UK DCTN AGM/Steering Group Meeting BAD Conference ACC Liverpool 10 July 2013 Attendees: H Williams (Chair), M McPhee, C Layfield, N Levell, F Meredith, R Abbott, E Pynn, A Layton, A Alexandroff, A Ghazavi, A Steen, J Ingram, D Rallan, H Bell, M Walsh, A Yong, F Humphreys, L Mitchell, S George, E Veysey, P Thomson, M Wittmann, I Haq. Apologies: K Thomas, A Roberts, J Clayton, V Madhok, A Makrygeorgou, C Smith, S Taibjee, S Langan, A Nunn. Action Action Owner Discuss details for a joint small grants award with BSF (Bill Cunliffe) C Layfield/H Williams Send information on ALPHA study to J Chalmers M Wittmann Investigate ‘Easy fundraising’ M McPhee Draft possible process for joint BSF/UKDCTN funding award H Williams Date due Done Minutes  Welcome H Williams welcomed everyone and introduced four new steering group members; Frances Humphreys, Inaam Haq, Maeve Walsh and Miriam Wittmann.  Minutes and actions from previous meeting Minutes of the last meeting were accepted as true record and all actions have been completed.  Treasurers report H Williams thanked Shernaz for a donation made earlier this year. H Williams announced the themed call for 2014 will be dermatology surgery. C Layfield provided a summary of the charity finances. Total non-committed funds at this date is £71,358. A final payment from the SPRUSD programme grant had been made. It was warned that charitable funds are likely to run out in the next three years unless another source of income is found. It is important for us to receive a funding contribution from studies we have assisted in developing and promoting. In future we will continue to request a contribution commensurate with the funding source (eg a major HTA trials should contribute around £10k as exemplified by the recent successful BEEP study) in funding applications made by studies developed and promoted with our involvement. A list of supporting activities will be drafted for applicants to add to their funding applications.  Report to BAD A report to the BAD has been submitted (They have funded the senior clinical trials development manager post). It has been a busy year with the PATCH cellulitis results released in the New England Journal of Medicine, which has had an impact worldwide. Five studies have received funding: Clothes for eczema, Hi-Light for vitiligo, BEEP eczema prevention study, ELP pilot work, and the SPOT skin cancer prevention study. There followed a discussion about improving the income of the UKDCTN and the following suggestions were made: - Consider joining up British Epidermo-Epidemiology Society (BEES) and UKDCTN as one charity at some stage? - Run more BEES courses to generate profit to donate to UKDCTN (currently profits go back into the BEES organisation to fund two developing country attendees) - Any education courses should map onto the SpR curriculum - Invite other specialties that have a large number of trainees for critical appraisal skills courses and basic statistics (interdisciplinary courses) - Run online courses or combined online & face to face courses - Education programme for research nurses - Register for ‘easy fundraising’ and ask all members to sign up. - Combine funds with British Skin Foundation (BSF) to help our funds last longer i.e. £7.5 K matched funding for a joint annual award of £15k. There followed a short discussion about working with the BSF. General view was that it is a good idea and it is beneficial to collaborate in this way, but problems may arise with decision making due to differing interests. We will need to discuss and agree a process beforehand so that administering and agreeing on the award should run smoothly. H Williams to draft a possible process to administer a joint BSF /UKDCTN grant award.  New vignette: ALPHA (Alitretinoin vs PUVA for severe Hand eczema), Miriam Wittmann (Leeds) This vignette has been put together in response to a re-advertisment of a HTA call on treatments for chronic hand eczema. The trial development team have been invited to submit a full proposal. A large team is in place supporting the study, with support from Leeds CTU. Initial problems: - Agreeing on suitable comparators for study - lack of current literature (only 1 study compared alitretinoin) - no long term follow up data available - alitretinoin is the only licensed systemic treatment for hand eczema A survey was circulated by UKDCTN to assess common practice. The survey found that topical PUVA was the first choice treatment for many. There was a spread of opinion on which had the best long term outcome; most considered alitretinoin and PUVA had the best long term outcome but a large number of respondents (20%) stated they did not know what best to use. The UKDCTN survey was critical in helping to determine the most appropriate comparator for