Authors
Usha Menon, Aleksandra Gentry-Maharaj, Matthew Burnell, Sophia Apostolidou, Andy Ryan, Jatinderpal K Kalsi, Naveena Singh, Lesley Fallowfield, Alistair J McGuire, Stuart Campbell, Steven J Skates, Anne Dawnay, Mahesh Parmar, Ian J Jacobs
Publication date
2023/8/23
Journal
Health Technology Assessment
Pages
1-38
Description
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 …
Scholar articles
U Menon, A Gentry-Maharaj, M Burnell, S Apostolidou… - Health Technology Assessment, 2023