Track 52: Investigator-Initiated Trials

Overview: Investigator-Initiated Trials (IITs)

Investigator-Initiated Trials (IITs) are clinical studies where the idea, protocol development, and trial execution are led by an independent researcher or academic investigator, rather than a pharmaceutical or biotech company. These trials are crucial for exploring scientific questions, off-label drug uses, novel combinations, or local healthcare challenges that may not be prioritized by industry sponsors. IITs contribute significantly to real-world evidence, expand medical knowledge, and may support new indications or treatment approaches. Although they may receive funding, drug supply, or logistical support from companies, the investigator retains full control and responsibility over the design, conduct, and publication of the trial.

Key Sub-Topics in Investigator-Initiated Trials:

Protocol Design and Concept Development · Academic and Hospital-Based Trials · IRB/Ethics Approval Process · Budget Planning and Funding Sources · Drug Supply and Material Transfer Agreements · Regulatory Submissions (e.g., IND/CTA) · Data Management and Monitoring · Publication and Dissemination of Results · Collaboration with Industry or Nonprofits · Investigator Responsibility and Liability · Real-World Evidence Generation · Safety Reporting and Pharmacovigilance · Trial Registration and Transparency · Training and Site Management · Challenges in IIT Oversight and Compliance