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The Development of Investigator-Initiated Clinical Trials in Surgical Oncology

Hannah G McDonald1, Emily B Cassim1, Megan M Harper1

  • 1Division of Surgical Oncology, University of Kentucky, 800 Rose Street C224, Lexington, KY 40508, USA.

Surgical Oncology Clinics of North America
|November 21, 2022
PubMed

Insights

Surgical oncologists can lead investigator-initiated trials (IITs) to address clinical gaps. Developing these oncology trials involves regulatory navigation, funding, and enrollment, highlighting IITs' crucial role.

Area of Science:

  • Oncology
  • Clinical Trials
  • Surgical Oncology

Background:

  • Investigator-initiated trials (IITs) address unmet clinical needs identified by principal investigators.
  • Surgical oncologists are well-positioned to lead IITs due to their clinical expertise and research experience.

Purpose of the Study:

  • To explore the process, methodology, and challenges of developing IITs by surgical oncologists.
  • To emphasize the significance of IITs in advancing oncology research and patient care.

Main Methods:

  • Review of the multifaceted process of IIT development.
  • Identification of key steps: regulatory navigation, funding acquisition, and participant enrollment.

Main Results:

  • IIT development is complex, requiring careful planning and execution.
  • Surgical oncologists possess the necessary skills to lead these critical research endeavors.

Conclusions:

  • IITs are vital for addressing critical gaps in oncology.
  • Surgical oncologists play a pivotal role in driving innovative clinical research through IITs.
Keywords:
Clinical trial protocol developmentInvestigator-initiated trialsSurgical oncology

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