Good Clinical Practice Journal

Below are the titles of articles published in the Good Clinical Practice Journal Volume 5 Issue 3 (May/June 1998).

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

"Guarding the pharmaceutical chicken coop: the case for external clinical auditors"
by Douglas Mackintosh and Bernette Molloy

Abstract
The development of financial auditing as a rigorous and professional discipline is described. The application of a number of tenets of financial auditing practice are discussed and applied to the clinical research arena. The case for using independent external auditors to review clinical research data is made. A number of examples where internal auditing has failed to prevent the inclusion of fraudulent data are highlighted.

"Insuring international clinical trials:the killjoy of the harmonisation process"
by Genevieve Decoster and Jim Smith

Abstract
Increasingly rapid worldwide acceptance of clinical data for drug approval allows fast access to effective medicines. The lack of harmonization within the International Conference on Harmonisation (ICH) region regarding insurance for clinical trial subjects slows down the entire clinical trial process as Sponsors need to work through a regulatory maze.

"Do outcomes reflect real life?"
by Julia Bottomley

Abstract
There is an increasing interest and explosion in outcomes measurement and monitoring in all healthcare sectors. In the UK market in particular, there is a growing drive to find evidence to support decision-making and purchasing of healthcare to secure value for money. Increasingly, purchasers and providers of healthcare will become accountable for their decisions and care provision. This review discusses the climate and need for outcomes data. It outlines opportunities to obtain these data and highlights a number of issues which need to be addressed in ensuring outcomes have their desired impact, namely improving healthcare.

"Towards a perfect clinical trial submission. Part 2: Phases II and III clinical trials"
by Cecil Nick

Abstract
Phase II explores the clinical potential of a drug and should provide a clear idea of dosage. Phase III confirms the findings of Phase II and should avoid ambiguity by assigning only a few end points per study. End points ought to be clinically relevant. Safety must be demonstrated in a sufficient number of patients from as broad a population base as possible.