What does an Investigator's Brochure contain?

The Investigator's Brochure is a crucial document that is designed to provide comprehensive information about an investigational product to investigators and other involved personnel. It contains clinical and nonclinical data that includes details about the product's pharmacology, toxicology, and efficacy, as well as any previous clinical studies conducted with the product. This information is essential for investigators to understand the product being studied, any potential risks, and how it may behave in human subjects.

Having this thorough background aids in ensuring that investigators are adequately informed to conduct the study safely and ethically, and to make decisions regarding patient care during the trial. This information helps in formulating the study protocol and developing informed consent documents, ultimately contributing to the integrity and safety of the research process.

In contrast, financial disclosures relate to potential conflicts of interest and do not typically form part of the Investigator's Brochure. Study progress reports focus on updates about the study's trajectory and outcomes, which are separate from the foundational information provided in the brochure. Meta-analyses summarize findings from multiple studies, but this analytical approach is not included in the Investigator's Brochure, which focuses on data specific to the investigational product rather than synthesizing results from various studies.