The Development of Investigator-Initiated Clinical Trials in Surgical Oncology.

Authors :: McDonald HG
Cassim EB
Harper MM
Burke EE
Marcinkowski EF
Cavnar MJ
Pandalai PK
Kim J
Source :: Surgical oncology clinics of North America [Surg Oncol Clin N Am] 2023 Jan; Vol. 32 (1), pp. 13-25. Date of Electronic Publication: 2022 Nov 03.
Publication Year :: 2023
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.<br />Competing Interests: Disclosure No financial support was received from any commercial interest in the production of this research. The remaining authors declare no potential conflicts of interest.<br /> (Copyright © 2022 Elsevier Inc. All rights reserved.)