Ge. Pakes, WRITING CLINICAL INVESTIGATORS BROCHURES ON DRUGS FOR A PHARMACEUTICAL COMPANY, Journal of technical writing and communication, 23(2), 1993, pp. 181-189
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.