Investigator's Brochures (IBs) are complex and multidisciplinary documents that provide investigators and ethics committees with a broad overview of a product's development. A well-written IB that contains precisely the information needed relative to the current stage of development saves time on all fronts – for review by investigators and ethics committees as well as for preparation of subsequent updates.
In drug development, the Investigator's Brochure summarises the main elements of the entire development programme to date, primarily for the benefit of investigators conducting clinical studies. In addition to information on the investigational product itself, the IB provides an overview of non- clinical and clinical findings together with guidance for investigators on the use of the product based on medical interpretation of these findings.
Section 7 of ICH E6 provides what is essentially a table of contents that is almost always used unchanged. The highest level sections are:
- Summary
- Introduction
- Physical, chemical, and pharmaceutical properties and formulation
- Non-clinical studies
- Effects in humans
- Summary of data and guidance for the investigator.
Information in the IB should enable a clinician, or potential investigator, to understand it and make his/her own unbiased risk-benefit assessment of the appropriateness of the proposed trial. The overarching challenge when preparing an IB is to achieve a concise and focused presentation style, finding an appropriate balance between completeness and readability. Ultimately, of course, the IB should be both complete and readable. An IB should ideally be reworked at the time of each update so that the overall length still remains a maximum of ~100 pages.
MedTrans has years of experience helping its clients to write concise and well-structured IBs.
Our understanding of clinical development and its demanding timelines enables us to help clients plan and produce IBs in a timely manner to support their ongoing clinical programmes. Contact us today to find out how our IBs writing expertise can help you.