Good Clinical Practice Journal

Below are the titles of articles published in the Good Clinical Practice Journal Volume 7 Issue 6 (September 2000).

Copies of back issues and individual articles are available direct from the publisher � please contact us for further information.

"Regulatory aspects of the application of pharmacogenetics in drug discovery and development in Europe"
by Lisbeth Knudsen and Jan Rennerberg

Abstract
Genetic testing as part of clinical trials is a relatively new entity that requires strict regulation and control, and the involvement of ethics committees.

"Current regulations in gene therapy"
by Jayne Spink

Abstract
No single authority oversees the conduct of gene therapy clinical research at the level of the European Union. Regulation of safety, efficacy and ethical acceptability is subject to review by different bodies according to the country where the trials are performed. In view of the relatively extensive nature of the UK experience, current issues and considerations in relation to the oversight of gene therapy clinical trials are highlighted, with particular reference to the UK regulatory system.

"Culyer- an effective approach to R&D in the NHS?"
by David Galloway

Abstract
In this overview of the Culyer report, David Galloway gives comprehensive cover to its background, politics, aims, results and conclusions.

"Statistical quality in analysing pharmaceutical clinical trials"
by Professor Stephen Senn

Abstract
Against a background of shifting paradigms of statistical inference but increasing statistical regulation, Stephen Senn, Professor of Pharmaceutical and Health Statistics at UCL (University College, London), considers what makes for statistical quality in pharmaceutical clinical trials.