DRUG STUDY INVESTIGATOR BROCHURES INCLUDING INTEGRATED SAFETY/EFFICACY DATA
This article was originally published in The Tan Sheet
Executive Summary
DRUG STUDY INVESTIGATOR BROCHURES INCLUDING INTEGRATED SAFETY/EFFICACY DATA summaries from previous trials of an investigational drug are recommended in an International Conference on Harmonization draft document on "Good Clinical Practices: Guideline for the Investigator's Brochure," which was announced in the Aug. 9 Federal Register. "The use of integrated summaries on safety and efficacy by indication may provide a clearer and more informative presentation of the data" than individual study summaries, the guideline suggests.