Using Innovative Trial Designs To Accelerate Drug Oncology Development

By Martin Roessner, Corporate Vice President, Biostatistics

In the realm of oncology clinical trials, urgency is paramount as patients seek life-saving treatments, spurring drug developers—both large enterprises and biotechs—to innovate. Parexel is at the forefront, advocating for flexible trial designs that allow adjustments post-initiation, facilitating adaptive approaches to patient categorization and treatment. These designs encompass safety and efficacy evaluations with interim milestones for informed decision-making.

Master protocols, a cornerstone of this approach, offer versatility by assessing multiple therapies across various indications concurrently. Basket designs focus on single therapies across diverse indications, while umbrella designs target multiple therapies for a single disease. Platform designs extend flexibility to include future therapy additions or exclusions. Real-world data integration enhances trial efficacy, especially in rare diseases, supporting innovative regulatory pathways.

However, implementing these designs demands careful consideration of trial complexity, operational challenges, and cost-effectiveness. Parexel emphasizes best practices like clear protocol objectives, proactive collaboration, and early regulatory engagement to optimize outcomes in oncology research and accelerate treatment advancements. Learn more by reading the full article below.