The Development of Investigator-Initiated Clinical Trials in Surgical Oncology

Surg Oncol Clin N Am. 2023 Jan;32(1):13-25. doi: 10.1016/j.soc.2022.07.003. Epub 2022 Nov 3.

Abstract

Investigator-initiated trials (IITs) are designed by principal investigators who identify important, unaddressed clinical gaps and opportunities to answer these questions through clinical trials. Surgical oncologists are poised to lead IITs due to their multidisciplinary clinical practice and substantial research background. The process of developing, organizing, and implementing IITs is multifaceted and involves important steps including (but not limited to) navigating regulatory requirements, obtaining funding, and meeting enrollment targets. Here, the authors explore the steps, methodology, and barriers of IIT development by surgical oncologists and highlight the importance of IITs in oncology.

Trial registration: ClinicalTrials.gov NCT04779554 NCT04276090 NCT05150652 NCT05052723 NCT04088786.

Keywords: Clinical trial protocol development; Investigator-initiated trials; Surgical oncology.

Publication types

  • Review
  • Research Support, Non-U.S. Gov't
  • Research Support, N.I.H., Extramural

MeSH terms

  • Humans
  • Medical Oncology
  • Oncologists*
  • Research Personnel
  • Surgical Oncology*

Associated data

  • ClinicalTrials.gov/NCT04779554
  • ClinicalTrials.gov/NCT04276090
  • ClinicalTrials.gov/NCT05150652
  • ClinicalTrials.gov/NCT05052723
  • ClinicalTrials.gov/NCT04088786