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Adaptive designs in clinical trials: why use them, and how to run and report them.
Pallmann P, Bedding AW, Choodari-Oskooei B, Dimairo M, Flight L, Hampson LV, Holmes J, Mander AP, Odondi L, Sydes MR, Villar SS, Wason JMS, Weir CJ, Wheeler GM, Yap C, Jaki T. Pallmann P, et al. Among authors: sydes mr. BMC Med. 2018 Feb 28;16(1):29. doi: 10.1186/s12916-018-1017-7. BMC Med. 2018. PMID: 29490655 Free PMC article.
Changing platforms without stopping the train: experiences of data management and data management systems when adapting platform protocols by adding and closing comparisons.
Hague D, Townsend S, Masters L, Rauchenberger M, Van Looy N, Diaz-Montana C, Gannon M, James N, Maughan T, Parmar MKB, Brown L, Sydes MR; STAMPEDE and FOCUS4 investigators. Hague D, et al. Among authors: sydes mr. Trials. 2019 May 29;20(1):294. doi: 10.1186/s13063-019-3322-7. Trials. 2019. PMID: 31138292 Free PMC article.
This is a platform alteration: a trial management perspective on the operational aspects of adaptive and platform and umbrella protocols.
Schiavone F, Bathia R, Letchemanan K, Masters L, Amos C, Bara A, Brown L, Gilson C, Pugh C, Atako N, Hudson F, Parmar M, Langley R, Kaplan RS, Parker C, Attard G, Clarke NW, Gillessen S, James ND, Maughan T, Sydes MR; past and present members of the STAMPEDE and FOCUS4 Trial Management Group. Schiavone F, et al. Among authors: sydes mr. Trials. 2019 May 29;20(1):264. doi: 10.1186/s13063-019-3216-8. Trials. 2019. PMID: 31138317 Free PMC article.
Effective delivery of Complex Innovative Design (CID) cancer trials-A consensus statement.
Blagden SP, Billingham L, Brown LC, Buckland SW, Cooper AM, Ellis S, Fisher W, Hughes H, Keatley DA, Maignen FM, Morozov A, Navaie W, Pearson S, Shaaban A, Wydenbach K, Kearns PR; Experimental Cancer Medicine Centres (ECMC) CID trials working group. Blagden SP, et al. Br J Cancer. 2020 Feb;122(4):473-482. doi: 10.1038/s41416-019-0653-9. Epub 2020 Jan 6. Br J Cancer. 2020. PMID: 31907370 Free PMC article. Review.
The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design.
Dimairo M, Pallmann P, Wason J, Todd S, Jaki T, Julious SA, Mander AP, Weir CJ, Koenig F, Walton MK, Nicholl JP, Coates E, Biggs K, Hamasaki T, Proschan MA, Scott JA, Ando Y, Hind D, Altman DG; ACE Consensus Group. Dimairo M, et al. Trials. 2020 Jun 17;21(1):528. doi: 10.1186/s13063-020-04334-x. Trials. 2020. PMID: 32546273 Free PMC article.
258 results