Treating Patients Enrolled in Clinical Trials

All oncology nurses-not just nurse researchers-will need to understand the fundamentals of clinical trials as patient access to the studies continues to expand.

All oncology nurses—not just nurse researchers—will need to understand the fundamentals of clinical trials as patient access to the studies continues to expand, according to Denise Friesema, MS, RN, OCN®, University of Chicago Medical Center, Illinois. At the Oncology Nursing Society (ONS) 37th Annual Congress, Friesema discussed issues that arise when treating a patient who is enrolled in a clinical trial.

When the clinical trial involves an investigational agent, nurses need to educate themselves about the drug. Friesema said that nurses can learn about the treatment by reading the clinical trial protocol, reviewing the investigator brochure, or conducting a search of any available literature.

Caring for patients in clinical trials also introduces new issues with documentation. “Documentation that is acceptable in clinical practice may need additional details to be acceptable in clinical research practice,” Friesema said. She added that staff nurse documentation is critical to the clinical trial process. “It is from this documentation that protocol-specific data are abstracted from and transferred to case report forms,” Friesema noted.

Important areas of documentation for clinical trial participants include drug administration, disease response, and adverse events. With drug administration, nurses need to document adherence to trial protocol, the start and stop times of dose administration, and any medications taken or fluids consumed before or after treatment. Due to patient self-administration, documentation of oral agents presents additional challenges. “For oral agents, it is important for nurses to have the patient complete a diary to document home dosing,” Friesema said.

When documenting disease response (eg, tumor growth), nurses should refer to the clinical trial protocol. Friesema said the protocol should explain how the disease should be measured, when the measurements are to be conducted, and what criteria should be used to define the response. The general measurement standard for solid tumors is the Response Criteria in Solid Tumors (RECIST), ” and there are various international standards for liquid tumors.

Friesema said that it is also critical to document all adverse events and report them to the research team. She said that in addition to informing investigators and regulators about ongoing treatment developments, the monitoring of adverse events is used to develop a toxicity profile for a drug or regimen.

Blood sample collection, known as “pharmacokinetics” or “pharmacodynamics,” is another important component of treating a patient enrolled in a study. Samples are taken at various intervals before, during, and after treatment. The samples are used to examine drug levels in the body and quantify a drug’s toxic and therapeutic effect, according to Friesema. She said to ensure that a patient remains “valuable” to the study, staff nurses need to adhere to the collection times established in the protocol, not miss any samples, collect complete samples, and ensure the samples are appropriately processed.

For oncology nurses interested in learning more about clinical trials, Friesema said that ONS is hosting an online course this summer called, “Clinical Trials Awareness on a Global Level.” Details will soon be made available at


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