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      Clinical Trials: Minimising source data queries to streamline endpoint adjudication in a large multi-national trial

      , 1 , 2 , 3 , 1

      Trials

      BioMed Central

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          Abstract

          Background

          The UK Clinical Trial Regulations and Good Clinical Practice guidelines specify that the study sponsor must ensure clinical trial data are accurately reported, recorded and verified to ensure patient safety and scientific integrity. The methods that are utilised to assess data quality and the results of any reviews undertaken are rarely reported in the literature. We have recently undertaken a quality review of trial data submitted to a Clinical Endpoint Committee for adjudication. The purpose of the review was to identify areas that could be improved for future clinical trials. The results are reported in this paper.

          Methods

          Throughout the course of the study, all data queries were logged. Following study close out, queries were coded and categorised. A descriptive and comparative analysis was conducted to determine the frequency of occurrence for each category by country of origin.

          Results

          From 1595 endpoint packages reviewed, 782 queries were generated. No source data queries were generated for countries with ≤ 25 recruited subjects, but both low recruiting and high recruiting countries had a high number of queries relating to subject identifiers.

          Conclusions

          The implementation of some simple measures could help improve data quality and lead to significant savings.

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          Most cited references 2

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          Rosuvastatin and cardiovascular events in patients undergoing hemodialysis.

          Statins reduce the incidence of cardiovascular events in patients at high cardiovascular risk. However, a benefit of statins in such patients who are undergoing hemodialysis has not been proved. We conducted an international, multicenter, randomized, double-blind, prospective trial involving 2776 patients, 50 to 80 years of age, who were undergoing maintenance hemodialysis. We randomly assigned patients to receive rosuvastatin, 10 mg daily, or placebo. The combined primary end point was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. Secondary end points included death from all causes and individual cardiac and vascular events. After 3 months, the mean reduction in low-density lipoprotein (LDL) cholesterol levels was 43% in patients receiving rosuvastatin, from a mean baseline level of 100 mg per deciliter (2.6 mmol per liter). During a median follow-up period of 3.8 years, 396 patients in the rosuvastatin group and 408 patients in the placebo group reached the primary end point (9.2 and 9.5 events per 100 patient-years, respectively; hazard ratio for the combined end point in the rosuvastatin group vs. the placebo group, 0.96; 95% confidence interval [CI], 0.84 to 1.11; P=0.59). Rosuvastatin had no effect on individual components of the primary end point. There was also no significant effect on all-cause mortality (13.5 vs. 14.0 events per 100 patient-years; hazard ratio, 0.96; 95% CI, 0.86 to 1.07; P=0.51). In patients undergoing hemodialysis, the initiation of treatment with rosuvastatin lowered the LDL cholesterol level but had no significant effect on the composite primary end point of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. (ClinicalTrials.gov number, NCT00240331.) 2009 Massachusetts Medical Society
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            Rosuvastatin and cardiovascular events in patients undergoing hemodialysis.

            (2009)
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              Author and article information

              Journal
              Trials
              Trials
              BioMed Central
              1745-6215
              2011
              6 May 2011
              : 12
              : 112
              Affiliations
              [1 ]Glasgow Clinical Research Facility, Tennent Building, Western Infirmary, Glasgow, UK
              [2 ]NHS Greater Glasgow & Clyde Pharmacovigilance Office, Robertson Centre for Biostatistics, Boyd Orr Building, Glasgow, UK
              [3 ]Scottish Stroke Research Network, Walton Building, Glasgow Royal Infirmary, Glasgow, UK
              Article
              1745-6215-12-112
              10.1186/1745-6215-12-112
              3115878
              21548932
              Copyright ©2011 Tolmie et al; licensee BioMed Central Ltd.

              This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

              Categories
              Research

              Medicine

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