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Writing an Investigators Brochure

Writing an Investigators Brochure

An Investigator’s Brochure (IB) is a comprehensive document that provides essential information about a drug or biologic agent under investigation in a clinical trial. The IB is intended to provide clinical investigators with the information necessary to conduct the study and ensure the safety of study participants. Here are some key steps to follow when writing an Investigator’s Brochure:

  1. Gather information about the drug: Collect all available information about the drug, including preclinical and clinical data, pharmacokinetics, pharmacodynamics, safety data, and formulation.
  2. Organize the information: Organize the information in a logical and easy-to-follow format. The IB should be structured in a way that allows investigators to quickly find the information they need.
  3. Include a summary of the drug: Begin the IB with a summary of the drug, including its mechanism of action, pharmacokinetics, and pharmacodynamics.
  4. Describe the preclinical data: Provide a summary of the preclinical data, including animal pharmacology, toxicology, and safety data.
  5. Describe the clinical data: Provide a summary of the clinical data available for the drug, including Phase 1, 2, and 3 clinical trials. Include information on safety, efficacy, and dosing.
  6. Provide information on safety and tolerability: Include information on adverse events, safety signals, and serious adverse events observed in preclinical and clinical studies. Also, include information on dose-limiting toxicities and safety concerns.
  7. Describe the formulation and packaging: Provide information on the formulation and packaging of the drug, including instructions for storage and handling.
  8. Provide information on drug interactions: Include information on drug interactions, including interactions with other drugs and with food.
  9. Include information on special populations: Include information on the use of the drug in special populations, such as pregnant women, children, and elderly patients.
  10. Include references: Include a list of references for all the data presented in the IB.

Overall, Writing an Investigators Brochure requires careful organization and attention to detail. It is important to provide comprehensive and accurate information to clinical investigators to ensure the safety of study participants and the success of the clinical trial.

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