The investigator’s brochure (popularly referred to as IB) is an important tool for the pharmaceutical company to share information about the new drug and its indications with healthcare professionals.
An investigator’s brochure keeps all clinical and nonclinical data on an investigational product (drug, supplement, device, or other product) under investigation. Staff constantly update the IB with the newest information throughout the drug development process. It is a critical document at every stage of drug development. Information in the IB comes from preclinical and clinical trials to aid the investigator in managing study subjects and conduct throughout clinical trials. Therefore, this document assists researchers in understanding why certain protocol features are important, such as dose, dosing schedule, and method of administration.
In this article:
- What is an investigator’s brochure
- Why do pharma companies need an Investigator’s Brochure?
- How to write an investigator’s brochure?
- Benefits of investigator’s brochure
- Sections of an investigator’s brochure
- Conclusion
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Why do pharma companies need an investigator’s brochure?
The IB is a useful document for field investigators or study personnel in the conduct of clinical studies. This includes the conduct of investigator meetings, where the healthcare professionals learn about the investigational product and its use in the study. The information in the IB is also critical for regulatory authorities and ethics committees during the review of the study protocol or during the review of the application for marketing authorisation.
How to write an investigator’s brochure?
The first step in writing an IB is to read the study protocol. The study protocol describes the study’s design, conduct and regulatory status. The protocol provides information about the study design (number of patients, dosage, duration of the study, etc.). It also describes the criteria that have to be met by the investigators and the study sites.
According to the study protocol, the next step is to read the regulatory documents for the study. In the regulatory documents, the regulatory authorities have described the requirements for conducting the study, including the conduct of the informed consent, the study protocol, the data to be collected during the conduct of the study, and the analysis and reporting of study results.
Benefits of investigator’s brochure
- An IB serves as reference material. The IB is a comprehensive compilation of clinical and nonclinical data on the investigational product that contains the body of information about the investigational product
- It is a source of the latest information. The IB is a document of critical importance throughout the drug development process; staff keep it up-to-date with new information as it becomes available
- An IB facilitates understanding of the investigational product. The IB facilitates understanding of the rationale for, and compliance with, many key features of the protocol
- It guides clinical research staff. The IB is useful for field investigators or study personnel in the conduct of clinical studies.
- For regulation purposes. The information in the IB informs regulatory authorities and ethics committees during the review of the study protocol or during the review of the application for marketing authorisation.
- It is a direct source of information regarding the proposed clinical use of the investigational product and the results of the preclinical and clinical studies.
- An IB is a data source for study participants’ informed consent process.
- It is a source of information for post-marketing surveillance.
- An IB is a source of data for pharmacovigilance activities.
Sections of an investigator’s brochure
The IB has several sections, including:
- Table of contents: The table of contents provides a guide to the contents of the document.
- Introduction: The introduction provides an overview of the clinical development of the investigational product. This includes the current development status, the product’s pharmacokinetics and pharmacodynamics, and the study rationale.
- Description of the product: This section describes the characteristics of the investigational product and the source of the product. It provides information about the product’s stability, impurities and residual solvents, if any.
- Description of the study: This section provides information about the study design, the number of subjects expected, the number of sites engaged in the study, and the duration of the study. It also contains regulatory documents.
- Description of the clinical data: This section contains the clinical data collected during the clinical trials. These data include efficacy, safety, pharmacokinetics, biobanking and patient-reported outcome data.
- Summary: The summary provides a brief overview of the data presented in the other sections of the IB.
Conclusion
The advent of digital technology has brought about many changes in the way we look at things. Similarly, the way we distribute information and the way we receive information has undergone a transformation. This transformation has led the drug developers to make their investigator’s brochure available in a digital format.
The investigator’s brochure is an important tool for the pharmaceutical company to share information about the new drug and its indications with healthcare professionals. It is a document of critical importance throughout the drug development process and is updated with new information as it becomes available
