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2018 ; 10
(ä): 343-351
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Critical concepts in adaptive clinical trials
#MMPMID29606891
Park JJ
; Thorlund K
; Mills EJ
Clin Epidemiol
2018[]; 10
(ä): 343-351
PMID29606891
show ga
Adaptive clinical trials are an innovative trial design aimed at reducing
resources, decreasing time to completion and number of patients exposed to
inferior interventions, and improving the likelihood of detecting treatment
effects. The last decade has seen an increasing use of adaptive designs,
particularly in drug development. They frequently differ importantly from
conventional clinical trials as they allow modifications to key trial design
components during the trial, as data is being collected, using preplanned
decision rules. Adaptive designs have increased likelihood of complexity and also
potential bias, so it is important to understand the common types of adaptive
designs. Many clinicians and investigators may be unfamiliar with the design
considerations for adaptive designs. Given their complexities, adaptive trials
require an understanding of design features and sources of bias. Herein, we
introduce some common adaptive design elements and biases and specifically
address response adaptive randomization, sample size reassessment, Bayesian
methods for adaptive trials, seamless trials, and adaptive enrichment using real
examples.