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Trials

, 17:150

First Online: 19 March 2016Received: 04 June 2015Accepted: 02 March 2016DOI: 10.1186-s13063-016-1273-9

Cite this article as: Hatfield, I., Allison, A., Flight, L. et al. Trials 2016 17: 150. doi:10.1186-s13063-016-1273-9

Abstract

Adaptive designs have the potential to improve efficiency in the evaluation of new medical treatments in comparison to traditional fixed sample size designs. However, they are still not widely used in practice in clinical research. Little research has been conducted to investigate what adaptive designs are being undertaken. This review highlights the current state of registered adaptive designs and their characteristics. The review looked at phase II, II-III and III trials registered on ClinicalTrials.gov from 29 February 2000 to 1 June 2014, supplemented with trials from the National Institute for Health Research register and known adaptive trials. A range of adaptive design search terms were applied to the trials extracted from each database. Characteristics of the adaptive designs were then recorded including funder, therapeutic area and type of adaptation. The results in the paper suggest that the use of adaptive designs has increased. They seem to be most often used in phase II trials and in oncology. In phase III trials, the most popular form of adaptation is the group sequential design. The review failed to capture all trials with adaptive designs, which suggests that the reporting of adaptive designs, such as in clinical trials registers, needs much improving. We recommend that clinical trial registers should contain sections dedicated to the type and scope of the adaptation and that the term ‘adaptive design’ should be included in the trial title or at least in the brief summary or design sections.

KeywordsAdaptive design Clinical trial Flexible design AbbreviationsADadaptive design

CIconfidence interval

DEdose escalation

DSdose selection

GSDgroup sequential design

MRCMedical Research Council

NIHRNational Institute for Health Research

RCTrandomised controlled trial

SSRsample size re-estimation

WHOWorld Health Organization

Electronic supplementary materialThe online version of this article doi:10.1186-s13063-016-1273-9 contains supplementary material, which is available to authorized users.

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Autor: Isabella Hatfield - Annabel Allison - Laura Flight - Steven A. Julious - Munyaradzi Dimairo

Fuente: https://link.springer.com/







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