By Sarah R. Brown
How to spot optimum part II trial designs
Providing a pragmatic advisor containing the data had to make the most important judgements relating to section II trial designs, A sensible 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 corresponding to how the remedy works, selection of end result degree and randomization, and contemplating either educational and views. A accomplished and systematic library of accessible section II trial designs is incorporated, saving time another way spent contemplating a number of manuscripts, and real-life sensible examples of utilizing this method of layout part II trials in melanoma are given.
a pragmatic consultant to Designing part II Trials in Oncology:
- Offers a dependent and useful method of section II trial design.
- Considers trial layout from either an educational and perspective.
- Includes a based library of obtainable section II trial designs.
- Is appropriate to either scientific and statistical researchers in any respect levels
- Includes genuine lifestyles examples of utilising this approach.
- For these new to trial layout, A functional advisor to Designing section II Trials in Oncology could be a distinct and useful studying instrument, supplying an advent to the recommendations in the back of expert selection making in section II trials. For more matured practitioners, the ebook will supply an outline of recent, much less frequent ways to part II trial layout, supplying replacement recommendations to these which they might have formerly used.
Read or Download A Practical Guide to Designing Phase II Trials in Oncology PDF
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Extra info for A Practical Guide to Designing Phase II Trials in Oncology
Single-arm phase II designs have been reported that utilise historical data but incorporate an estimate of potential variability arising from the number of patients or trials from which those historical data have been derived, and are presented in Chapter 3. A single-arm study may be considered appropriate where ∙ comparison with a control group is not relevant. For example, a phase IIa trial designed to show proof of concept, where the intention is to obtain an initial estimate of treatment activity to inform the design of a randomised phase IIb trial; ∙ the historical data are sufficiently robust for the primary outcome measure as to allow a reliable comparison, for example, a study of a single-agent cytotoxic treatment with response rate as the primary outcome measure, conducted in a broad population of patients with a common cancer refractory to standard therapy.
33 has been proposed as clinically relevant, but this threshold has not been validated (Von Hoff 1998). Time-to-event ratios may, however, be worthy of consideration as a phase II outcome measure where randomisation is not appropriate. 2 Randomisation The use of randomisation in phase II trials is widely debated (Buyse 2000; Redman and Crowley 2007; Yothers et al. 2006). Randomisation protects against selection bias, 22 A PRACTICAL GUIDE TO DESIGNING PHASE II TRIALS IN ONCOLOGY balances treatment groups for prognostic factors and contributes towards ensuring a valid comparison of the treatments under investigation, such that any treatment effect observed can reasonably be attributed to the treatment under investigation and not external confounding factors.
The process provides an overview of the key stages and elements for consideration during the phase II trial design process. Each of these elements should be worked through in turn in an iterative manner as information derived at earlier stages feeds in to design choices and decisions in the latter stages and consideration of alternative designs. 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.
A Practical Guide to Designing Phase II Trials in Oncology by Sarah R. Brown