Top 5 Challenges For Pursuing IO Therapy Clinical Trials

By Erin Finot, MS, MBA, Vice President, Immuno-Oncology & Cell and Gene Therapy, IQVIA Biotech

Designing clinical trials for immuno-oncology (IO) therapies, particularly those involving cell- and gene-based treatments, presents unique scientific and operational challenges. To navigate these complexities, biotech and emerging biopharma companies must adopt strategic approaches tailored to key regulatory and logistical hurdles.

Proactive engagement with regulators, such as through the FDA’s Project Optimus, is crucial. This initiative helps sponsors leverage nonclinical and clinical data during dose-finding to enhance early registration trials, minimizing dose toxicities that could affect efficacy and patient quality of life. Local regulatory bodies, including Institutional Review Boards (IRB) and Institutional Biosafety Committees (IBC), also demand early involvement, particularly when dealing with the intricate safety profiles of cell-based therapies.

Selecting the right trial sites and ensuring they are well-prepared is another critical aspect. Utilizing real-world data, predictive modeling, and robust educational platforms ensures that sites can manage the protocol’s complexities and maintain data integrity throughout the trial.

Patient enrollment strategies must be precise, targeting molecular markers and diverse demographics. The growing availability of pre-screened patient pools enhances study efficiency and accelerates timelines. Additionally, the logistical demands of cell-based therapies, from manufacturing to transportation, require meticulous coordination, often across international borders.

By collaborating with experienced clinical trial partners and leveraging data-driven insights, sponsors can effectively overcome the challenges of IO trials, ultimately bringing innovative cancer treatments to market more swiftly.