Good Clinical Practice Journal

Below are the titles of articles published in the Good Clinical Practice Journal Volume 6 Issue 1 (January/February 1999).

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

"Obtaining approval for clinical trials in Latin America"
by Dr Richard Taylor

Abstract
The regulatory climate in Latin America is conducive to international clinical development programmes. The regulatory requirements and clinical trial procedures are discussed in detail, focusing on Argentina, Brazil and Mexico. Also listed are the various reporting/documentation requirements and special considerations, and a comparison between regulations in the three countries.

"Inspections of clinical trials in Spain"
by Dr Inés Galende and José Antonio Sacristán

Abstract
Guidelines for Good Clinical Practice have been in place in Europe since 1990, but in Spain there is no national requirement for inspections of clinical trials. Only two regions in Spain have introduced comprehensive inspections. The inspection procedure in the autonomous Community of Madrid is described here in detail. Three groups were inspected: the independent ethics committees, the investigator team, and the sponsor. The objectives and criteria for each stage of the inspections are outlined.

"Informed consent in healthy volunteers: whom does it protect?"
by Dr AA Van Vliet, Dr J Wemer, Dr B Wilffert, JWP De Vroedt LL.M, MHA and Professor JHG Jonkman

Abstract
In the next decade, centres for research on the safety, tolerability or bioequivalence of new molecular entities will be confronted with numerous compounds, a narrowing time frame for performing Phase I research activities, and a growing demand for healthy volunteers for participation in non-therapeutic drug studies. A written informed consent (WIC), although required by law for medical investigators, appears to be similar to a contract, but strictly speaking it is not. A WIC is a unilateral statement by a healthy volunteer declaring to take on a number of obligations and to have understood that he has certain rights. The volunteer must accept or reject the statement as a whole because no individual alterations are allowed. Despite this, it is felt that the WIC assists in maintaining a balance between non-exploitation and the struggle for profit by avoiding unrealistic expectations on both sides.

"How to select a GCP compliant central laboratory"
by Dr Susan Makkink

Abstract
Compliance of a central laboratory with GCP and other regulatory requirements includes accurate analytical tests, reporting, interpretation and verification of all clinical laboratory data. The central laboratory must have detailed written Standard Operating Procedures (SOPs), validated analytical tests, calibrated and back-up equipment, and adequate facilities. The laboratory personnel involved in clinical trials must be qualified by education, training and experience. They should be aware of the GCP requirements and the details of the trial. The central laboratory should have effective internal and external quality control procedures, and should be experienced in drug research.

"What is the potential of the Internet for clinical research?"
by Dr Laura Brown

Abstract
The origins of the Internet are traced, and different electronic networks are explained. Various uses for the Internet by the pharmaceutical industry are suggested, with useful website addresses and search methods. Identification of investigators and recruitment of patients also occur via the Internet. There are websites focusing on chronic illnesses which can be a good source of patients. Electronic study management and data capture is also feasible, however ensuring the security of patient data remains a concern.

"How will changes in GCP regulations affect non-profit organisations conducting academic clinical research?"
by Dr Denis Lacombe

Abstract
Academic research is aimed at evaluating diagnostic and therapeutic strategies, while pharmaceutical research is directed exclusively at the development of medicinal products. The regulations currently in place do not fully take into account the needs of the academic community. Both types of research must apply and enforce the principles of GCP; however, the safety and efficacy of drugs used in academic research have already been proven. There is an urgent need for harmonisation of the practical procedures taking the full needs of all partners into account.