Good Clinical Practice Journal

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

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

"The challenge of megatrials"
by Hugh Watson and Andrew Foxley

Abstract
The scale of these trials leads to immense organisational challenges and, if the expense involved is to be controlled, sponsors and organisers must look for more cost-effective ways of configuring and running the trial.

"Some thoughts on the possible impact of the proposed European Clinical Trials Directive"
by Pamela Charnley Nickols

Abstract
The intention of this review is to raise awareness of possible issues and to kindle debate on the impact of the proposed European Clinical Trials Directive. It does not represent criticism of former or present research methods employed in either pharmaceutical industry-sponsored research or non-industry-sponsored research. However, an important message to be conveyed is that quality must be evident and, to use the apocryphal Food and Administration quote, "if it's not recorded, it's rumour".