Good Clinical Practice Journal

Below are the titles of articles published in the Good Clinical Practice Journal Volume 8 Issue 7 (July 2001).

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Note from the Editor
A clinical trial takes a while to start. It is a time-consuming and expensive business. What about ending a trial? This month's comment is about such an event. In a paper published in the British Medical Journal on 10 March 2001 � 'Premature discontinuation of a clinical trial for reasons not related to efficacy, safety and feasibility' � Michel Lievre, Joel Menard et al presented a summary of their trial and the reasons why it was stopped.

The French academics were the investigators of a placebo-controlled trial on the use of statins for primary prevention of cardiovascular disease (CVD) in populations with hypercholesterolaemia but at low risk of CVD. Enrolment for the trial was slow at the beginning but improves rapidly. Subjects were randomised in multicentre sites in Israel, Spain, Italy and France. Suddenly, out of the blue, the sponsor decided to stop the trial. There were no safety, efficacy or feasibility issues to support such a decision. The reason behind it was a strategic one. Global marketing strategies prevailed. The authors went on to outline some suggestions for better practice, such as the inclusion of patient representatives on steering committees and the presence of independent bodies in such decisional committees.

Dr Madhu Davies expresses her opinion as a physician working in the pharmaceutical industry. She makes the case that there are two sides to every story and, however altruistic a company might be, the sponsors must look at the bottom line: costs and funding. The clinical trial environment is extremely competitive and many drugs never make it onto the market. However, we should not forget that the Declaration of Helsinki puts human rights before financial ones.

ICH GCP compliance in the USA
By Cheri Wilczek and Galen Neher
Abstract
The ICH GCP guidelines were finalised in the July 1996 and were published in the US Federal Register as official FDA guidelines in May 1997. To estimate the current level of compliance with ICH GCP in the USA, we conducted a survey of US companies and US subsidiaries of non-US companies.

Using the Internet as part of a coordinated patient recruitment strategy
By Dan Mcdonald
Abstract
In the past several years, the Internet has gained credibility as a viable patient recruitment resource. Although the incidence of Internet usage to recruit patients is relatively low at this time, clinical research professionals - in sponsor and CRO companies as well as in investigative sites � have begun to see dramatic increases in usage.

Clinical development of atypical antipsychotics
By Prof Dr Klaudius Siegfried
Abstract
The review of essential features of both regulatory requirements and the practice of clinic studies with newer antipsychotics drugs has demonstrated that, in spite of potential scientific , methodological, and ethical concerns, regulatory requirements can be met and studies oriented at current FDA and CPMP guidelines are feasible.

Why should you work under a US IND outside the USA
By Debra Baker and Genevieve Decoster
Abstract
The aim of this article is to outline the process of working under a US IND within and outside the USA and discuss two common problems in global development programmes. These are the acceptability of foreign data for US regulatory submissions and whether it is necessary to generate this data, under a US IND or if there are other acceptable alternatives.

Validation of e-clinical trials systems
By Rob King and Dr Michael Bowden
Abstract
Open any industry publication and a glance at the myriad of advertisements promoting e-trial software confirms that we are in the midst of a revolution in the availability of software solutions for data capture and clinical data management tailored specifically to our industry.