A Practical Guide to Designing Phase II Trials in Oncology by Sarah R. Brown

By Sarah R. Brown

How to spot optimum part II trial designs

Providing a pragmatic advisor containing the data had to make an important judgements concerning section II trial designs, A functional advisor to Designing part II Trials in Oncology units forth particular issues for attention among the statistician and clinician whilst designing a part II trial, together with concerns akin to how the remedy works, number of final result degree and randomization, and contemplating either educational and views. A accomplished and systematic library of obtainable section II trial designs is integrated, saving time another way spent contemplating a number of manuscripts, and real-life functional examples of utilizing this method of layout section II trials in melanoma are given.

a pragmatic advisor to Designing section II Trials in Oncology:

  • Offers a based and sensible method of section II trial design.
  • Considers trial layout from either an educational and perspective.
  • Includes a dependent library of accessible section II trial designs.
  • Is proper to either scientific and statistical researchers in any respect levels
  • Includes genuine existence examples of employing this approach.
  • For these new to trial layout, A useful consultant to Designing part II Trials in Oncology may be a distinct and functional studying software, offering an creation to the options at the back of proficient choice making in part II trials. For more matured practitioners, the ebook will provide an summary of latest, much less well-known techniques to part II trial layout, offering replacement strategies to these which they might have formerly used. 



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Additional info for A Practical Guide to Designing Phase II Trials in Oncology

Example text

2010) or specific designs such as randomised designs, enrichment designs and adaptive Bayesian designs for trials of molecularly targeted agents only (Booth et al. 2008). Mariani and Marubini also previously conducted a review of the statistical methods available for phase II trials, categorising designs according to one sample versus controlled, as well as according to the number of stages of assessments, and focusing on a framework for trial analysis, that is, frequentist, Bayesian or decision theoretic (Mariani and Marubini 1996).

Alternatively, the interim analysis may be used to select which of several experimental treatments to take forward to the second stage. Additional adaptations may be incorporated at the end of the first stage according to the specific trial design, for example, sample size re-estimation. Stopping rules are developed for each stage of the study to determine whether to stop or continue, based on pre-specified operating characteristics relevant to the 28 A PRACTICAL GUIDE TO DESIGNING PHASE II TRIALS IN ONCOLOGY specific trial and design.

One study compared the results of multi-centre single-arm and randomised phase II trials of the same sample size, where the decision as to whether or not the experimental treatment was deemed successful was based solely on it showing a higher response rate than in the historical control population, or randomised control population, that is, no formally powered statistical comparison was employed (Taylor et al. 2006). Where there was expected to be little variability in response rates between centres, and both the variability and uncertainty in the response rate for the control population were small, single-arm studies were found to be adequate in terms of correct decision-making.

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