Ensuring Good Statistical Practice in Clinical Research: Guidelines for Standard Operating Procedures (An Update)
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0092-8615198 Copyright Q 1998 Drug Information Association Inc.
ENSURING GOOD STATISTICAL PRACTICE IN CLINICAL RESEARCH: GUIDELINES FOR STANDARD OPERATING PROCEDURES (AN UPDATE) PHILIP M. NORTH ASRU LTD, Swalecliffe, United Kingdom, on behalf of the Statisticians in the Pharmaceutical Industry Public Affairs Sub-Committee
In 1994, the Statisticians in the Pharmaceutical Industry published Guidelines for Standard Operating Procedures (GSOPs) on good statistical practice in clinical research. Background and rationale for the GSOPs and the latest release of these guidelines (August 1997) are included in this paper. Users of the GSOPs have found them to be useful when developing company standard operating procedures. The GSOPs help ensure a professional approach, adherence to good statistical practice, and compliance with regulatory requirements. GSOPs are always developing and evolving. Key Words: Statisticians in the Pharmaceutical Industry; Good statistical practice in clinical research; Guidelines for standard operating procedures
INTRODUCTION STATISTICIANS IN THE Pharmaceutical Industry (PSI) is a professional organization fonned in 1977 with the following objectives: 1. To promote professional standards of statistics in matters pertinent to the phannaceutical industry, and 2. To provide a forum for regular discussion on statistics and matters relating to the practice of statistics in the pharmaceutical industry. PSI currently has approximately 900 members, mainly in the pharmaceutical industry,
Reprint address: Philip M. North. PSI Executive Secretary, P.O. Box 126, Macclesfield, Cheshire, SK1 8FH.
including contract research organizations (CROs). Most (over 80%) members are based in the United Kingdom. The need for detailed guidance on good statistical practice in clinical research has developed as the involvement of statisticians in the conduct and reporting of clinical trials has increased, and the requirements of the regulatory authorities responsible for the approval of new drugs have become more stringent. In response to this growing need for guidance the PSI Professional Standards Working Party was set up in May 1980 and developed a set of 11 guidelines for standard operating procedures (GSOPs) over an 18month period. These GSOPs were described and reproduced in full by the PSI Professional Standards Working Party (1994). Clearly, in developing the GSOPs there was a need to ensure consistency with guidelines such as those developed by the International Conference on Harmonisation (ICH).
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Philip M.North and the PSI Public Aflairs Sub-committee
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The objectives of PSI in the development of the GSOPs were stated by the PSI Professional Standards Working Party (1994) to be:
To ensure that statisticians in the pharmaceutical industry are aware of the principles of good statistical practice, 0 To encourage adherence to these principles in the application of statistics to clinical trials, 0 To enc,ouragethe principles of good statisti
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