PLAY THE WINNER FOR PHASE II/III CLINICAL TRIALS
β Scribed by Q. YAO; L. J. WEI
- Publisher
- John Wiley and Sons
- Year
- 1996
- Tongue
- English
- Weight
- 642 KB
- Volume
- 15
- Category
- Article
- ISSN
- 0277-6715
No coin nor oath required. For personal study only.
β¦ Synopsis
In comparing two treatments under a typical sequential clinical trial setting, a 50-50 randomization design generates reliable data for making efficient inferences about the treatment difference for the benefit of patients in the general population. However, if the treatment difference is large and the endpoint of the study is potentially fatal, it does not seem appropriate to sacrifice a large number of study patients who are assigned to the inferior arm. An adaptive design is a data-dependent treatment allocation rule that sequentially uses accumulating information about the treatment difference during the trial to modify the allocation rule for new study patients. In this article, we utilize real trials from AIDS and cancer to illustrate the advantage of using adaptive designs. Specifically we show that, with adaptive designs, the loss of power for testing the equality of two treatments is negligible. Moreover, the study patients do not have to pay a handsome price for the benefit of future patients. We also propose multi-stage adaptive rules to relax the administrative burden of implementing the study and to handle continuous response variables, such as the failure time in survival analysis.
π SIMILAR VOLUMES
We consider a clinical trial model comparing an experimental treatment with a control treatment when the responses are binary. For fixed significance level and power, we compare the expected number of treatment failures for two designsthe randomized play-the-winner rule and the triangular test. The
The objective of a phase II cancer clinical trial is to screen a treatment that can produce a similar or better response rate compared to the current treatment results. This screening is usually carried out in two stages as proposed by Simon. For ineffective treatment, the trial should terminate at
## Abstract Traditional drug development consists of a sequence of independent trials organized in different phases. Full development typically involves (i) a learning phase II trial and (ii) one or two confirmatory phase III trial(s). For example, in the phase II trials several doses of the new co