Good Clinical Practice Journal

Below are the titles of articles published in the Good Clinical Practice Journal Volume 6 Issue 6 (November/December 1999).

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

"Globalising the achievements of the ICH process: where do we go from here?"
by Dr Elaine Esber

Abstract
The ICH achievements in harmonising clinical trial design and regulatory practices are evaluated in the global research environment. A new ICH working group was formed to extend cooperation to non-ICH regions. The future agenda needs to be developed in close cooperation with WHO and ICDRA.

"Past and future contributions of resource-poor countries to clinical research"
by Professor Natth Bhamarapravati

Abstract
Differences between nations in the level of development of their biomedical research capacity need to be addressed through government policy, international fora, and education. All those involved in international research today have an interest in setting high standards and in ensuring that these standards are adhered to everywhere in the world. Partnerships need to be developed in international biomedical research that ensure that resource-poor countries, not only benefit from their participation in research projects, but that these countries also contribute to our understanding of health and disease.

"Globalising guiding principles for clinical trials: Good Clinical Practice beyond the European Union, the United States, and Japan"
by Professor Juhanna E. Idänpään-Heikkilä

Abstract
Two organisations have worked hard to develop guidelines that address clinical research on an international scale. The WHO and ICH initiatives differ in important respects regarding their objectives. However, both have achieved their goals, to some extent. Further achievements in the globalisation of guiding principles will require concerted actions by these two leading organisations.

"The expectations of resource-poor countries in clinical research"
by Professor Hoosen M. Coovadia

Abstract
Despite the limitations of infrastructure and finance faced by researchers in resource-poor countries, researchers in these settings are increasingly contributing to the global understanding of disease and health. This research needs to be further stimulated and appreciated. At the same time, there is a need to guard against the importation of research from developed countries that does not contribute to the health needs of the populations on which it is being carried out.

"How the Declaration of Helsinki developed"
by Sev Fluss

Abstract
The adoption in 1964 of the Declaration of Helsinki was the culmination of developments prior to and following World War II. The major events that led to the development of the so-called Helsinki I need to be appreciated in the context of the research interests during the 1940's, the 1950's, and the early 1960's. The author traces the response to the Nuremberg Trials from the first meeting of the World Medical Association in 1947 to the subsequent Resolution on Human Experimentation in 1954, and the first draft of Helsinki in 1962. The aim of this article is to provide us with an appreciation of the background to our fundamental guiding principles for biomedical research at the end of this Century.

"A debate on international research ethics: the role of the World Medical Association"
Rachel Babbedge interviews Dr Delon Human

Abstract
The Declaration of Helsinki is currently the focal point for much of the debate on international research ethics. In this interview, the Secretary General of the World Medical Association (WMA) describes how this debate is being approached. The role of the WMA on the world research stage is discussed.

"An international dialogue in research ethics: the experience of the Council of Europe"
by Péteris Zilgalvis

Abstract
The role of the Convention on Human Rights and Biomedicine in the debate on biomedical research and ethics in Europe is explained here by one of the persons closest to the entire process. This Convention provides a legal framework for biomedical research and ethics in Europe. It has also provided a general context for developing relationships between Western European countries and Central and Eastern European countries. The work continues with the ongoing development of additional protocols and the DEBRA Programme.

"Establishing African guidelines for biomedical research in a framework of high ethical standards"
by Dr Pierre Effa

Abstract
The gap in African scientific and technological development today is reflected both in the level of biomedical research and the level of health offered to its citizens. There is a need to address this gap through a structured programme that builds on the commitments already made to biomedical research in Africa. Guidelines for research in Africa need to be developed; however, such guidelines will also need a system for implementation.

"Establishing standards for HIV vaccine trials: a process of international dialogue"
by Jose Esparza, Claire Pattou and Saladin Osmanov

Abstract
HIV/AIDS has raised a number of important scientific questions with regard to clinical trials carried out in developing countries. A broad consultation process was carried out by UNAIDS aimed at the development of local capacity and international guidance for HIV vaccine trials. This consultation process has been launched in advance of the major thrust in clinical trials in this area in order to assist researchers and communities in addressing the basic questions of international collaborative research.