The Times has uncovered incidents of widespread exploitation of the doctor-patient relationship in which patients agree to take part in whatever their doctor asks. Dr. Fiddes, himself, claimed at his interrogation that many others were engaged in dubious activities. Since they are paid for each patient they recruit, researchers have an enormous financial incentive to cheat. When pharmaceutical companies pass their submissions for new drugs to the FDA and Health Canada, the names of all investigators providing patients' data are listed, but there is not revealing information about any of the participants. Ian MacKay, a member of Health Canada's Bureau of Pharmaceutical Assessment of the Therapeutic Products Programme, makes it clear that stringent checks and balances are applied to all submissions before any product can be accepted.
Requests can come from small companies, large firms or individual researchers.
Our view is that, for the last few years, with the advent of a number of very important international guidelines, the roles and responsibilities for conducting trials and the various roles within these trials are very well delineated. These two sets of principles provide a very, very solid basis for guiding practitioners in the conduct of clinical trials. They have the responsibility of ensuring that researchers have the background, experience and knowledge to conduct these sorts of trials. He also points out the importance to Health Canada of pivotal trials that have two large components, one in the U.S. for example, and another in an international setting. Should these two not reflect the same spectrum of results, the trial would not be considered valid.