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.
You may also be interested in...
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Shire Hopes To Sow Future Deals With $50M Venture Fund
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth