Medical College of Wisconsin
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Lessons learned from investigator-initiated clinical trials for localized pancreatic cancer. J Surg Oncol 2022 Jan;125(1):69-74

Date

12/14/2021

Pubmed ID

34897709

DOI

10.1002/jso.26756

Scopus ID

2-s2.0-85120941585 (requires institutional sign-in at Scopus site)   2 Citations

Abstract

Investigator-initiated trials (IITs) are clinical trials in which the clinician is both the sponsor and the investigator. IITs have also been developed to test strategies designed to optimize existing therapies or treatment approaches that may not be supported by industry sponsors or may be too novel to gain the consensus to be supported by cooperative groups. The role of the investigator is comprehensive and includes protocol development, securing funding for the administration of the trial, recruitment and monitoring of subjects, and assurance for the protection of human subjects. We will briefly review the importance of surgeons in developing IITs and provide insights into logistical barriers from conception to completion of the trial.

Author List

Tsai S, Evans DB

Author

Douglas B. Evans MD Professor in the Surgery department at Medical College of Wisconsin




MESH terms used to index this publication - Major topics in bold

Clinical Protocols
Clinical Trials as Topic
Humans
Pancreatic Neoplasms
Surgical Oncology