Summary
This case study details a Phase I-II clinical trial managed by Fortrea, focusing on a personalized neoantigen-based vaccine for patients with non-small cell lung cancer, colorectal cancer, and gastroesophageal cancer. The document outlines the rigorous site selection, training, and logistics processes employed to recruit and enroll eligible patients. Fortrea's approach included activating high-performing sites with expertise in personalized oncology, conducting extensive sample management training, and developing a strict logistics process to ensure timely handling of fragile samples. The study involved 190 screened patients, with 30 recruited and 29 enrolled across 12 activated sites in the USA and Australia. The case study emphasizes the importance of communication and project management in the success of complex precision oncology studies. Fortrea's high-touch approach and meticulous planning led to the successful regulatory submission of the immunotherapy, advancing it to a randomized Phase II-III trial after reporting positive results from the initial trial.
