The Nurses’ Role in a Clinical Trial: Everyone Is Involved

By Kristie L. Kahl

Nurses can serve in a variety of roles when it comes to clinical trials — from being a research nurse or a vital piece of the multidisciplinary team, according to Maria Hendricks, MSN, RN.

“Each and every one of you is involved in the care of a research patient. Your role is integral in the success of how we treat our patients moving forward,” Hendricks, director, clinical research operations, Abramson Cancer Center, Clinical Research Unity, University of Pennsylvania in Philadelphia, said during a presentation at the 3rd Annual School of Nursing Oncology.

Clinical Trials

Clinical trials are designed to study new drugs that are not yet approved by the FDA; new uses of drugs that are already FDA approved; new ways to administer the drugs; use of alternative medicines; new tests to find and track different cancer types; and drugs or procedures that alleviate symptoms.

Phase I studies are intended to find a safe dose of the drug, to decide how the new treatment should be given, and to see how the new treatment affects the patient and treats their respective cancer. This phase of studies typically includes 15 to 30 patients.

Phase II studies determine if the new treatment has an effect on a certain type of cancer. They also evaluate how the new treatment affects the individual and their disease. This phase typically involves less than 100 patients.

Lastly, phase III trials are designed to compare the new treatment, or new use of said treatment, with the current standard treatment, with or without placebo. This phase involves anywhere from 100 to several thousand patients.

The multidisciplinary care team on a clinical trial includes a physician (principal investigator or sub-investigator) and an advances practice provider, including:

  • Nurse Practitioner (NP)
  • Physician Assistant (PA)
  • Clinical Research Nurse (RN)
  • Clinical Research Coordinator (CRC)
  • Pharmacist/Pharmacy Technician
  • Biospecimen Coordinator
  • Regulatory Coordinator
  • Research Assistant (RA)

Clinical Research Nursing

As it includes all advanced practice competencies, clinical research nursing involves decision making and concrete thinking.

“It is a key focus of study management, human subject protection, care coordination — which is very complex when it comes to trials. Overall, it contributes to science in addition to using baseline clinical practice knowledge for the support and care of an oncology patient,” Hendricks explained.

In particular, there is a difference between a research nurse and a nurse researcher — roles that often get confused with one another. A clinical research nurse contributes to science with a focus on the care of the research participant and the coordination of research activities in a research practice setting, Hendricks explained. Meanwhile, a nurse researcher provides a significant body of knowledge to advance nursing practice, shape health policy, and impact the health of patients, she added.

The role of the research nurse includes determining consent and screening; eligibility criteria; treatment; grade and attributing toxicities; dose modification; concomitant medications; disease response; and deviation reporting.

“The research team of nurses is a key piece to be aware of. There is some additional training that is required. There is some education around what it is to do good clinical practice when it comes to the care of a research patient,” Hendricks said.

“It is taking a look at financial disclosures. It is making sure there is appropriate training about what happens on the study,” she added.

Act Seeks to Expand Clinical Trial Access to Patients on Medicaid

By Brielle Benson, Feb 20, 2020

ASCO representatives visit Capitol HillClinical trial routine care costs (including X-Rays, lab work, doctor visits and more) are not covered for people who are insured by Medicaid, leading to certain groups being underrepresented in clinical trials. However, the Clinical Treatment Act (H.R. 913) is trying to change that.

“The Treatment Act is really about ensuring accessibility for Medicaid patients for participation,” Dr. Melissa Dillmon, the Chair of the Association for Clinical Oncology’s (ASCO) Government Relations Committee said.

ASCO is one of more than 100 organizations that urged Congress this week to include the act in the upcoming “must pass” health care extenders package that is expected to be passed on May 22, 2020.

The Clinical Treatment Act would ensure that all patients on Medicaid have coverage of routine procedures and checkups associated with clinical trials. This could potentially boost the participation of minorities, who tend to be overrepresented in the Medicaid population, but underrepresented in clinical trials.

