Challenges with Investigator-Initiated Trials: Limited Budgets, Expertise & Capabilities Means Help is Needed

Dr. Harsha Rajasimha, Founder and CEO of Jeeva Informatics, highlights the importance and value of Investigator-Initiated Trials (IITs) in gathering real-world data on the efficacy, alternate uses, treatment comparisons, and cost-effectiveness of licensed drugs. Led by researchers in academic settings, IITs benefit doctors, patients, and the research community by addressing practical drug- or device-use questions and/or influencing policies by converting off-label uses into guidelines or recommendations. IITs generate diverse population data, enhancing drug safety insights. However, IITs face similar operational challenges associated with clinical trial execution as industry-sponsored clinical trials but receive significantly lower budgets.  TrialSite has reported that only about 30% of IITs are even regularly monitored. Principal investigators of IITs can benefit greatly by partnering with a cost-effective protocol-to-submission solution provider centered around AI-powered unified platform technologies that automate research workflows and data management.  TrialSite generally agrees with the problem statement hence the exposure to Dr. Rajasimha’s Jeeva Informatics.

Importantly shaping Rajasimha’s mission was the personal experience of losing a child born with a rare congenital disorder and a brother with a chronic disease.  Rajasimha’s quest was shaped by these experiences, applying  his years of postdoctoral research experience at the NIH and FDA to accelerate therapies for rare and common conditions.