Contemporary clinical trials
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Contemp Clin Trials · Sep 2010
Estimating adjusted NNTs in randomised controlled trials with binary outcomes: a simulation study.
The number needed to treat (NNT) is a popular measure to describe the absolute effect of a new treatment compared with a standard treatment or placebo in randomised controlled trials (RCTs) with binary outcome. For applications in epidemiology, the average risk difference (ARD) approach based upon logistic regression was proposed to estimate NNT measures with adjustment for covariates. In the context of cohort studies, averaging is performed separately over the unexposed and the exposed persons to account for possible different exposure effects in the two groups or over the entire sample. ⋯ By means of simulations we show that the estimation of risk differences and NNTs with adjustment for balanced covariates leads to a gain in precision. A considerable gain in precision is obtained in the case of strong covariate predictors with large variance. Therefore, it is preferable to adjust for balanced covariates in RCTs when the treatment effect is expressed in terms of risk differences and NNTs and the covariate represents a strong predictor.
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A Contract Research Organization (CRO) is a service organization that provides support to the pharmaceutical industry and offers a wide range of "outsourced" pharmaceutical research services to aid in R&D process and is thus an essential tool for undertaking clinical trials in the present scenario when high stakes are involved in the drug discovery process. This industry also offers a safe option of investment as the industry is largely recession-proof, with a significant upscale growth. Presently India occupies a very small pie of the global market share in the Clinical Trials Industry but it is estimated to conduct nearly 5% of global clinical trials by 2012. ⋯ According to a recent study by Mckinsey & Company, the Indian Clinical Research Industry can attract $1.5 bn of revenue from US and EU by 2010. Such an increase in outsourcing from the western countries has led the global pharma companies and Indian entrepreneurs to set up Contract Research Organizations (CROs) in India. To bring this into realization and fulfil the market demand, while simultaneously aiding in improving the country's economical standards and market position, joint and well-coordinated efforts on part of the government, industry, and working professionals are needed in terms of regulatory affairs, audits, transparency in work affairs, garnering patient confidence, and pharmacovigilance.
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Contemp Clin Trials · Sep 2010
Comparative StudySingle momentary assessments are not reliable outcomes for clinical trials.
Patient reported outcomes (PROs) play an essential role in clinical trials, though questions have been raised about the accuracy of PROs using long recall periods. This paper examines the utility of a PRO employing a single momentary assessment of pain in a sample of community rheumatology patients. We explore the accuracy and reliability of a single assessment versus the average of multiple assessments taken over 1-week, which is considered a common outcome reporting period. ⋯ Longitudinal analysis of change scores across 3 months also demonstrated considerable unreliability of single-point measures, thus the statistical power generated by single-point assessments was considerably less than the more reliable week average. Our conclusion is that single momentary assessments, at least for representing an outcome over a period of a week, are not ideal measures. We discuss alternative measurement strategies for efficiently collecting PRO data for a 1-week period using end-of-day diaries or 7-day recall measures.
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Contemp Clin Trials · Sep 2010
Development and implementation of a performance measure tool in an academic pediatric research network.
The Pediatric Emergency Care Applied Research Network (PECARN) is a federally funded multi-center research network. To promote high quality research within the network, it is important to establish evaluation tools to measure performance of the research sites. ⋯ Report cards have helped PECARN sites and investigators focus on performance improvement and may have contributed to improved operations and efficiencies within the network.