FDA Issues Draft Guidance on Conducting Multiregional Clinical Trials in Oncology
The FDA issued a draft guidance for conducting multiregional clinical trials (MRCT) in oncology, aiming to ensure data applicability to U.S. patients and medical practice. The guidance addresses the decreasing proportion of U.S. participants in MRCTs and aims to improve trial planning, design, conduct, and analysis.
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In Sept 2024, FDA issued 3 guidance docs to support clinical trial approaches: decentralized, routine clinical practice integration, and multiregional oncology trials. These aim to assist sponsors and investigators in efficient trial design and conduct.
FDA releases draft guidance on oncology multiregional clinical trials (MRCTs), emphasizing results must be interpretable for US patients. The guidance addresses issues raised during the review of Innovent Biologics and Eli Lilly’s cancer therapy Tyvyt, which was not approved in the US despite Chinese approval. The FDA advises sponsors to consider specific patient factors and ensure MRCT data supports safety and effectiveness in US patients.
The FDA issued a draft guidance on conducting multiregional clinical trials for cancer drugs, emphasizing the importance of data applicability to U.S. patients and medical practice. The guidance aims to improve trial design and analysis, ensuring results are generalizable to the U.S. population.
The FDA released a draft guidance on multiregional clinical trials (MRCTs) in oncology, emphasizing that results must be interpretable to US patients. The guidance addresses issues raised during the review of Innovent Biologics and Eli Lilly’s cancer therapy Tyvyt, which was not approved in the US. The FDA advises sponsors to consider specific patient factors and socio-cultural influences, ensuring MRCT data supports a robust assessment of safety and effectiveness in US patients.
FDA issued three guidance documents on Sept 16-17, 2024, focusing on modernizing clinical trial policies, including decentralized clinical trials (DCTs), routine clinical practice trials leveraging real-world data (RWD), and multiregional clinical trials (MRCTs) for oncology drugs. Key changes in the DCT Final Guidance include no task log for local HCP activities, ensuring qualifications of local HCPs, and clarifying investigator oversight. The Routine Clinical Practice Trials Draft Guidance promotes streamlined protocols and QbD principles. The Oncology MRCT Draft Guidance emphasizes U.S. population representativeness and standard of care considerations. FDA encourages early consultation with regulatory authorities and acknowledges potential challenges with non-traditional trial designs.
FDA issued draft guidance for companies conducting multi-regional clinical trials (MRCT) for cancer drugs, emphasizing the importance of ensuring trial data applicability to the US population. The guidance aims to improve the generalizability and applicability of MRCT results to US medical practice.
The FDA issued a draft guidance for conducting multiregional clinical trials (MRCT) in oncology, aiming to ensure data applicability to U.S. patients and medical practice. The guidance addresses the decreasing proportion of U.S. participants in MRCTs and aims to improve trial planning, design, conduct, and analysis.