The Investigator’s Brochure (IB)
The Investigator Brochure is a document that summarizes the clinical and nonclinical data on the investigational product(s) that will be relevant to investigators undertaking clinical studies in human subjects. The investigators are responsible for providing the latest IB to the responsible IRB or Ethics Committee.
The IB should help the investigator understand the design of the proposed clinical study. For example, the IB should summarize the chemical, formulation, pharmacologic and toxicologic studies that have been used to determine the method of administration, and the dose and dosing frequency of the study drug that will be studies in the protocol. If there are known or suspected drug interactions, they should be outlined. If there have been any previous clinical studies with the drug, the IB should also summarize the pharmacokinetic, safety, and efficacy results.
The IB is usually prepare by a medical professional with the assistance and/or review by the colleagues from the disciplines that generated the data. The preparation of the IB requires more than simply cutting and pasting sections of the tox and pharm reports; the writer should interpret the data in a simple, balanced, clinically relevant manner. If the drug being studied is an approved drug and the study is being conducted for the labeled indication, the approved prescribing information (PI) may replace the IB. If the drug is being studied for a new indication, an IB specific to that proposed use should be prepared.
The IB should be reviewed at least annually and updated as needed to be sure that all relevant information is available to the investigator. More frequent updates may be needed if important new information becomes available. Sometimes new findings are so critical that they need to be communicated to the investigators and their IRBs/Ethics Committee or regulatory authorities while a revised IB is being prepared.
The FDA Guidance Document called E6: Good Clinical Practices which is referenced under Guidance Documents in the Resource section gives detailed instructions for the preparation of an IB.
The Investigator Brochure is a document that summarizes the clinical and nonclinical data on the investigational product(s) that will be relevant to investigators undertaking clinical studies in human subjects. The investigators are responsible for providing the latest IB to the responsible IRB or Ethics Committee.
The IB should help the investigator understand the design of the proposed clinical study. For example, the IB should summarize the chemical, formulation, pharmacologic and toxicologic studies that have been used to determine the method of administration, and the dose and dosing frequency of the study drug that will be studies in the protocol. If there are known or suspected drug interactions, they should be outlined. If there have been any previous clinical studies with the drug, the IB should also summarize the pharmacokinetic, safety, and efficacy results.
The IB is usually prepare by a medical professional with the assistance and/or review by the colleagues from the disciplines that generated the data. The preparation of the IB requires more than simply cutting and pasting sections of the tox and pharm reports; the writer should interpret the data in a simple, balanced, clinically relevant manner. If the drug being studied is an approved drug and the study is being conducted for the labeled indication, the approved prescribing information (PI) may replace the IB. If the drug is being studied for a new indication, an IB specific to that proposed use should be prepared.
The IB should be reviewed at least annually and updated as needed to be sure that all relevant information is available to the investigator. More frequent updates may be needed if important new information becomes available. Sometimes new findings are so critical that they need to be communicated to the investigators and their IRBs/Ethics Committee or regulatory authorities while a revised IB is being prepared.
The FDA Guidance Document called E6: Good Clinical Practices which is referenced under Guidance Documents in the Resource section gives detailed instructions for the preparation of an IB.