| Use of a medication control officer to reduce bias in a clinical trial: lessons learned from the scleroderma lung study. | |
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MedLine Citation:
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PMID: 20032002 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: Scleroderma Lung Study (SLS) was designed to evaluate the efficacy and safety of oral cyclophosphamide (CYC) versus placebo taken for 1 year for scleroderma-associated interstitial lung disease. An independent medication control officer (MCO), usually a physician, at each center was assigned to monitor laboratory and clinical toxicity of study medication and regulate its dosing based on these results. By having an MCO who watched and managed toxicity, the study investigators were free to care for study patients and to assess study outcomes without the potential bias of knowing toxicity data (toxicity from cyclophosphamide is distinctive - cytopenias and hematuria in particular). PURPOSE: To assess the usefulness of an MCO, whose chief role was to maintain safety while retaining the blinding in the clinical trial. METHODS: Patients had safety laboratory testing every 2-4 weeks and results were sent directly to the MCO within 2 days of the test. Other clinical adverse events (AEs) were reported by the patient to a nurse coordinator who reported them to the MCO who then managed the AEs to preserve the blinding of investigators caring for the patients. The MCO was provided pre-determined algorithms for dose adjustments of test medication based on the presence and severity of laboratory abnormalities. RESULTS: Safety monitoring by the MCO was effective in the early detection of drug toxicity with provision of appropriate medical intervention on a timely basis. At the same time, investigator blinding appeared to be maintained. LIMITATIONS: The testing of MCO effectiveness in maintaining blinding and consistency was not defined as an a priori hypothesis and thus complete data relating to the efficacy of the MCO were not collected in a prospective fashion. CONCLUSION: An MCO and pre-specified monitoring and dosing guidelines, coupled with uniform pre-specified responses to AEs, may be used effectively to preserve investigator blinding and provide consistency in response to AEs in a clinical trial setting, even when AEs of the test medication are distinctive. |
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Authors:
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Vivien M Hsu; Dinesh Khanna; Edwin Smith; Tan Filemon; Sean Whelton; Mel Lopata; John C Davis; Albert Polito; Louis Heck; Jerry Molitor; Micha Abeles; Jose Granda; Joseph Korn; Philip Clements; |
Publication Detail:
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Type: Journal Article; Research Support, N.I.H., Extramural Date: 2009-12-23 |
Journal Detail:
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Title: Clinical trials (London, England) Volume: 7 ISSN: 1740-7753 ISO Abbreviation: Clin Trials Publication Date: 2010 Feb |
Date Detail:
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Created Date: 2010-02-16 Completed Date: 2010-05-20 Revised Date: 2010-09-29 |
Medline Journal Info:
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Nlm Unique ID: 101197451 Medline TA: Clin Trials Country: England |
Other Details:
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Languages: eng Pagination: 85-9 Citation Subset: IM |
Affiliation:
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Division of Rheumatology, UMDNJ Scleroderma Program, New Brunswick, NJ 08903, USA. hsuvm@umdnj.edu |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Bias (Epidemiology)* Clinical Protocols Cyclophosphamide / administration & dosage, therapeutic use Humans Immunosuppressive Agents / administration & dosage, therapeutic use Lung Diseases / drug therapy* Medication Therapy Management / organization & administration* Multicenter Studies as Topic Randomized Controlled Trials as Topic / standards Research Personnel* Scleroderma, Localized / drug therapy* |
| Grant Support | |
ID/Acronym/Agency:
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K23 AR053858-03/AR/NIAMS NIH HHS; UO1 HL 60606/HL/NHLBI NIH HHS; UO1 HL60587/HL/NHLBI NIH HHS |
| Chemical | |
Reg. No./Substance:
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0/Immunosuppressive Agents; 50-18-0/Cyclophosphamide |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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