4 Focus on FIT Developing an Evidence Base for NHS England The NICE FIT Study – 6 Months on… The NICE FIT study was launched through Croydon University Hospital in early 2017, as a diagnostic accuracy study for faecal immunochemical testing (FIT). Following the introduction of NICE DG301 the study has grown significantly in size. After the first pilot, the study, based initially at Croydon University Hospital, was expanded under the direction of chief investigator Mr Muti Abulafi and coinvestigator, Mr Nigel D’Souza. Working with Royal Marsden Partners (RM Partners) the aim is for multi-centre recruitment throughout England. As one of the largest studies conducted on FIT, Alpha Laboratories’ Senior Product Manager, Matthew Davis, spoke with Mr D’Souza to find out about the latest progress with the NICE FIT Study. What prompted the initial push for the NICE FIT Study? The colorectal department at Croydon screens all two-week-wait (2WW) referrals for symptomatic patients with suspected bowel cancer. While referrals have been steadily increasing over the last 10 years, they have doubled since 2015. The change in NICE NG12 to include more low risk patients could be a source of rising referrals. The decision within London not to test these patients for FOBT prior to referral may be another reason. Due to the low sensitivity of FOB, it was considered a ‘coin-toss test’ – with a 50:50 chance of going to colonoscopy. How did you obtain the funding for the study? The initial pilot had no funding. It was only possible with a lot of goodwill from many parties. Patients were recruited through the endoscopy department, and analysis was performed by Sally Benton’s team in the Bowel Cancer Screening Southern Hub (Guildford). Kits were supplied free-of-charge by Alpha Laboratories Ltd who also arranged sample transport. I screened patients and coordinated this in my own time. Now the study is expanding, what helped you to obtain new funding? A combination of factors; first of all, early diagnosis is key to the "Five Year Forward View" for early cancer diagnosis. This makes FIT very attractive as a simple dipstick test to rule out bowel cancer, instead of putting all these patients onto the two week wait pathway. The Sustainability and Transformation Plan (STP4) for saving money was also a major benefit factor: comparing a £9.00 FIT to a £375 colonoscopy1 makes the argument easier to emphasize. We submitted the bid on behalf of RM Partners and with their support, they submitted the bid as part of the STP funding. So RM Partners did the pitch to NHS England? Yes – we drew up the basic cost savings, projections, and methodology for the project. We couldn’t have done it without their support. Dr Michelle Chen and Professor Stan Kaye from the R&D team have been instrumental in supporting our initial roll-out and subsequent expansion. The study has been running some months, and now you’ve recruited additional hospitals: how is that progressing? When we first designed our study, we weren’t sure we would achieve NIHR badge approval. The initial model involved recruiting patients directly from RM Partner sites in London, using our own research nurses, who would be hired with funding. However, when we were awarded badge approval onto the NIHR portfolio, Dr Michelle Chen recommended recruitment via a colorectal nurse (CRN), to facilitate recruitment to more sites both in and outside of London. As a portfolio study, hospitals are awarded funding for each patient recruited to the study. So with the high volume this was an attractive proposition for hospitals. By recruiting patients from outside London, has the thrust of the study changed at all? Our main goal is (and will remain) to recruit 5,500 patients from London to prove the diagnostic accuracy of FIT in diverse populations. This is the main thrust of the study. Portfolio adoption enables additional (nonLondon) recruitment, because NHS England wants as much data on FIT as possible. Fortunately, our study methodology for London recruitment can be scaled to recruit across sites throughout England. The work was within our scope, so we could support the additional roll out. The local hospitals, R&D departments and CRNs will play a larger role in recruitment, but ultimately we remain responsible for the data management and quality assurance. Logistically, how does this work with the London and non-London sites? For London sites, the hospital sends the patient information to us, and we arrange to have the FIT kit sent to the patient. Outside London the hospitals do the recruitment work themselves. The samples, regardless of where they were sent from, are all returned to Sally’s team at the Guildford Hub, and the data generated is sent straight back to us at Croydon. Why is it so important for the data to come straight to you? It’s very important that the data come back to us. When examining a colonoscopy report, it can be challenging for a non-clinician to accurately classify the findings. During the pilot, we noticed many coding errors on the system, where findings had been incorrectly coded on the system. To ensure the data is as accurate as possible, the findings are logged onto our bespoke system by a member of the local CRN. The NICE FIT Study Team: Left to Right: Dr John Chang, Croydon University Hospital R&D Director Mrs Carlene Parchment, NICE FIT Trial Manager Mr Muti Abulafi, Chief Investigator Mrs Antoinette Dzakpasu, NICE FIT Coordinator Dr Michelle Chen, RM Partners R&D Manager Mr Nigel D’Souza, Co-Investigator
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