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A literature review of applied adaptive design methodology within the field of oncology in randomised controlled trials and a proposed extension to the CONSORT guidelines
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Mistry, Pankaj, Dunn, Janet A. and Marshall, A. (Andrea) (2017) A literature review of applied adaptive design methodology within the field of oncology in randomised controlled trials and a proposed extension to the CONSORT guidelines. BMC Medical Research Methodology, 17 (1). 108. doi:10.1186/s12874-017-0393-6 ISSN 1471-2288.
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Official URL: http://doi.org/10.1186/s12874-017-0393-6
Abstract
Background:
The application of adaptive design methodology within a clinical trial setting is becoming increasingly popular. However the application of these methods within trials is not being reported as adaptive designs hence making it more difficult to capture the emerging use of these designs. Within this review, we aim to understand how adaptive design methodology is being reported, whether these methods are explicitly stated as an 'adaptive design' or if it has to be inferred and to identify whether these methods are applied prospectively or concurrently.
Methods:
Three databases; Embase, Ovid and PubMed were chosen to conduct the literature search. The inclusion criteria for the review were phase II, phase III and phase II/III randomised controlled trials within the field of Oncology that published trial results in 2015. A variety of search terms related to adaptive designs were used.
Results:
A total of 734 results were identified, after screening 54 were eligible. Adaptive designs were more commonly applied in phase III confirmatory trials. The majority of the papers performed an interim analysis, which included some sort of stopping criteria. Additionally only two papers explicitly stated the term 'adaptive design' and therefore for most of the papers, it had to be inferred that adaptive methods was applied. Sixty-five applications of adaptive design methods were applied, from which the most common method was an adaptation using group sequential methods.
Conclusion:
This review indicated that the reporting of adaptive design methodology within clinical trials needs improving. The proposed extension to the current CONSORT 2010 guidelines could help capture adaptive design methods. Furthermore provide an essential aid to those involved with clinical trials.
Item Type: | Journal Article | ||||||
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Subjects: | R Medicine > R Medicine (General) | ||||||
Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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SWORD Depositor: | Library Publications Router | ||||||
Library of Congress Subject Headings (LCSH): | Clinical trials -- Design, Clinical trials -- Reporting, Oncology, Medical research -- Literature | ||||||
Journal or Publication Title: | BMC Medical Research Methodology | ||||||
Publisher: | BioMed Central Ltd. | ||||||
ISSN: | 1471-2288 | ||||||
Official Date: | 18 July 2017 | ||||||
Dates: |
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Volume: | 17 | ||||||
Number: | 1 | ||||||
Number of Pages: | 9 | ||||||
Article Number: | 108 | ||||||
DOI: | 10.1186/s12874-017-0393-6 | ||||||
Status: | Peer Reviewed | ||||||
Publication Status: | Published | ||||||
Reuse Statement (publisher, data, author rights): | ** From PubMed via Jisc Publications Router. ** History: ** received: 20-03-2017 ** accepted: 10-07-2017 | ||||||
Access rights to Published version: | Open Access (Creative Commons) | ||||||
Date of first compliant deposit: | 3 August 2017 | ||||||
Date of first compliant Open Access: | 3 August 2017 |
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