[Randomised phase II trials in oncology].
The purpose of phase II trials is to identify signals in favor of the efficacy of a drug in development. The main pitfall of a phase II study is to conclude by error that a drug has no activity, leading to a stop in the development of a drug which has a real efficacy. In oncology, more and more phase II trials are randomised, even though there are still numerous non randomised studies. Randomisation allows some control on the risk of patient selection bias, inherent to non randomised trials. This bias consists of recruiting by chance a population of patients with high risk or on the contrary low risk of response to the experimental treatment. The present paper describes the various types of randomised phase II trials, their principles, strengths and limits.
Piedbois
Pascal
P
AstraZeneca, 1, place Renault, 92844 Rueil-Malmaison Cedex. pascal.piedbois2@astrazeneca.com
D017322:Clinical Trials, Phase II as Topic / Q000379:methods* / Q000592:standards; D006801:Humans; D009369:Neoplasms / Q000628:therapy*; D011897:Random Allocation; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000592:standards; D015983:Selection Bias; D016896:Treatment Outcome