“It’s important when we look at clinical trials – especially in cancer – that we have racial and socioeconomic diversity so that it can be used in the real-world setting,” Dillmon said.

Representative Ben Ray Luján (D-NM) and Representative Gus Bilirakis (R-FL) introduced the act, which currently has 28 cosponsors representing both parties. Additionally, organizations such as the American Medical Association and the American Cancer Society Cancer Action Network have also voiced their support for the bill.

While some may be apprehensive to support H.R. 913 because they think it could increase costs, Dillmon said that is not true.

“One of the concerns is the financial part, and I hope we’re able to dispel that myth,” Dillmon added, noting that some states in the U.S. already have Medicaid coverage for clinical trial care costs, and there have been no reported increased costs there. And since the pharmaceutical company usually pays for the drug being tested, costs could even go down.

“Logically, one may think costs of care may go down. If the patient is on a clinical trial, there is no bill to Medicaid for the drug, and that’s often one of the most expensive parts of treatment,” Dillmon said.

Clinical trials are crucial to moving the field of cancer – and other serious illnesses – forward. The more patient populations they can include, the better outcomes can be for more Americans.

“Oncology has seen unprecedented successes right now in our treatment for cancer. We’ve had the single biggest improvement in the reduction in mortality. Our goal as physicians is to continue that fight and have even more survivors,” Dillmon concluded.

Advocate ‘Walks the Talk’ Regarding Cancer Clinical Trials

By Brielle Benyon, March 12, 2019

Clinical trials are about more than just collecting data – they’re about survivorship and family. This was the focus of Rose Gerber’s talk at the CURE Patient-Focused meeting at the 36th Annual Miami Breast Cancer Conference.

“There are different stakeholders in clinical trials,” said Gerber, a breast cancer survivor herself and the director of Patient Advocacy and Education at the Community Oncology Alliance (COA). COA’s mission is to advocate for the preservation of cancer care – especially when it comes to community cancer practices.

“When we think about clinical trials, to me in my mind, it’s about survivorship and family.”

Gerber was involved in a clinical trial, testing the efficacy of trastuzumab (Herceptin). She said that her oncologist referred her to the trial, but everyone on the treatment team plays a role – including the scientists conducting the trials, doctors, oncology nurses, and patients – in not only discussing clinical trials, but also the important concept of informed consent where patients have a full understanding of the trial, willingly decide to participate, and continue their consent through the duration of the trial.

“We all need to work together,” Gerber said. “It should be patient-centered, but it takes all of us.”

While Gerber was referred to a clinical trial by her care team, there are also other resources that oncology nurses can discuss with their patients, including websites for major cancer centers, and other resources such as the Susan G. Komen Foundation,, and the American Society for Clinical Oncology’s (ASCO) website. hosts information for all cancer clinical trials in the United States. And while Gerber mentioned that some have said that the website is not patient-friendly, it is uplifting to see the amount of research that is being conducted.

“Despite all the criticism, around this site, it’s pretty phenomenal. There are over 4500 studies on breast cancer. That’s fantastic for all of us,” she said.

But despite all these resources, there are also barriers that patients face when it comes to enrolling in clinical trials. They range from personal perceptions – including lack of awareness, distrust, and financial concerns – to logistical problems, such as the need for childcare for additional appointments and transportation issues.

“My big issue was that I needed to get home for the 11 a.m. school bus,” Gerber, who had 2 young children when she was diagnosed with early-onset breast cancer, said.

Another common assumption is that patients can only enroll in a clinical trial if they are being treated at an academic institution. But Gerber stressed that this is not the case.

“Great trials are already happening in the community setting,” she said.

Gerber hopes that by increasing engagement in clinical trials and engaging community leaders as clinical trial ambassadors, more patients can overcome these barriers. From both a professional and personal standpoint, adding that she has a goal of educating people about clinical trials.

“I believe let’s walk the talk,” she said. “One of the ways that we can overcome barriers is to have somebody patients can trust – another patient like them who enrolled and can talk about the experience.”