Good Clinical Practice Journal

Below are the titles of articles published in the Good Clinical Practice Journal Volume 6 Issue 4 (July/August 1999).

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

"Improving patient recruitment"
by Dr Ian Dews

Abstract
There are no magic tricks which guarantee problem-free recruitment. Success comes from the care given to every stage of the development process from initial planning through protocol writing, centre selection and initiation to monitoring. Valuable recruitment time may be saved by careful planning and efficient set-up, while patient-friendly procedures in the hands of motivated clinicians will maximise the use of that time. Tired gimmicks merely disillusion investigators, while excess pressure carries the risk of encouraging fraud. The key is to build working partnerships between disciplines within the sponsor company, between sponsor and investigator and between investigator and patient.

"Reconciliation of issued, used and unused CRF books, modules and pages"
by Susan Vaillant

Abstract
The conclusions of the EFGCP Working Party on Records Management and Archiving are presented. A standardised procedure for documenting and reconciling the pages in a case report form are outlined. Template forms, both blank and with sample data, are provided to be adapted for use as templates. The importance of consecutive page numbering is stressed, as is the maintenance of adequate documentation. Key activities in ensuring the completeness of the Trial Master File are defined.

"The future of CROs in drug development - a personal view"
by Dr Graham Hughes

Abstract
The rate of growth of CROs and CPMs has been in constant decline since 1990. Strategic alliances between pharmaceutical companies and major CROs dominate the marketplace. CROs are essentially perceived as commodity suppliers, and new CROs must offer specialised, niche services. The alliances between pharma companies and CROs differ in many respects from strategic alliances in other industries. Pressures on the pharma industry include generic competition, increasing regulation, lack of methodological innovation and escalating R&D costs.

"FDA GCP - a practical approach"
by Dr Galen Neher

Abstract
The Federal Agency of the US Food and Drug Administration (FDA) established US GCP over a number of years in response to inspection findings that cast doubt on the validity of some clinical trials. Because they were instituted over time, the US GCP regulations (FDA GCP) are not a single document, being located in various sections of Chapter 21 of the Code of Federal Regulations. Despite the fact that ICH GCP is now the most accepted GCP standard throughout the world, and has been published as a guideline in the Federal Register as an official FDA guideline, it is only a guideline and so investigators, nurses, ethical review boards and monitors all need to have complied with FDA GCP regulations when the inspector comes to call.

"Facing the challenges of clinical trials in cancer"
Fiona Jones interviews Dr Philippe Genne

Abstract
Fiona Jones interviews Dr Philippe Genne, President of ONCODESIGN. Cancer is a multi-parameter phenomenon and is elusive target in terms of drug therapy. Major challenges include overcoming multi-drug resistence and the ethical inappropriateness of conducting Phase I clinical trials. The development of experimental rodent models to test novel anticancer agents is a possible solution. Funding is also a limiting factor, with an upsurge of research being located in Eastern Europe. Finally Dr Genne discusses his vision for the future in terms of gene therapy and other advances in biotechnology.