[Industry Voice #20] Roche Pharma on…
Case Study: How to enroll 612 patients…
OCT Clinical has initiated a multinational phase III oncology clinical trial sponsored by a U.S.-based immuno-oncology biotech company in four Eastern European countries. This is a randomized open-label trial, the aim of which is to determine the efficacy and safety of a test drug in combination with chemotherapy and platinum as first-line therapy in patients with metastatic non-squamous cell non-small cell lung cancer.
The enrollment target for the entire global study is 560 adult patients, 360 of which are planned to be recruited by OCT Clinical at 44 research sites in four Eastern European countries: Russia, Ukraine, Georgia and Belarus. Participants will be treated until the disease progresses or intolerance to therapy develops. The duration of the project is almost 4 years, until the end of 2024.
“Initially, we planned to include 33 sites, but thanks to the dedication of the OCT clinical team, a thorough feasibility analysis and qualification visits, the Sponsor decided to increase the number of centers to 44,” commented Irina Petrova, Director of Clinical Operations, OCT Clinical.
At the moment, the study is being approved by the regulatory authorities of the study countries. The CRO has already obtained CTA approval from the authorities in Belarus. First site initiation visits are scheduled for July 2021.
Within this project, the OCT Clinical team is responsible for a wide scope of clinical trial services: study feasibility analysis and site selection, clinical trial approval and regulatory support, logistics, medical monitoring, project management, site management and monitoring.