viernes, 28 de septiembre de 2018

FDA Releases Draft Guidance titled “Master Protocols – Efficient Clinical Trial Design Strategies to Expedite Development of Cancer Drugs and Biologics”





Today, the U.S. Food and Drug Administration (FDA) announced the availability 
of the draft guidance Master Protocols- Efficient Clinical Trial Design Strategies to Expedite Development of Cancer Drugs and Biologics.

Because of the growing interest in master protocol trial designs, which are
complex due to concurrent evaluation of multiple drugs and/or disease populations
within a single trial, as well as their potential regulatory impact, it is important that
the trials are well-designed and well-conducted to ensure patient safety and to
obtain quality data that may support drug approval. This guidance provides advice
to pharmaceutical sponsors, the academic community, institutional review boards,
and the public on aspects of master protocol designs and trial conduct that pose
additional regulatory consideration, such as biomarker development and statistical
analysis considerations, and provides advice on the information that sponsors
should submit to FDA and how sponsors can interact with FDA to facilitate efficient review.

Sponsors who anticipate developing drugs under a master protocol are strongly
encouraged to communicate with FDA early in the development program to obtain
feedback on the design of the protocol before submitting an investigational new drug (IND).

Please refer to the guidance or the Federal Register notice for more information

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