12/04/2024
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In September 2024, the Food and Drug Administration (FDA) released another draft guidance titled “Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs” for sponsors intending to conduct global clinical development programs (CDP) for new cancer treatments. The guidance provides advice on using evidence obtained from multi-regional clinical trials (MRCT) to support marketing applications. MRCTs are trials that are conducted in multiple countries, geographical or regulatory regions that all follow the same protocol.
CDPs that are included in MRCTs have many potential benefits including:
Facilitating new drug development: CDPs with MCRTs can simultaneously analyze multiple study populations that may vary in risk factors and treatment plans for certain diseases and can support the safe and effective use of new drugs in each participating population.
Enable early identification: when a disease is rare in one region but common in another, CDPs with MCRTs can help identify these differences and create an optimal treatment plan for the intended use population.
Improve feasibility: In regions where a disease is rare, developing a CDP may not be cost effective, CDPs with MCRTs can provide the funding required and facilitate earlier access to treatment for such diseases.
Promote efficiencies: CDPs with MCRTs reduce the need for the repetition of trials in different regions and facilitates parallel marketing applications to the various regulatory authorities of the regions participating.
Sponsors of oncology MRCTs that submit marketing applications to the FDA have the unique challenge of following the rules and regulations of multiple regulatory agencies concurrently. Additionally, to gain FDA approval, the data and evidence obtained in these MRCTs needs to be applicable and interpretable to the U.S. population and medical practices. This has been a rising issue due to the decreasing numbers of U.S. participants in these trials. Significantly different demographic or clinical characteristics from sites in foreign regions impacts the generalizability and applicability of the results and therefore may not be used as supporting evidence. The guidance provides recommendations on the planning, design, conduct, and analysis of oncology MRCTs to improve their generalizability and applicability to the U.S. population while meeting all of the relevant requirements from regulatory authorities.
The recommendations of the guidance are divided into 5 categories:
U.S. Population Representativeness in the MRCT
Considerations for U.S. and Foreign Site Selection
Disease, Available Treatment, and Medical Product Considerations
Considerations for Analyses of Data from MRCTs
Early Consultation with FDA and Other Regulatory Authorities
Comments are no longer being accepted for the draft guidance; the full document can be found at the FDA’s website, and supplementary information is provided in the Federal Register. To stay up to date on the FDA’s activity in regards to clinical trials such as draft and final guidance for industry, sign up for our blogs and newsletters today at https://www.clinicalpathwaysresearch.com/blog.
-The Clinical Pathways Team
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