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

Menon, Usha, Gentry-Maharaj, Aleksandra, Burnell, Matthew, Apostolidou, Sophia, Ryan, Andy, Kalsi, Jatinderpal K., Singh, Naveena, Fallowfield, Lesley, McGuire, Alistair ORCID: 0000-0002-5367-9841, Campbell, Stuart, Skates, Steven J., Dawnay, Anne, Parmar, Mahesh and Jacobs, Ian J. (2023) Insights from UKCTOCS for design, conduct and analyses of large randomised controlled trials. Health Technology Assessment, 29 (10). 95 - 142. ISSN 1366-5278

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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.

Item Type:	Article
Additional Information:	© 2023 The Authors
Divisions:	Health Policy
Subjects:	R Medicine > RA Public aspects of medicine
Date Deposited:	05 Jun 2025 08:57
Last Modified:	26 Jun 2025 20:39
URI:	http://eprints.lse.ac.uk/id/eprint/128307

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