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Pre-trial inter-laboratory analytical validation of the FOCUS4 personalised therapy trial.
Richman SD, Adams R, Quirke P, Butler R, Hemmings G, Chambers P, Roberts H, James MD, Wozniak S, Bathia R, Pugh C, Maughan T, Jasani B; FOCUS4 Trial Management Group. Richman SD, et al. J Clin Pathol. 2016 Jan;69(1):35-41. doi: 10.1136/jclinpath-2015-203097. Epub 2015 Sep 7. J Clin Pathol. 2016. PMID: 26350752 Free PMC article. Clinical Trial.
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. Trials. 2019 May 29;20(1):264. doi: 10.1186/s13063-019-3216-8. Trials. 2019. PMID: 31138317 Free PMC article.