BioCentury
ARTICLE | Politics & Policy

EMA to update antimicrobial, cancer trial guidelines

January 16, 2019 11:38 PM UTC

EMA is seeking public input on planned revisions to its guidelines on the development of cancer treatments and antimicrobials. The agency is updating its cancer guidance to include the use of biomarkers in development, and aligning its antimicrobial clinical evidence requirements with the U.S. and Japan.

EMA's Oncology Working Party proposed in a concept paper published Monday to revise the agency's cancer therapy guidelines to reflect the evolution of biomarker usage in cancer trials, as biomarker-driven studies such as basket and umbrella trials are not described in the current guidelines. The revised guideline will address the main considerations for using biomarkers and describe the main features of innovative trial designs. The agency is accepting public comments on the proposals until April 14. A first draft of the guidelines will be released in 2Q19...

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