Clinical trials : journal of the Society for Clinical Trials
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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 specifications, such as the choice of parametric dose-toxicity model and the initial guess of toxicity probabilities. ⋯ Based on simulations here, and many others not shown, CRM-L is almost as accurate, in many scenarios, as the nonparametric optimal design. On average, there appears to be very little margin for improvement. Even if a finely tuned skeleton offers some improvement over a simple skeleton, the improvement is necessarily very small.
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There are many benefits of data sharing, including the promotion of new research from effective use of existing data, replication of findings through re-analysis of pooled data files, meta-analysis using individual patient data, and reinforcement of open scientific inquiry. A randomized controlled trial is considered as the 'gold standard' for establishing treatment effectiveness, but clinical trial research is very costly, and sharing data is an opportunity to expand the investment of the clinical trial beyond its original goals at minimal costs. ⋯ The Data Share website offers researchers easy access to de-identified data files with the goal to promote additional research and identify new findings from completed CTN studies. To maximize the utility of the website, ongoing collaborative efforts are needed to standardize the core measures used for data collection in the CTN studies with the goal to increase their comparability and to facilitate the ability to pool data files for cross-study analyses.