What is the main purpose of an "investigator's brochure"?

The primary purpose of an investigator's brochure is to provide essential information about a drug that is undergoing clinical trials. This document serves as a comprehensive resource for investigators involved in a study, containing critical information such as the drug's pharmacology, safety data from prior studies, the rationale for proposed clinical studies, and detailed instructions on how to conduct the trial.

By consolidating relevant data, the investigator's brochure aids in ensuring that all clinical trial staff are adequately informed about the investigational drug, its intended use, potential risks, and how to monitor and report adverse effects. This thorough understanding is crucial for compliance with regulatory requirements and for protecting the safety of trial participants.

While it might include information about potential side effects, its overarching purpose is broader, focusing on providing comprehensive and essential details concerning the drug being tested. Unlike promoting the drug or seeking funding, the investigator's brochure serves a regulatory and ethical function to facilitate informed and safe clinical research practices.