Breast cancer research and the European Union Clinical Trials Directive.
Running clinical trials in the commercial sector has always been associated with a certain amount of bureaucracy due to the stringent requirements needed to bring a new drug onto the market. Noncommercial trials have largely been performed outside these requirements. New legislation brought about as a result of the implementation of the European Union Clinical Trials Directive will change this two-tiered approach by harmonizing regulations in all member states. Those who run noncommercial clinical trials will have to find cost-effective ways of dealing with this legislation if such work is to continue in Europe.
Williams
Norman
N
Clinical Trials Group of the Department of Surgery, Royal Free and University College Medical School, University College London, London W1W 7EJ, UK. n.williams@ctg.ucl.ac.uk
D001943:Breast Neoplasms / Q000188:drug therapy*; D002985:Clinical Protocols / Q000592:standards; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D028744:Ethics Committees, Research / Q000639:trends; D005062:European Union; D006801:Humans; D017410:Practice Guidelines as Topic / Q000592:standards