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

By Sarah R. Brown

How to spot optimum section II trial designs

Providing a realistic consultant containing the data had to make an important judgements relating to part II trial designs, A useful consultant to Designing section II Trials in Oncology units forth particular issues for attention among the statistician and clinician while designing a section II trial, together with concerns similar to how the remedy works, collection of end result degree and randomization, and contemplating either educational and views. A accomplished and systematic library of obtainable part II trial designs is incorporated, saving time differently spent contemplating a number of manuscripts, and real-life sensible examples of utilizing this method of layout section II trials in melanoma are given.

a realistic consultant to Designing part II Trials in Oncology:

  • Offers a dependent and functional method of section II trial design.
  • Considers trial layout from either an educational and perspective.
  • Includes a established library of obtainable part II trial designs.
  • Is proper to either scientific and statistical researchers in any respect levels
  • Includes actual lifestyles examples of using this approach.
  • For these new to trial layout, A useful consultant to Designing section II Trials in Oncology can be a special and sensible studying instrument, supplying an creation to the strategies in the back of expert choice making in section II trials. For more matured practitioners, the booklet will provide an outline of recent, much less primary techniques to part II trial layout, offering substitute strategies to these which they might have formerly used. 

 

 

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Extra resources for A Practical Guide to Designing Phase II Trials in Oncology

Example text

The intention of this book is to present researchers with the designs available to them for their specific trial, rather than to recommend one design over another. In doing so we incorporate the well-established designs of Gehan (1961), Fleming (1982) and Simon (1989), as well as bringing lesser known designs to the attention of researchers, allowing the user to make informed choices regarding trial design. A brief overview of each design identified is presented; however, the technical detail of each design is omitted and may be further evaluated by considering the complete references, as appropriate.

This does not infer that a comparison may not be made of outcomes between the arms; rather, that these comparisons be made with the acknowledgement of reduced statistical power therefore providing additional exploratory comparisons only. This approach may be appropriate if it is sufficient to KEY POINTS FOR CONSIDERATION 25 simply show that the experimental treatment has activity within a certain range. Randomisation provides a level of reassurance that the study population is representative and guards against patient selection bias; this approach is more acceptable when at least some historical data exist to further aid interpretation of the activity of the investigational agent.

2010). A model that is increasingly relevant to the development of targeted anticancer agents is to incorporate proof of concept translational imaging and/or molecular/biomarker studies within the expanded cohort of patients treated at the recommended phase II dose in a phase I trial. Where clear proof of concept can KEY POINTS FOR CONSIDERATION 17 be demonstrated in this way, there is a blurring of the conventional divide between phase I and IIa studies but the need remains for a subsequent phase IIb trial with the intention of making a formal decision regarding further evaluation in a phase III trial.

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