Normally, as an Investigator, you will be working with an investigational product manufactured by a pharmaceutical company. For those studies, the pharmaceutical company provides the Investigator’s Brochure (IB).
However, for some clinical trials the investigational products (e.g. CAR T, PANDA-VAC, C11-AMT), are manufactured in-house at our Advanced Cellular Therapeutics Facility or other GMP facilities on UNC’s campus. Such products do not have an externally developed IB, so we may need to work with you to develop one.
When do we need to develop an IB?
An IB is not always required for sponsor-investigator INDs.
At LCCC, we develop IBs for any investigational product if one of the trials using the drug/biologic meets one of the following conditions:
- Multicenter clinical trial
- Commercial IND (e.g., includes a Phase 2 or 3 trial)
Who can help me if I need to develop an IB?
A member of our clinical development team can help you write an IB, if required. Reach out to LCCC_IND@unc.edu for assistance.
What is included in an IB?*
- Brief description of the drug substance and the formulation, including the structural formula, if known.
- Summary of the pharmacological and toxicological effects of the drug in animals and, to the extent known, in humans.
- Summary of the pharmacokinetics and biological disposition of the drug in animals and, if known, in humans.
- Summary of information relating to safety and effectiveness in humans obtained from prior clinical studies.
- Description of possible risks and side effects to be anticipated based on prior experience with the drug under investigation or with drugs in the same class, and of precautions or special monitoring to be done as part of the investigational use of the drug. Adverse Events (AEs) described in the IB help determine whether an AE that occurs during a clinical trial is “expected” and, if so, how it will be reported to FDA.
*According to FDA Guidance- E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) and https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-applications-clinical-investigations-regulatory-and-administrative-components
How long does it take to write an IB?
An IB typically takes around six months to write and have reviewed by clinical, manufacturing and nonclinical reviewers. It is important to plan in advance if you need an IB written.