Clinical Trial Subinvestigator: An Emerging Role for Oncology Nurse Practitioners

Clover Patterson1, Fedricker D Barber1

  • 1University of Texas MD Anderson Cancer Center.

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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