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.
