They undermine the value of the recommendations. As discussed in the previous issue of the Newsletter , the Report deals with the question whether and how people suffering from a catastrophic illness could obtain faster access to investigational drugs. The Emergency Drug Release Program Traditionally, the EDRP has been used in emergency cases, when drugs approved elsewhere are necessary to treat a disease rarely occurring in Canada. Over the last decade, it has become one of the most important ways to obtain new investigational drugs that are not yet approved in Canada. However, the paperwork involved, the loss of time due to the obligation to obtain permission from the Drug Directorate, and the individual character of each permission have been criticized.
Clinical trials aim at testing the safety, toxicity and efficacy of an investigational new drug.
Very often, these novel drugs or treatments are not available outside a clinical trial and many people participate in a trial with the desire to improve their health and to contribute to the development of a cure. There are some problems, though. Trials require time, not all people can participate, and of those who participate many receive only the control drug or placebo instead of the investigational drug. The Report discusses these problems and makes some interesting recommendations. There is, for example, a clear recommendation to implement a new system of conditional approval for drugs designed to treat life-threatening conditions and to develop guidelines for compassionate access to investigational therapies before 1 June 1997.