alitretinoin, especially as hand/foot PUVA had not been proposed as teh front runner in the previous trial development group. In summary, the study will be a multi centre, prospective, open label 2 arm parallel group comparing alitretinoin vs PUVA as 1st line treatment for steroid resistant chronic hand eczema for 12 weeks. Plan to use HECSI score. Secondary outcomes include long term outcomes 24 – 60 weeks, remission rates, Quality of life/ patient benefit. Will also conduct comparison of scoring systems. Further discussion is ongoing with regard to: - duration of PUVA treatment - time to relapse vs minimum disease activity - to allow steroids and moisturisers during study? - Stratification Those present raised the following issues:  Dealing with adverse effects  Access / availability of PUVA treatment in different parts of the country – some hospitals are now reducing or stopping their PUVA services.  Unlikely that the HTA would fund non UK centres because this is a common condition so recruitment should be able to be completed within the UK  Excluding contact dermatitis by Patch testing - not done everywhere and many hospitals have long waiting lists for patch tests (so may instead just exclude ‘active known’ contact dermatitis)  How long should the washout period from alitretinoin be? The drug has a long half-life and metablolites can be detected for up to 2 years. However, these are not clinically active metabolites in terms of drug efficacy, so 6 months was felt to be an appropriate washout period.  Genetic analysis – need to ensure this is kept to a minimum for HTA trials need to show that it is a pragmatic not exploratory study.  The use of NICE guidelines for trial entry (DLQI) may reduce the treatment costs for the trial (not research costs).  Patient education needs to be manualised  Site identification and feasibility needs to be done prior to the full application being submitted.  There needs to be two people available at each centre in order to perform the blinded outcome assessment. An alternative (or additionally as a back-up) could be photographs assessed by a central blinded assessor using a photographic assessment scale. M Wittmann welcomes more support from the UKDCTN and will forward documents to J Chalmers.  Trial Generation & Prioritisation Panel Update C Flohr presented a summary of the vignettes assessed by the panel over the last 12 months. Eight research proposals had been reviewed, one of which was the hand eczema study proposal presented today. The list included the acne research call last year when the acne priority setting exercise was funded with a £10k grant. Two proposals have since been withdrawn and the others are in different stages of development including: - a study on treatments for BCC led by John Lear. - a skin cancer prevention study proposed by F Cowdell and S Erser. F Cowdell agreed that the input from the panels had been very helpful. - a new proposal for a dosing study on cetirizine for chronic urticaria Trainee Day - Clinical Research skills The trainee day held in April was very well received. The training and hands on activity in working up a research proposal was designed to both generate new research ideas to go through the Network and adequately equip SpRs in the clinical research skills required by curriculum. Five groups were supported intensively by UKDCTN staff and previous SpR fellows to develop an idea to present at the training day. Most of the trainees are continuing to work on the study ideas, one of which has been submitted to the UKDCTN vitiligo themed call. The following comments were made:  Good to see that further work is continuing beyond the training day.  Research is part of the curriculum so good for SpRs to state they have taken part in this.  Attendees of the course could well be the future investigators for UKDCTN studies.  Suggestion for this to be held bi-annually. Next one in 2015.  Trials in Development Update C Layfield reported on the ongoing work of the network. Two priority setting partnerships underway- Hidradenitis Suppurativa and Acne. A Layton reported they had 1500 responses to their survey so far. It is on the NIHR portfolio as they intend on analysing the sub groups. She stated they have put useful documents on the NIHR portal.  Newly funded and Ongoing trials J Chalmers provided update on new and ongoing studies: - CLOTHES (specialist clothing for eczema) - BEEP (Prevention of eczema using emollients) - ELP STUDY (hELP) pilot study It is hoped this will start in Spring 2014 - C4C Cellulitis study (adopted – Dr R Brindle) - BLISTER – only 5 patients needed to reach target of 251! - STOP GAP - 121 patients. Recruitment closed.  Date of next meeting 12 November 2013 BAD offices London Further Information UK DCTN AGM Slides July 2013.pptx