Using Model-based Meta-analysis to Improve Decision-making in Drug Development

Making the right choices in drug development often means the difference between getting a new medication to patients and it ending up in the scrap heap of failed programs. There is a surfeit of publicly available information on approved drugs as well as those currently in development. How can sponsors turn clinical trial data into understanding that helps chart the course for investigational drugs?

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ST analysis of the fetal electrocardiogram in intrapartum fetal monitoring: a meta-analysis

The objective of this study was to compare the effects of ST-waveform analysis in combination with cardiotocography with conventional cardiotocography for intrapartum fetal monitoring. We searched MEDLINE, Embase, and PubMed for randomized controlled trials (RCTs) evaluating ST-waveform analysis for intrapartum fetal monitoring. We identified RCTs that compared ST-waveform analysis and conventional cardiotocography for intrapartum fetal […]

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A systematic comparison of software dedicated to meta-analysis of causal studies

Our objective was to systematically assess the differences in features, results, and usability of currently available meta-analysis programs. We did an extensive search on the internet (Google, Yahoo, Altavista, and MSN) for specialized meta-analysis software. We included six programs in our review: Comprehensive Meta-analysis (CMA), MetAnalysis, MetaWin, MIX, RevMan, and WEasyMA. Two investigators compared the […]

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Meta-analysis of the diagnostic accuracy of transesophageal echocardiography for assessment of atherosclerosis in the ascending aorta in patients undergoing cardiac surgery

Stroke after cardiac surgery may be caused by emboli emerging from an atherosclerotic ascending aorta (AA). Epiaortic ultrasound scanning (EUS), the current ‘gold’ standard for detecting AA atherosclerosis, has not gained widespread use because there is a lack of optimized ultrasound devices, it lengthens the procedure, it endangers sterility, and there is a false belief […]

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Detection of lymph node metastases by gadolinium-enhanced magnetic resonance imaging: systematic review and meta-analysis

Gadolinium-based contrast agents are used with magnetic resonance imaging (MRI) to highlight tumor vascularity in organs. They are also widely used for primary tumor visualization. We conducted a systematic review and meta-analysis of the existing evidence of the accuracy of gadolinium-enhanced MRI for staging lymph node metastases. We systematically searched the MEDLINE, Cochrane, CANCERLIT, and […]

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Meta-analysis of thoracic epidural anesthesia versus general anesthesia for cardiac surgery

A combination of general anesthesia (GA) with thoracic epidural anesthesia (TEA) may have a beneficial effect on clinical outcomes after cardiac surgery. We have performed a meta-analysis to compare mortality and cardiac, respiratory, and neurologic complications in patients undergoing cardiac surgery with GA alone or a combination of GA with TEA. Randomized studies comparing outcomes […]

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Systematic review: diagnostic accuracy of clinical decision rules for venous thromboembolism in elderly

Physicians committed to the care of elderly patients are challenged with the diagnosis of venous thromboembolism (VTE: deep venous thrombosis and pulmonary embolism) due to a higher incidence, co-morbidities masking signs and symptoms and burdening referrals. Clinical decision rules (CDRs) have been developed and implemented for VTE. Yet, until now, no study has evaluated the […]

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Excluding venous thromboembolism using point of care D-dimer tests in outpatients: a diagnostic meta-analysis

This article is a review the evidence on the diagnostic accuracy of the currently available point of care D-dimer tests for excluding venous thromboembolism. We conducted a systematic review of research on the accuracy of point of care D-dimer tests, using bivariate regression to examine sources of variation and to estimate sensitivity and specificity. Studies […]

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Does neuromuscular electrical stimulation strengthen the quadriceps femoris? A systematic review of randomised controlled trials

Devices for neuromuscular electrical stimulation (NMES) are increasingly used by individuals without specific injuries and are standard equipment in most physical therapy practices. The most often stimulated muscle group is the quadriceps femoris. We designed a systematic review and meta-analysis of randomized controlled trials to determine whether NMES is an effective modality for strength augmentation […]

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Under-reporting of venous and arterial thrombotic events in randomized clinical trials: a meta-analysis

For the detection of unwanted outcomes of new interventions, physicians rely on adverse event reporting. We attempt to quantify the reported incidence of venous thromboembolism (VTE) and arterial thrombosis (AT) in randomized clinical trials (RCTs), and evaluate the extent of under-reporting. We selected all therapeutic RCTs published in the four highest-impact general medicine journals between […]

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Population pharmacokinetic analysis of thrombomodulin alfa to support dosing rationale in patients with renal impairment.

Thrombomodulin alfa is a soluble recombinant human thrombomodulin that was reported to enhance the reversal of disseminated intravascular coagulation (DIC) in subjects with sepsis or hematologic malignancy and reduce mortality in subjects with sepsis and DIC. Population pharmacokinetic (PK) analysis of thrombomodulin alfa was performed based on rich samples collected in 24 healthy subjects (0.02 […]

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Beyond Publication Bias

In drug development, clinical medicine, or health policy making, basing one’s decisions on a selective part of the available evidence can pose a major threat to the health of patients and the society. If, for example, primarily positive research reports are taken into account, one could wrongfully conclude that a harmful drug is safe.

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