WRITING CLINICAL INVESTIGATORS BROCHURES ON DRUGS FOR A PHARMACEUTICAL COMPANY

A clinical investigator's brochure is a summary of the preclinical and clinical information about a drug that is about to enter clinical tri als. It serves to update clinical investigators on the possible benefi ts, risks, and areas of uncertainty still left to be studied. The writ er of the clinical investigator's brochure can create a streamlined, s uccinct, and easily readable document by using a format that closely p arallels the research and the development history of the drug, as foll ows: 1) Introduction, 2) Chemistry, 3) Pharmacy, 4) Animal Pharmacolog y, 5) Animal Toxicology, 6) Animal Pharmacokinetics, 7) Clinical Exper ience, 8) Possible Risks and Precautions, and 9) Bibliography. In this article, the author explains what information is needed in each of th ese sections and suggests ways to avoid redundancy.