Clinical Engagement Network

Incorporating adverse event relatedness into dose-finding clinical trial designs

Incorporating adverse event relatedness into dose-finding clinical trial designs

Wiley:  10/7/13 Dose-finding designs estimate the dose level of a drug based on observed adverse events. Relatedness of the adverse event to the drug has been generally ignored in all proposed design methodologies. These designs assume that the adverse events observed during a trial are definitely related to the drug, which can lead to flawed […]

 Clinical Engagement Network

Network meta-analysis of randomized clinical trials: Reporting the proper summaries

Network meta-analysis of randomized clinical trials: Reporting the proper summaries

Clin Trial: October 3, 2013 Background In the absence of sufficient data directly comparing multiple treatments, indirect comparisons using network meta-analyses (NMAs) can provide useful information. Under current contrast-based (CB) methods for binary outcomes, the patient-centered measures including the treatment-specific event rates and risk differences (RDs) are not provided, which may create some unnecessary obstacles for patients […]

 Clinical Engagement Network

Do Baseline P-Values Follow a Uniform Distribution in Randomised Trials?

Do Baseline P-Values Follow a Uniform Distribution in Randomised Trials?

PLOS:  10/1/13 Background The theory has been put forward that if a null hypothesis is true, P-values should follow a Uniform distribution. This can be used to check the validity of randomisation. Method The theory was tested by simulation for two sample t tests for data from a Normal distribution and a Lognormal distribution, for […]

 Clinical Engagement Network

Performance of two-stage continual reassessment method relative to an optimal benchmark

Clin Trials: October 1, 2013 Background The two-stage, likelihood-based continual reassessment method (CRM-L) entails the specification of a set of design parameters prior to the beginning of its use in a study. The impression of clinicians is that the success of model-based designs, such as CRM-L, depends upon some of the choices made with regard to these […]

 Clinical Engagement Network

Assessing regression to the mean effects in health care initiatives

BMC: September 28, 2013 Background Interventions targeting individuals classified as “high-risk” have become common-place in health care. High-risk may represent outlier values on utilization, cost, or clinical measures. Typically, such individuals are invited to participate in an intervention intended to reduce their level of risk, and after a period of time, a follow-up measurement is […]

 Clinical Engagement Network

Power calculation for overall hypothesis testing with high-dimensional commensurate outcomes

Power calculation for overall hypothesis testing with high-dimensional commensurate outcomes

Wiley: SEP 30, 2013 he complexity of system biology means that any metabolic, genetic, or proteomic pathway typically includes so many components (e.g., molecules) that statistical methods specialized for overall testing of high-dimensional and commensurate outcomes are required. While many overall tests have been proposed, very few have power and sample size methods. We develop accurate […]

 Clinical Engagement Network

Patient-Reported Outcome Alerts Ethical and Logistical Considerations in Clinical Trials

Patient-Reported Outcome Alerts Ethical and Logistical Considerations in Clinical Trials

JAMA: September 25, 2013 The assessment of patient-reported outcomes (PROs) in clinical trials poses a number of potential problems. What happens when a patient reports a severe symptom and no one is monitoring that information; for example, when questionnaires are not reviewed until the end of a study? Do hospitals or researchers face liability if a patient reports […]

 

 

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