Adaptive design clinical trials: a review of the literature and ClinicalTrials.gov.

ABSTRACT:

Objectives

This review investigates characteristics of implemented adaptive design clinical trials and provides examples of regulatory experience with such trials.

Design

Review of adaptive design clinical trials in EMBASE, PubMed, Cochrane Registry of Controlled Clinical Trials, Web of Science and ClinicalTrials.gov. Phase I and seamless Phase I/II trials were excluded. Variables extracted from trials included basic study characteristics, adaptive design features, size and use of independent data monitoring committees (DMCs) and blinded interim analyses. We also examined use of the adaptive trials in new drug submissions to the Food and Drug Administration (FDA) and European Medicines Agency (EMA) and recorded regulators' experiences with adaptive designs.

Results

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SUBMITTER: Bothwell LE 

PROVIDER: S-EPMC5829673 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature