DRUG STUDY INVESTIGATOR BROCHURES SHOULD INCLUDE INTEGRATED SAFETY/EFFICACY DATA -- ICH DRAFT GUIDELINE; ESSENTIAL DOCUMENTS DRAFT GUIDELINES AVAILABLE
Executive Summary
Integrated safety and efficacy data summaries from previous trials of an investigational drug should be included in brochures provided to clinical investigators, the International Conference on Harmonization draft document on "Good Clinical Practices: Guideline for the Investigator's Brochure" states. "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.