Acceptance of Foreign Clinical Data

Abstract

The United Kingdom (UK) regulatory agency is concerned only with the quality of clinical data supporting licence applications, and not with its geographical source. This approach is determined not only by the legal implications of the UK Medicines Act and the European Economic Community (EEC) Directives but also by the recognition that medical science is an international activity. Exceptions to the general rule are well understood (eg, ethnic factors) but do not occur frequently.

The major problems in assessing clinical data are therefore related to the quality of the trials. Detailed guidelines on the conduct of clinical trials are issued by the UK and the EEC. Despite this guidance, one commonly finds that inadequate attention has been paid to the design, execution, and analysis of clinical trials. To some extent, this is due to the lack of technical facilities or trained personnel in different units or in different countries. More commonly it is related to the lack of acceptance by investigators of the crucial importance of well designed, well controlled studies.

The above comments relate to the use of foreign clinical data to support safety and efficacy before marketing. Equally important is the need to recognise that other foreign clinical data, for example, adverse drug reaction reports, are crucial in evaluating drug safety after marketing.