.

Ms. Lewis: You raise a good point about how interventional trials would never come to fruition without people in the background who are working on data management research. All these new drugs have side effects that we need to manage because a drug cannot be effective if a patient cannot stay on it. APs recognize that importance because we are spending more time with patients in clinic. Often, we are the point of contact for clinic nurses or research nurses for help with symptom management.

Dr. Faiman: APs are well poised to identify candidates for clinical trials, see them regularly, assess for toxicities, and intervene with those toxicities. APs are also capable of partnering with the research team and conducting their own clinical trials as primary investigators in symptom management or otherwise. I look forward to APs taking a larger role as clinical investigators and researchers in the next five years.

Ms. Lewis: We could hope!


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.


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