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Published on: September 20, 2019
Clinical Trial Subinvestigator: An Emerging Role for Oncology Nurse Practitioners
Clover Patterson1, Fedricker D Barber1
1University of Texas MD Anderson Cancer Center.
Abstract:
Phase 1 clinical trials are essential to improving outcomes in cancer care. The investigational agents in these trials may be associated with adverse events that can contribute to symptom burden and declining performance status for trial participants. The emerging role for oncology nurse practitioners (ONPs) as subinvestigators offers a unique practice setting for advanced practice nurses. In this role, ONPs provide expert oncology care, are responsible for swift recognition and management of adverse events, and ensure adherence to the clinical trial protocol.
Insights
Oncology nurse practitioners (ONPs) are crucial in phase 1 cancer trials. They manage adverse events and ensure protocol adherence, improving patient care and trial integrity.
Area of Science:
- Oncology Nursing
- Clinical Trial Management
- Advanced Practice Nursing
Background:
- Phase 1 clinical trials are vital for advancing cancer care.
- Investigational agents can cause adverse events, impacting patient well-being and performance.
- Advanced practice nurses are increasingly involved in clinical research.
Purpose of the Study:
- To highlight the expanding role of oncology nurse practitioners (ONPs) as subinvestigators in phase 1 cancer trials.
- To emphasize the importance of ONPs in managing treatment-related toxicities.
- To underscore the ONP's contribution to maintaining clinical trial integrity.
Main Methods:
- This is a conceptual/practice-based abstract, not reporting empirical results.
- Focuses on the described responsibilities and contributions of ONPs in phase 1 trials.
- Literature review and expert opinion synthesis regarding the ONP role.
Main Results:
- ONPs provide expert oncology care within the unique setting of phase 1 trials.
- ONPs are integral to the early recognition and management of adverse events.
- ONPs play a key role in ensuring participant safety and adherence to trial protocols.
Conclusions:
- The role of ONPs as subinvestigators is essential for successful phase 1 cancer trials.
- ONPs enhance patient safety and optimize the management of toxicities.
- Integrating ONPs strengthens the infrastructure for cancer clinical research.
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