| Interpretation of hematological and biochemical laboratory data in large-scale, multicenter clinical trials. | |
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MedLine Citation:
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PMID: 469024 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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The laboratory assessment of drug tolerability is central to a long-term trial. But because of its volume, its multicenter origin, and the importance of nondrug factors, the analysis of these data is complicated. Various methods, i.e., collection of investigators' opinion, comparison of before- and after-treatment means, and analysis of transitions, were found to be unsatisfactory. A fourth method, described in this paper, seems to be more promising. An initial computer screening of the laboratory data is conducted to identify all patients with the potentially clinically relevant laboratory abnormalities. Each laboratory abnormally is then examined by the pharmaceutical physician with regard to the patient's sex and age, the trial diagnosis, concomitant and intercurrent illnesses, concurrent medication, unwanted effects, and other laboratory results, and each result is assigned a probable etiology according to a pre-defined classification system. By this method it is then possible to compare the frequency and severity of possible or probable drug-related laboratory abnormalities occurring with the various trial drugs. Our opinion regarding the importance of using this method would appear justified by the fact that a possible or probable drug effect was considered to have been responsible for only 15 per cent (112/760) of the potentially clinically relevant abnormal tests reported. |
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Authors:
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S N Ciccolunghi; P D Fowler; M J Chaudri |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Journal of clinical pharmacology Volume: 19 ISSN: 0091-2700 ISO Abbreviation: J Clin Pharmacol Publication Date: 1979 May-Jun |
Date Detail:
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Created Date: 1979-10-17 Completed Date: 1979-10-17 Revised Date: 2004-11-17 |
Medline Journal Info:
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Nlm Unique ID: 0366372 Medline TA: J Clin Pharmacol Country: UNITED STATES |
Other Details:
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Languages: eng Pagination: 303-12 Citation Subset: IM |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Blood Cell Count Blood Chemical Analysis Drug Evaluation* Hematologic Diseases / chemically induced* Hematologic Tests* Humans Laboratories Liver Function Tests Metabolism / drug effects* Research Design Urine / analysis |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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