Insights from UKCTOCS for design, conduct and analyses of large randomised controlled trials.

Autor:	Menon U; MRC Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK., Gentry-Maharaj A; MRC Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK., Burnell M; MRC Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK., Apostolidou S; MRC Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK., Ryan A; MRC Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK., Kalsi JK; Institute of Epidemiology and Health Care, University College London, London, UK., Singh N; Department of Cellular Pathology, Barts Health NHS Trust, London, UK., Fallowfield L; Sussex Health Outcomes Research and Education in Cancer (SHORE-C), Brighton and Sussex Medical School, University of Sussex, Brighton, UK., McGuire AJ; London School of Economics and Political Science, London, UK., Campbell S; Create Health, London, UK., Skates SJ; Massachusetts General Hospital and Harvard Medical School, Boston, USA., Dawnay A; Department of Clinical Biochemistry, Barts Health NHS Trust, London, UK., Parmar M; MRC Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK., Jacobs IJ; Department of Women's Cancer, Elizabeth Garrett Anderson Institute for Women's Health, University College London, London, UK.
Jazyk:	angličtina
Zdroj:	Health technology assessment (Winchester, England) [Health Technol Assess] 2023 Aug 23, pp. 1-38. Date of Electronic Publication: 2023 Aug 23.
DOI:	10.3310/CLDC7214
Abstrakt:	Abstract: Randomised controlled trials are challenging to deliver. There is a constant need to review and refine recruitment and implementation strategies if they are to be completed on time and within budget. We present the strategies adopted in the United Kingdom Collaborative Trial of Ovarian Cancer Screening, one of the largest individually randomised controlled trials in the world. The trial recruited over 202,000 women (2001-5) and delivered over 670,000 annual screens (2001-11) and over 3 million women-years of follow-up (2001-20). Key to the successful completion were the involvement of senior investigators in the day-to-day running of the trial, proactive trial management and willingness to innovate and use technology. Our underlying ethos was that trial participants should always be at the centre of all our processes. We ensured that they were able to contact either the site or the coordinating centre teams for clarifications about their results, for follow-up and for rescheduling of appointments. To facilitate this, we shared personal identifiers (with consent) with both teams and had dedicated reception staff at both site and coordinating centre. Key aspects were a comprehensive online trial management system which included an electronic data capture system (resulting in an almost paperless trial), biobanking, monitoring and project management modules. The automation of algorithms (to ascertain eligibility and classify results and ensuing actions) and processes (scheduling of appointments, printing of letters, etc.) ensured the protocol was closely followed and timelines were met. Significant engagement with participants ensured retention and low rates of complaints. Our solutions to the design, conduct and analyses issues we faced are highly relevant, given the renewed focus on trials for early detection of cancer. Future Work: There is a pressing need to increase the evidence base to support decision making about all aspects of trial methodology. Trial Registration: ISRCTN-22488978; ClinicalTrials.gov-NCT00058032. Funding: This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 16/46/01. The long-term follow-up UKCTOCS (2015 20) was supported by National Institute for Health and Care Research (NIHR HTA grant 16/46/01), Cancer Research UK, and The Eve Appeal. UKCTOCS (2001-14) was funded by the MRC (G9901012 and G0801228), Cancer Research UK (C1479/A2884), and the UK Department of Health, with additional support from The Eve Appeal. Researchers at UCL were supported by the NIHR UCL Hospitals Biomedical Research Centre and by the MRC Clinical Trials Unit at UCL core funding (MC_UU_00004/09, MC_UU_00004/08, MC_UU_00004/07). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, or the UK Department of Health and Social Care.
Databáze:	MEDLINE
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