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Clinical trials of antibacterial agents: a practical guide to design and analysis. Statisticians in the Pharmaceutical Industry Working Party
- Source :
- Journal of Antimicrobial Chemotherapy. 41:467-480
- Publication Year :
- 1998
- Publisher :
- Oxford University Press (OUP), 1998.
-
Abstract
- Guidelines on the conduct of clinical trials of antibacterial agents produced by the US Food and Drug Administration, the British Society for Antimicrobial Chemotherapy, the Infectious Diseases Society of America and a European Working Party have been reviewed. Although very informative, these guidelines provide limited practical guidance on the design and statistical aspects of phase III studies of antimicrobial agents. This paper describes the differences between antibacterial trials and clinical studies in other therapeutic areas with regard to subjective endpoints, dual clinical and bacteriological endpoints, frequent protocol violations and difficulty of using placebo controls. The importance of a detailed protocol and planned analysis strategy is emphasized. The choice of comparator agents, practical issues with the blinding of trial materials and the documentation of patients excluded from study entry are discussed. The use of different patient groups and different endpoints in analyses are described. The principles of equivalence and their application to trials of antibacterial agents are discussed, together with an approach to calculating sample size. A variety of statistical analyses of results are compared for different situations indicating some of the problems that can arise. Different methods of presentation of study data are included with emphasis on regulatory submissions rather than scientific publications. Some graphical presentations are recommended and issues regarding data across different studies are discussed.
- Subjects :
- Microbiology (medical)
Research design
medicine.medical_specialty
Blinding
MEDLINE
Pharmacology
Documentation
Anti-Infective Agents
Clinical Protocols
Humans
Multicenter Studies as Topic
Medicine
Pharmacology (medical)
Medical physics
Selection Bias
Randomized Controlled Trials as Topic
Antibacterial agent
Pharmaceutical industry
Protocol (science)
business.industry
Patient Selection
Bacterial Infections
Clinical trial
Treatment Outcome
Infectious Diseases
Clinical Trials, Phase III as Topic
Research Design
Data Interpretation, Statistical
business
Subjects
Details
- ISSN :
- 14602091
- Volume :
- 41
- Database :
- OpenAIRE
- Journal :
- Journal of Antimicrobial Chemotherapy
- Accession number :
- edsair.doi.dedup.....bd8d5499d8567276dd4f415eec8525fb
- Full Text :
- https://doi.org/10.1093/jac/41.4.467