Good Clinical Practice Journal

Below are the titles of articles published in the Good Clinical Practice Journal Volume 5 Issue 1 (January/February 1998).

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

"Clinical research in a proliferating jungle of regulations"
by Cecil Nick

Abstract
A proposed EU GCP Directive, now in draft form, will mandate compliance with GMP and GCP. The Directive embraces all interventional studies from Phase I to Phase 4 and will regulate not only GCP but many other aspects of clinical research. GCP inspection will become mandatory, as will release of trial supplies by a Qualified Person and the need for retesting of medicinal products imported from outside the EU. It is hoped that some of these requirements will be tempered when the Directive becomes final as otherwise development costs will soar and clinical research will be driven from the EU.

"Conducting clinical trials in South Africa"
by Matt Haus

Abstract
The new political climate has meant that South Africa is now competing alongside world leaders in clinical trials. In this article, a medical director with many years of medical research expertise, reports on the growth of South Africa's pharmaceutical market.

"Pricing challenges in the pharmaceutical market in Central and Eastern Europe"
by Peter Urban

Abstract
Although there has been a substantial shift in the monetary systems and government policies of CEE nations, the pharmaceutical sector in these countries has remained in many ways unaffected. Controls on prescription, reimbursement and categorization of drugs have limited free pricing and distribution. In order to reach a consensus about what should be done to remove some of the obstacles that are currently in the way of changing this situation, the Warsaw conference was held at the end of last year, bringing together purchasers, suppliers and providers from across CEE countries. Some of their discussions are reported here.

"How changes in the pharmaceutical industry affect the role of CROs"
by Benoît Bouche

Abstract
This article traces the past, present and future path of CROs in the ever-changing climate of the pharmaceutical market from the point of view of a CEO who has over ten year's of experience of running a CRO.

"The role of ISO 9000 in clinical research"
by Alan Eggleston

Abstract
The need for quality within the clinical development process is becoming an absolute. Organisations increasingly need to operate formal systems and have structures in place which maximise their chances of achieving that quality. This article looks at the benefits and short-comings of the International Standards Organisation's 9000 suite of standards as external endorsements of those systems and structures and attempts to define their value and role within the clinical development process. Although no magic wand, ISO 9000, when used appropriately in conjunction with Good Clinical Practice, is a powerful tool which enforces an internal discipline and makes the organisation focus upon systems and processes which are likely to maximise the chances of producing "Useable data, on time, in budget".

"Record retention requirements for CROs and labs"
by Tom Gallacher

Abstract
This paper was prepared as a result of feedback from a survey on records management issues conducted by the Records Management and Archiving Working Party of the European Forum for GCP (EFGCP). One of the problem areas identified by EFGCP members related to responsibilities for filing and archiving when sponsors contract study related activities to CROs and/or laboratories. This article provides recommendations intended to address this issue.

"The regulatory requirements for clinical trials in Central Eastern Europe"
by Lillian Nartoff

Abstract
All Central Eastern European countries (CEE) are currently adjusting their legal framework and consequently the procedures necessary for approval of clinical trials. In countries where this process started earlier, such as Poland, Hungary or Estonia, most of the necessary regulations are already in place; the requirements for approval are similar to those in Western Europe and approval may be obtained within 6-8 weeks. In some of the other CEE countries such as Slovakia and Romania this process is still incomplete. It is important to remain informed of changes in regulations before planning CTs, remembering that in some countries, for example Lithuania, it may take currently as short a time as one month from submitting the application to starting a CT.