A therapy tested in a clinical trial does not necessarily involve a drug not already in clinical use. A new
treatment often consists of standard drugs used in a new combination or a new sequence, in new dosages or
even simply given in a new way. But if a new drug is involved and the Phase III trial is successful, the Drugs
Directorate of Health and Welfare Canada will approve the drug for general use. Eventually, the new therapy
might become the standard therapy.
Clinical Trials and the "Approved" Uses of Drugs When using anticancer chemicals, it is important for both you and your doctor to be aware of how the pharmaceutical industry works. Once drug companies have fulfilled the lengthy and complex testing— and the drawn-out legal procedures— required to market a new drug, they tend not to devote a lot of effort to discovering new uses for that drug. They more or less delegate this responsibility to the cancer physicians conducting clinical trials .
But every drug comes with an official "package insert" detailing what dose to use for what illness. This information is also listed in the Compendium of Pharmaceuticals and Specialties (CPS). These summaries usually contain only the information "passed" by the government's approval agencies. Why this is important is that many drug programs in standard use are not listed as "approved." They are used because experience with patients has shown they are effective. About half of all the current uses of anticancer drugs in the United States and Canada are for indications and schedules not given in the official inserts.
