clinical trialreviewhistoryregulationpolicyFDAEMAdata monitoring committeeThis review investigates characteristics of implemented adaptive design clinical trials and provides examples of regulatory experience with such trials. Review of adaptive design clinical trials in EMBASE, PubMed, Cochrane Registry of ...
(multicenter, single-center), whether a trial was international or not, trial clinical phase, adaptive design type, area of disease, type of control (active, non-active, both), type of primary outcome, expected sample size, randomized sample size, and funding source (government, private for-...
AD adaptive (trial) design CV cardiovascular EMA European Medicines Agency FDA Food and Drug Administration FDR false discovery rate HF heart failure RP-II randomized phase II studies SA-II single-arm phase II studies Human clinical trials for drug development traditionally progress from small toxicity...
Faced with the high cost and limited efficiency of classical randomized controlled trials, researchers are increasingly applying adaptive designs to speed up the development of new drugs. However, the application of adaptive design to drug randomized con
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...
20% of clinical trials in 2013 used an adaptive design 30-60% Potential cost savings 250+ Adaptive clinical trials for over 30 sponsors globally ICON offers design, simulation and execution of adaptive clinical trials. We have: More than twenty years of experience in successfully planning and...
Key design considerations for adaptive clinical trials: a primer for clinicians Adaptive designs have mostly been used in trials evaluating drugs, but their use is spreading. The US Food and Drug Administration recently issued guidance on adaptive trial designs, which highlighted general principles and...
Müller HH, Schäfer H (2004) A general statistical principle for changing a design any time during the course of a trial. Stat Med 23:2497–2508 CrossRef Point to consider on multiplicity issues in clinical trials. European Medicines Agency EMA CHMP/EWP/908/99 September 2002. http://www...
The FDA adaptive trial design guidance (1) is a thoughtful but lengthy document that explains on 50 pages wide-ranging and important topics "such as ... what aspects of adaptive design trials (i.e., clinical, statistical, regulatory) call for special consideration, ... when to interact with...
Explanation—Operating characteristics, which relate to the statistical behaviour of a design, should be tailored to address trial objectives and hypotheses, factoring in logistical, ethical, and clinical considerations. These may encompass the maximum sample size, expected sample sizes under certain scenar...