Completeness of Reporting of Patient-Relevant Clinical Trial Outcomes: Comparison of Unpublished Clinical Study Reports with Publicly Available Data
PLOSONE: 10/8/13 Access to unpublished clinical study reports (CSRs) is currently being discussed as a means to allow unbiased evaluation of clinical research. The Institute for Quality and Efficiency in Health Care (IQWiG) routinely requests CSRs from manufacturers for its drug assessments. Our objective was to determine the information gain from CSRs compared to publicly […]
Application of methods for central statistical monitoring in clinical trials
Clin Trials: October 1, 2013 Background On-site source data verification is a common and expensive activity, with little evidence that it is worthwhile. Central statistical monitoring (CSM) is a cheaper alternative, where data checks are performed by the coordinating centre, avoiding the need to visit all sites. Several publications have suggested methods for CSM; however, few have […]
Integrating biomarker information within trials to evaluate treatment mechanisms and efficacy for personalised medicine
Clin Trials: September 2, 2013 Background The development of personalised (stratified) medicine is intrinsically dependent on an understanding of treatment-effect mechanisms (effects on therapeutic targets that mediate the effect of the treatment on clinical outcomes). There is a need for clinical trial data for the joint evaluation of treatment efficacy, the utility of predictive markers as indicators […]
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 […]
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 […]
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 […]
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 […]
