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Lessons learned from investigator-initiated clinical trials for localized pancreatic cancer
1LaBahn Pancreatic Cancer Program, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
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.
Insights
Investigator-initiated trials (IITs) empower clinicians to lead research, optimizing therapies when industry or cooperative groups lack support. Surgeons play a key role in developing these vital clinical trials.
Area of Science:
- Clinical Research
- Surgical Innovation
- Medical Trials
Background:
- Investigator-initiated trials (IITs) are crucial for advancing medical treatments.
- IITs facilitate research not typically supported by industry or cooperative groups.
- Clinicians serve as both sponsors and investigators in IITs.
Discussion:
- The investigator's role in IITs is comprehensive, encompassing protocol design, funding acquisition, subject recruitment, and ethical oversight.
- Surgeons are vital in developing IITs, contributing clinical expertise and driving research relevant to surgical practice.
- Understanding and overcoming logistical challenges are crucial for successful IIT execution.
Key Insights:
- IITs provide a critical platform for advancing medical knowledge and treatment paradigms.
- The comprehensive responsibilities of an investigator require strong organizational and leadership skills.
- Surgeons' involvement in IITs can lead to significant advancements in patient care and surgical techniques.
Outlook:
- Future IITs will likely focus on personalized medicine and innovative treatment modalities.
- Addressing logistical barriers through collaborative efforts and streamlined processes will enhance IIT success rates.
- Continued surgeon engagement in IITs is essential for translating research into clinical practice.
