Good Clinical Practice Journal

Below are the titles of articles published in the Good Clinical Practice Journal Volume 5 Issue 2 (March/April 1998).

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"Implementation of ICH GCP"
by Laura Brown

Abstract
There has been some confusion in Europe as to what is the final version of the ICH GCP guideline. The Japanese have updated their own GCP guidelines and are implementing the ICH GCP requirements in stages. The version of the guideline published in the USA by the FDA in the Federal Register differs from the finalised version produced at Step 4 of the ICH process.

"Removing the barriers to performing clinical trials in academic Settings"
by Rita M. Pelusio and Barbara E. Herr

Abstract
The clinical research phase of product development involves the collection of accurate, quality data, delivered on schedule to meet project milestones and fully support product registration. Clinical investigators in academic medical centers (AMCs) are valuable resources for contributing to study design and performing controlled clinical trials. Both industrial sponsors and AMCs are under increasing pressures to control costs, increase revenue, and meet deadlines on time. This paper proposes that the goals of industry and of AMCs could be synergistic and indicates where, through the efforts of both parties, the barriers perceived to interfere with performing clinical trials in AMCs might be eliminated.

"Towards a perfect clinical submission Part 1: the clinical development plan and Phase I trials"
by Cecil Nick

Abstract
CPMP and ICH clinical guidelines are key information sources. These are reviewed alongside practical considerations for successful clinical research. Regulatory approval requires meticulous planning starting with a clinical plan and progressing systematically through phases I to III. This, the first, in a series of three articles looks at issues relating to the clinical plan and Phase I studies.

"Critical issues of local and centralized clinical trials from an investigator's perspective"
by Michael B. Dabrow

Abstract
Only by conducting well designed, scientifically sound clinical trials will new therapies for existing and emerging diseases be rationally advanced to become standard practice. We must increase the accrual of patients into these studies if new therapies are to be introduced in a timely manner. Studies must have clear, attainable goals that can easily be explained to patients and their families. Experience in specific laboratory techniques, quality data management and interpretation skills are essential for the conduct of clinical laboratory trials.

"Danish Society of Good Clinical Practice: Alive for a decade and looking forward to the next"
by Ebbe Englev and Kurt Pfeiffer Peterson

Abstract
The Danish Society of Good Clinical Practice recently celebrated its 10 year anniversary. The Society is unique in providing a forum where all parties involved in clinical trials can meet, discuss and develop GCP. Three individuals, who have made significant contributions to the understanding and development of GCP, received the 1997 GCP prize.

"Clinical studies in asthma"
by Trevor T. Hansel, Margaret J. Leckie, Jamey Khan and Peter J. Barnes

Abstract
The global increase in asthma is alarming, and highlights the need for development of new and more specific treatments. This article considers clinical studies with four types of drug for asthma: bronchodilators, anti-inflammatory agents, treatments for emergency asthma, and disease-modifying therapy. It is important to make sound decisions in phase I/II proof of concept studies, before embarking on large-scale and expensive phase III studies. In this context, there is the need to identify new clinical study designs and identify improved surrogate markers for the monitoring of inflammation.