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 part II trial designs, A sensible 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 therapy works, collection of end result degree and randomization, and contemplating either educational and views. A complete and systematic library of accessible part II trial designs is integrated, saving time differently 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 functional method of section II trial design.
  • Considers trial layout from either an educational and perspective.
  • Includes a established library of accessible part II trial designs.
  • Is suitable to either scientific and statistical researchers in any respect levels
  • Includes genuine existence examples of making use of this approach.
  • For these new to trial layout, A sensible consultant to Designing part II Trials in Oncology can be a distinct and functional studying device, supplying an advent to the recommendations in the back of expert choice making in section II trials. For more matured practitioners, the ebook will supply an outline of latest, much less frequent ways to section II trial layout, supplying replacement ideas 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

Sample text

Similarly, the assessment of toxicity for combination treatments should also be addressed. 4 for further discussion). 4 Biomarker dependent Biomarkers are an increasingly important part of clinical trials. They can be defined as ‘a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention’ (Atkinson et al. 2001). Biomarkers may be considered in the design of phase II trials in two ways.

The thought process is made up of three stages: ∙ Stage 1 – Trial questions. This stage elicits information predominantly relating to the trial itself in relation to the treatment under investigation, the primary intention of the trial, number of arms and primary outcome of interest. ∙ Stage 2 – Design components. The information from the first stage feeds into the discussions relating to design components considering the outcome measure, randomisation (or not) and category of design, enabling attention to be focused on the specific statistical designs relevant to the trial.

The potential 16 A PRACTICAL GUIDE TO DESIGNING PHASE II TRIALS IN ONCOLOGY for a biomarker to identify a subpopulation of patients may, however, only become apparent after phase III investigation, as in the case of the monoclonal antibody cetuximab in colon cancer where efficacy is limited to patients with no mutation in the KRAS oncogene (Bokemeyer et al. 2009; Tol et al. 2009; Van Cutsem et al. 2009). Where available, using a biomarker to enrich the population in a phase II trial in this way can increase the likelihood of anti-tumour activity being identified, and thus speed up drug development.

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