Whether in private practice, group practice, or the academic medical setting, many rheumatologists participate in industry and investigator initiated clinical trials. Clinical trials are essential to the development of new treatments and involve numerous regulations and guidelines, in addition to standard practices. Failure to follow these regulations can lead to unwanted costs, audits from such regulatory agencies as the Food and Drug Administration (FDA), and the potential shutdown of a clinical research program. This article will demonstrate how the involvement of a registered nurse (RN) research coordinator can prevent deviations from or interruptions to your clinical trial, as well as enhance patient care.
Following Regulations and Guidelines
RNs follow regulations as part of regular clinical nursing practice via the Nurse Practice Act. Each state’s Nursing Practice Act provides guidance to nursing in the same way that clinical research is guided by FDA guidelines, the Code of Federal Regulations, the International Code of Harmonization, and, when applicable, foreign regulatory bodies. RNs are able to follow all of these guidelines in parallel, making them valuable research coordinators with a great understanding of the serious nature of practice rules and regulations, whether those rules relate to nursing or clinical research.
Superior Patient Care – A Case Study
A patient willingly agrees to participate in a clinical research trial. The patient signs a consent form agreeing to all legal ramifications and explanations, as well as their rights and responsibilities, but what comes next? Who is responsible, and who makes it all come together? Ultimately, the primary investigator as described in the Code of Federal Regulations 21 CFR 50.3 (25) (d) is the leader responsible for the conduct of research at a clinical site. However, primary and subinvestigators rely on the RN research coordinators to keep trials focused and organized to ensure patient safety and compliance. RNs are the comprehensive eyes and ears of our trials.
An example of the benefit of the RN research coordinator is described in the following case study:
Mr. Smith had osteoarthritis (OA) of his hip to the degree that he was having difficulty caring for himself and couldn’t work. He agreed to enroll in a clinical trial comparing oral nonsteroidal antiinflammatory drugs (NSAIDs) for the treatment of OA.
His pain was initially well controlled with the higher dose of NSAIDs per the trial protocol. A few months later, during a routine research visit, the RN research coordinator noticed a significant change in his pain and range of motion, which severely limited his mobility. The RN research coordinator communicated her observations to the primary investigator, and the patient was referred to the clinical practice for a “same-day” appointment.
The patient was anxious because he did not have medical insurance to cover the cost of this care. The RN research coordinator worked with the financial coordinator to obtain approval for a financial assistance program.
He was diagnosed with severe OA of the hip, and pharmaceutical treatment approaches were no longer sufficient to manage the disease, so he was, in turn, referred to an orthopedic surgeon. Within a month, a total hip replacement was successfully completed, and then within six months, the patient was able to return to work as a maintenance technician, for which the patient was extremely thankful.
During this time, the RN research coordinator ensured that the treating surgeon was aware of the trial and that the patient complied with the surgery instructions and study guidelines to ensure safety. Although in Mr. Smith’s case, surgery was an unexpected outcome, in the clinical trial setting, it is considered a serious adverse event, which the RN research coordinator reported to the sponsor in accordance with its guidelines.
Clinical Trial Compliance
Often, specific rules and regulations are essential for internal/external clinical trial compliance. A sponsor will provide a list of items that need to be completed at each research office visit. Let’s say, for example, Visit 1 needs to include informed consent to the protocol; history and physical; medication history for rheumatoid arthritis; current medications; review of inclusion/exclusion criteria; labs, including complete blood count, comprehensive metabolic panel, and a urine pregnancy test; and a chest X-ray (CXR).
The principal investigator obtains the consent, reviews the inclusion/exclusion criteria, and assesses the history, physical, and all medications. He then orders the labs and CXR. The RN research coordinator is able to assess, per the protocol, that the labs will not be analyzed in house except for the urine pregnancy test, which needs to be performed immediately. The RN was provided with urine pregnancy test strips that are unexpired. The RN knows that random urine pregnancy test strips are not approved for point-of-care testing following institutional regulations and therefore, prior to the start of the trial, will need to negotiate with the sponsor to utilize institution-approved products. Also, the RN needs to match up the institutional ordering practices with the protocol directions. For example, when ordering a CXR, the provider in regular clinical practice may order a PA/LAT CXR. However, the protocol may require a single-view CXR. Therefore, the RN double-checks the orders to verify the provider is aware of this and ensures that the extra views, if needed, are not part of the research charge but rather billed to the patient’s insurance as standard of care. As a result, the RN understands the clinical practices and ensures that research examinations and procedures are billed to research and that standard-of-care items are billed to insurance. Clinical trial compliance is often complicated.
Conclusion
It’s important for research teams to ensure the safety and compliance of each participating subject. Teams meet regularly to review outstanding laboratory findings, adverse events, protocol compliance, and any specific endpoint findings. The findings are categorized and reported to their corresponding institutional governing bodies and/or regulatory agencies, along with the sponsors. An open communication dialogue between the research investigator and the RN research coordinator plays a large role in ensuring the research obligations, as well as clinical practice guidelines, are adhered to in order to promote clinical trial safety and integrity.
Tara L. Barker, RN, BSN, MSN, is a registered nurse and research nurse coordinator for the Department of Rheumatology at the Cleveland Clinic in Ohio.
