In a traditional clinical trial, the design is fixed in advance, the study is carried out, and the data analysed after completion [1]. In contrast, adaptive designs pre-plan possible modifications on the basis of the data accumulating over the course of the trial as part of the trial proto...
The chapter then provides some examples regarding well-understood designs (adaptive group sequential design) and less well-understood designs (adaptive dose-finding design and two-stage phase II/III adaptive design with different study objectives and endpoints at different stages). Clinical/statistical ...
Adaptive clinical trial design has been proposed as a way to reduce the costs of phase II testing by providing earlier determination of futility and prediction of phase III success, reducing overall phase II and III trial sizes, and shortening overall drug development time. This review examines ...
Trial design Considering a slightly simplified version of the approach used for the OPTIMA trial, we assume that there are two biomarker-based tests, which are available for guiding treatment. Biomarker 1 is considered to be a gold standard that has previously been validated as a predictive biomar...
2.5PrinciplesofBayesianclinicaltrialdesign63 2.5.1Bayesianpredictiveprobabilitymethods64 viiiCONTENTS 2.5.2Bayesianindifferencezonemethods66 2.5.3Priordetermination68 2.5.4Operatingcharacteristics70 2.5.5Incorporatingcosts78 2.5.6Delayedresponse81 2.5.7Noncomplianceandcausalmodeling82 ...
Optimised clinical development plans using adaptive designs Our consulting teams can help you realise the potential of adaptive trial design by: Conducting simulation studies to demonstrate the value of an adaptive design trial over a conventional study Reviewing existing development strategies to identify ...
Our study will address some of the key issues involved in biomarker identification and clinical trial design. In our study, we propose two biomarker selection methods, and then apply them in two different clinical trial designs for targeted therapy development. In particular, we propose a Bayesian...
possible reasons for the hesitation: (i) confusion with respect to the definition of an ‘adaptive design’ (ii) controversy surrounding the use of sample size re-estimation methods; and (iii) logistical barriers that must be overcome in order to use adaptive designs within existing trial ...
TheSeptember 2018 releasereplaces the 2010 draft guidance issued by the FDA. The clinical trial landscape has changed since 2010 regards the FDA’s stance on adaptive clinical trial design. The guidance provides examples for Biostatisticians to review where adaptive designs have been featured. Use ca...
trial examples concerning the development of Velcade (intended for multiple myeloma and non-Hodgkin's lymphoma). Practical issues that are commonly encountered when implementing adaptive design methods in clinical trials are discussed in Section 5. Some concluding remarks are given in the last section....