Good Clinical Practice Journal

Below are the titles of articles published in the Good Clinical Practice Journal Volume 5 Issue 4 (July/August 1998).

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

"Impact of cultural differences in the pharmaceutical industry"
by Laura Brown

Abstract
The key elements of Hofstede's cultural layer theory which attempts to explain how culture may be understood are outlined. Examples of successful cross-cultural co-operation such as ICH, with particular emphasis on the Japanese reaction to implementing ICH GCP are given. An approach used to study the co-operation culture of a major pharmaceutical company is described. Finally, the attributes of the ideal pharmaceutical culture are considered.

"How to save a failing clinical trial"
by Roger Rosenberg and Deborah Jordan

Abstract
Before setting out to save a failing clinical trial, it is vital to determine exactly what has gone wrong. Once this has been established it is a question of going back to basics, looking at what the trial was intended to achieve and working out a compromise that will allow the trial to continue.

"Towards a perfect clinical submission Part 3: special population groups and reporting the results"
by Cecil Nick

Abstract
Issues relevant to special population groups such as patients, children, the elderly, those with concomitant disease and ethnic factors are considered. Finally, reporting of studies is discussed. The expert report is the most critical of all. It is the applicant's chance to orientate the thinking of the reviewer and avoid confusion.

"Learning to contract out clinical research"
by François Geelan

Abstract
Setting the structure for a successful relationship between an outsourcing business and its clients involves careful analysis of the needs of both sides. Pre-conceived ideas and rigid structures must be cast aside if an efficient operating procedure and realistic contract are to be realised.