Research

Good news: significant performance improvements

Heather Slade, acting Head of Research Management and Governance at the CCRN, recently wrote to the Specialty Group Chairs to congratulate them on improved performance figures for the study approval process. "The process for providing NHS permissions (CSP) within study set up has undergone some significant service reviews and improvements over the last twelve months. We are very pleased with the improvements we have delivered - the average time to complete study wide reviews and the average time to complete local reviews were just 21 days for 12/13, a five-fold improvement on previous years... obtaining R&D approvals is very rarely the block that it used to be... researchers [should] understand that they should get planning much earlier than they used to in order to be ready to recruit patients after a rapid approval... There is much to celebrate and we would like to thank you and your Specialty Group for the huge role you have played, and continue to play, in supporting the successful delivery of research in the NHS."

If you have examples of rapid approvals or other ways in which the CRN has helped with study set-up (eg site identification and the rapid deployment of staff), please send them by 23rd July to This e-mail address is being protected from spambots. You need JavaScript enabled to view it . It would be helpful if examples could include reference to:

1. Title of study and UKCRN ID
2. What your role was with the study: CI/PI etc.
3. By which Specialty Group was the study led?
4. How quickly did the CSP and NIHR teams deliver NHS permissions for this study?
5. Did the network help in other ways with study set up?
6. What impact did this have on the overall delivery of the study?

Clinical Trial Details from the NIHR

The NIHR has now made a public-facing version of the UK Oral and Gastrointestinal Study Portfolio; here you can access details of GI and hepatology studies that are recruiting or are being set-up, as well as those that have closed or been suspended. Studies can be searched by country (England, Northern Ireland, Scotland or Wales) and by various other criteria. A user guide is available via a link on the site. Output can be exported to Excel for easy reference. This information should be updated on a frequent (at least monthly) basis, and covers all trials in the portfolio. Any BSG member who wishes to call particular attention to a study (via the BSG's website or e-news) should send a brief summary with all relevant details, deadlines and contact information to This e-mail address is being protected from spambots. You need JavaScript enabled to view it .

If you are a patient or carer, or perhaps a member of the public with an interest, you can help research. You could become a participant in a clinical research study that may benefit many people. You could even help shape clinical research by becoming more actively involved and having a say. Access information about the importance of clinical research, taking part, and how you could help influence the research that gets carried out.

TOPPIC

Update: March 2012

TOPPIC reached its target recruitment of 234 patients on 14 March 2012. It required a huge amount of work from staff across 34 hospitals to accomplish this and we are very proud to have reached this milestone, having been given the opportunity to prove we could complete the study when given an extension by the MRC. Professor Satsangi wishes to thank everyone for taking part in the largest study in post-operative Crohn's disease ever carried out.

Background: TOPPIC was a multicentre RCT of the efficacy of 6MP in the prevention of recurrence of Crohn’s Disease after ileo-colonic or small bowel resection. Patients were recruited within 3 months of surgery and received 6MP or placebo for up to 3 years (156 weeks) and attended 12 study visits during this time. As of March 2011, TOPPIC Recruitment stood at 142 randomised patients. As such, the study had overtaken previous studies in this field, and the investigators hoped to provide a definitive answer to the unresolved issue as to the role of thiopurines in prevention of post-operative recurrence in Crohn's disease. 2011 got off to a very strong start in terms of recruitment and all sites were thanked. A further 92 patients had to be recruited to reach the target of 234, with only 13 months left. There were 27 sites throughout the UK, with 4 more still seeking approval as of March 2011, and TOPPIC was closed to any further new sites. A series of roadshows was being undertaken to address recruitment issues.

Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

or the TOPPIC office ( This e-mail address is being protected from spambots. You need JavaScript enabled to view it ).

HOT II Trial Update

Update on HOT II Trial – Last call for volunteers

Following a further extension of the accrual period for HOT II, 75% of the target sample has undergone the consent process. Treatment is delivered at participating hyperbaric medicine centres in Cardiff, Chichester, Great Yarmouth, Hull, London (Leytonstone and St John's Wood), Plymouth, Poole and Rugby. Assessments are carried out at the Royal Marsden Hospital in London, with the option of postal consent for patients unable to make more than one journey.

As there is a 3-month run-in period, accrual needs to finish at the end of March 2012 in order for all volunteers to be treated by the end of the year. Although there is a list of patients in work-up for the study, the trial is still looking for 5-10 additional volunteers who may be interested in taking part. The HOT II Trial Coordinator would therefore be grateful if you could let her know of any potentially suitable volunteers amongst your patients AS SOON AS POSSIBLE.

For further information or to refer a patient, please see below.
Thank you for your help.

Grace Sharp
HOT II Trial Coordinator

HOT II summary and contact details

HOT II is a randomised double-blind controlled phase III trial of hyperbaric oxygen in patients suffering long-term adverse effects of radiotherapy (RT) for pelvic cancer, funded by Cancer Research UK and the Department of Health (ISRCTN 86894066). It aims to test the efficacy of HBO in permanently reducing gastrointestinal symptoms caused by pelvic radiotherapy at least 12 months before and which persist despite optimal gastroenterological management.

If you have patients with chronic RT-induced symptoms in your clinic who fit the following main inclusion criteria:
- Past history of cancer of the rectum, prostate, testis, bladder, uterine cervix, uterine corpus or ovary
- Bowel symptoms due to RT: diarrhoea, faecal incontinence, bleeding etc
- Radiotherapy at least 12 months ago
please ask them to contact Grace Sharp This e-mail address is being protected from spambots. You need JavaScript enabled to view it , or forward their contact details to her. She will send them a copy of the patient information sheet and establish eligibility.

Chief & Principal Investigators:
Dr Jervoise Andreyev, Consultant Gastroenterologist in Pelvic Radiation Disease
Prof John Yarnold, Consultant Clinical Oncologist

For further information, please see Royal Marsden HOT-II or contact Grace Sharp directly at the address below:
Grace Sharp
HOT II Trial Coordinator
Professor Yarnold's Office
Royal Marsden Hospital, Downs Road, Sutton, Surrey SM2 5PT
Tel: 0208 661 3273, Fax: 0208 661 3107, Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

PRED4 - rare adverse events studies

The UK IBD Genetics Consortium has started recruitment for the PRED4 study, which is now open in a number of sites. The team is currently busy opening the rest of the sites in the UK (similar to the 5-ASA-induced nephrotoxicity study). These studies are investigating drug-related rare adverse events and aim to identify clinically useful genetic markers that predict serious drug side effects, in particular:
• Thiopurine-induced pancreatitis
• Thiopurine-induced leucopaenia
• Anti-TNF-induced demyelination
• PPI-induced nephritis.

Further information can be found at UK IBD Genetics Consortium and in the attached file.

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