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

a pragmatic consultant to Designing section II Trials in Oncology:

  • Offers a established and useful method of section II trial design.
  • Considers trial layout from either an educational and perspective.
  • Includes a dependent library of accessible part II trial designs.
  • Is proper to either scientific and statistical researchers in any respect levels
  • Includes genuine existence examples of utilising this approach.
  • For these new to trial layout, A useful consultant to Designing section II Trials in Oncology should be a special and useful studying instrument, delivering an advent to the ideas in the back of proficient determination making in part II trials. For more matured practitioners, the ebook will supply an summary of latest, much less commonplace methods to section II trial layout, supplying replacement ideas to these which they could have formerly used. 

 

 

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

Example text

Additional categories of design that Mariani and Marubini (Mariani and Marubini 1996) did not consider are also included. 1 One-stage A one-stage design utilises a fixed sample of patients, recruited until the required sample size is obtained. After the necessary follow-up of patients, analysis and decision-making regarding proof of concept, whether to move to phase III or not, or which treatment(s) to select to take forward to phase III, is made. One-stage designs are relatively straightforward, avoiding complexities relating to recruitment strategies if interim analyses are undertaken.

Where multiple experimental treatments are available, or a single treatment that may be effective using different doses or schedules, a phase II trial may be designed to select which, if any, of these options should be taken forward for phase III evaluation. Randomisation can also be used to evaluate multiple treatment strategies such as the sequence of first- and second-line treatments. In these settings assessment of activity of each individual novel treatment, based on pre-specified minimal levels of activity, can be assessed using treatment selection designs which are described in Chapter 5.

In the majority of cases there will be more than one statistical design that suits the pre-specified trial parameters determined via the thought process. In such cases, the final stage in the thought process, that of practical considerations, may allow a choice to be made between the alternatives. On the other hand, that choice may be based on previous experience or assessment of various trial scenarios by mathematical modelling or simulation. Further detail on choosing between multiple designs is provided in Chapter 2.

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