Key Elements of an Investigator’s Brochure
By: Arooj Fatima
An investigator’s brochure is used to provide comprehensive information about a drug, obtained before and during its clinical trials. The brochure is updated regularly as the trial progresses; a change is made in the drug, and after it has been approved to be prescribed or sold in the market.
Investigator’s brochures are useful compilations of data regarding all aspects of a trial drug. Interpreting Services and Translation Services can be used to translate them into different languages in order to promote a product internationally. For example, Armenian Investigator’s Brochures Translation Services will be used by drug manufacturers of Armenia.
The information given in an investigator’s brochure must be straight forward and be presented in a way that does not look like advertising. The first part of the brochure is a ‘summary’ of one to two pages that provides a sophisticated abstract of all the following sections. Next in line is the introduction which includes a detailed outline of the drug to be investigated.
The introduction includes the scientific and market names of the product, its active ingredient and the clinical development plan. After this you need to mention the physical and chemical properties of the drug with respect to its individual components. The data provided in this section should be adequate for the investigator to evaluate associated side effects of the drug.
You can always refer to investigator’s brochures published by renowned pharmaceutical companies to get a clear idea of the format. For instance, if you are willing to follow the layout or design of an Armenian brochure, you can make use of Armenian Investigator’s Brochures Translation Services.
The section concerned with Pharmacological properties shall also give instructions for appropriate usage, storage and handling of the product. Then comes the part in which you have to describe the non-clinical aspects of the drug, i.e. findings discovered before initiating clinical trials with human subjects.
You may add accounts of various tests and experiments conducted on lab species. Results shall assess toxic effects or negative impacts of the drug and how these can be corrected or possibly reversed. It is a good practice to support your data with tables and figures.
Then comes the section concerned with clinical studies conducted on human beings. Here you will identify the effectiveness and safety of the drug in correlation with varying doses. Dosage can be changed in amount or frequency; you will specify the techniques you used. The major contribution in data comes from the second and third phase of the trials.
Finally you will provide the post marketing assessment of the drug’s efficiency. This may include statistics formulated from reviews given by medical specialists who prescribed your product, as well as patients who have used it. In the end you shall briefly sum up everything for further guidance of the investigator; also mention any expected additions or alterations to your product.
If you are writing an investigator’s brochure for a foreign company, request for Interpreter Services to boost understanding of their product. You can also carry out personal research and take advantage of resources like Armenian Medical and Healthcare Investigator’s Brochures Translation Services for learning about Armenian drugs and clinical trials.