Clinical Guidelines Session

In introducing this session, Dr. Laurence made the following observations: 1. In most countries, attempts at regulation of drug registration began after the thalidomide catastrophe. In the U.K. the regulation of drug development was originally based on the assumption that regulators would be reasonable if drug companies provided good scientific studies. 2. Opinions can (and do) differ about what is “reasonable.” These differences have resulted in increased attention to the idea of guidelines in the U.K. and elsewhere. The request for guidelines in the U.K. has come mainly from the companies. 3. Although there is general agreement among members of the scientific community that guidelines should be flexible, they are in fact often interpreted quite rigidly as minimal requirements.