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Review
. 2016 Mar 19;17(1):150.
doi: 10.1186/s13063-016-1273-9.

Adaptive designs undertaken in clinical research: a review of registered clinical trials

Isabella Hatfield  1   2 , Annabel Allison  2   3 , Laura Flight  2 , Steven A Julious  2 , Munyaradzi Dimairo  4
Affiliations
Review

Adaptive designs undertaken in clinical research: a review of registered clinical trials

Isabella Hatfield et al. Trials. .

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.

Keywords: Adaptive design; Clinical trial; Flexible design.

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Figures

Fig. 1
Fig. 1
Search strategy. A flow diagram of the decision-making process used to determine the search terms. WHO World Health Organization
Fig. 2
Fig. 2
Screening process. A flow diagram showing the review process including reasons for exclusion of trials. NIHR National Institute for Health Research
Fig. 3
Fig. 3
Bar chart showing the number of ADs per year. Only complete years are represented. AD adaptive design
Fig. 4
Fig. 4
Bar chart showing the number of ADs per year by phase. Only complete years are represented. AD adaptive design
Fig. 5
Fig. 5
Forest plot of the number of ADs per 10,000 registered trials by each time period. Only complete years are represented. AD adaptive design
Fig. 6
Fig. 6
Clustered bar chart showing the number of ADs by phase and funder. AD adaptive design
Fig. 7
Fig. 7
Bar chart showing the number of ADs by geographic location. AD adaptive design
Fig. 8
Fig. 8
MEDLINE process. A flow diagram of the MEDLINE search process. GSD group sequential design
See this image and copyright information in PMC

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