Developing a network in a neglected area of clinical research: the UK Dermatology Clinical Trials Network

Layfield, Carron; Clarke, Tessa; Kim, Thomas; Williams, Hywel C

doi:10.4155/cli.11.67

Cited by 8 publications

(7 citation statements)

References 3 publications

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“…This may be because the trials all addressed key questions that had been identified in previous systematic reviews [15][16][17][18] and prioritized by clinicians and patients through the UK DCTN. 19 Two of the UK DCTN trials in this survey [penicillin for recurrent cellulitis (PATCH) and doxycycline for pemphigoid (BLISTER)] dealt with inexpensive medicines that had been used for many years by some clinicians, which were thought to be beneficial but had never been tested properly. The SINS study was the first independent comparison of topical imiquimod against the reference standard of excisional surgery, which provided stable estimates of treatment responsean active comparison study that industry would not usually tackle.…”

Section: Discussionmentioning

confidence: 99%

Scoping the international impact from four independent national dermatology trials

et al. 2020

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Background. Research impact describes whether and how research results in wider benefits to society beyond academic publication. Little is known about translation of clinical trial research into dermatological practice. Aim. We scoped international impact from four independently funded clinical trials published by our group over the past 10 years. Methods. This was a scoping survey of 35 international colleagues from 22 countries followed by a narrative summary of emergent themes. Results. All recipients kindly responded to the survey. At least 20 emergent themes were identified, which broadly included: (i) interest and enthusiasm in the concept of trying to document clinical trial impact; (ii) direct impacts such as adoption of the drug as tested and recommended from the trial results, including more confidence using the drug in slightly different ways for the same condition; (iii) the finding that trial impact was dependent on factors such as drug availability and country-specific disease patterns; and (iv) the educational value of good trial design for journal club discussions and improving future clinical trial designs in dermatology. Our survey suggests that uptake into clinical practice was surprisingly rapid and widespread. Conclusion.Clinical trial research is of little use unless findings are translated into clinical practice for patient benefit. Our international scoping survey suggests that independent clinical trials that address important questions identified by the dermatology community have substantial, diverse and far-reaching impacts on dermatological practice.

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Section: Discussionmentioning

confidence: 99%

Scoping the international impact from four independent national dermatology trials

et al. 2020

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“…As the study is funded through a Doctoral Research Fellowship, investigators are contributing on a voluntary basis as they believe this is a clinically important question that will help to improve practice, and trial drugs are prescribed through normal clinical care pathways. This recruitment model has been successfully used in other UK Dermatology Clinical Trials Network Trials [ 21 ]. An example of a study previously developed in this way for a rare skin condition is the ‘STOP GAP’ trial of prednisolone versus cyclosporin for pyoderma gangrenosum [ 22 ].…”

Section: Discussionmentioning

confidence: 99%

Systemic therapy for vulval Erosive Lichen Planus (the ‘hELP’ trial): study protocol for a randomised controlled trial

Simpson

Murphy

Bratton

et al. 2016

Trials

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BackgroundErosive lichen planus affecting the vulva (ELPV) is a relatively rare, chronic condition causing painful raw areas in the vulvovaginal region. Symptoms are pain and burning, which impact upon daily living. There is paucity of evidence regarding therapy. A 2012 Cochrane systematic review found no randomised controlled trials (RCTs) in this field. Topically administered corticosteroids are the accepted first-line therapy: however, there is uncertainty as to which second-line treatments to use. Several systemic agents have been clinically noted to show promise for ELPV refractory to topically administered corticosteroids but there is no RCT evidence to support these. The ‘hELP’ study is a RCT with an internal pilot phase designed to provide high-quality evidence.Methods/DesignThe objective is to test whether systemic therapy in addition to standard topical therapy is a beneficial second-line treatment for ELPV. Adjunctive systemic therapies used are hydroxychloroquine, methotrexate, mycophenolate mofetil and prednisolone. Topical therapy plus a short course of prednisolone given orally is considered the comparator intervention. The trial is a four-armed, open-label, pragmatic RCT which uses a blinded independent clinical assessor. To provide 80 % power for each comparison, 96 participants are required in total. The pilot phase aims to recruit 40 participants.The primary clinical outcome is the proportion of patients achieving treatment success at 6 months. ‘Success’ is defined by a composite measure of Patient Global Assessment score of 0 or 1 on a 4-point scale plus improvement from baseline on clinical photographs scored by a clinician blinded to treatment allocation. Secondary clinical outcomes include 6-month assessment of: (1) Reduction in pain/soreness; (2) Global assessment of disease; (3) Response at other affected mucosal sites; (4) Hospital Anxiety and Depression Scale scores; (5) Sexual function; (6) Health-related quality of life using ‘Short Form 36’ and ‘Skindex-29’ questionnaires; (7) Days of topical steroid use; (8) Treatment satisfaction; (9) Discontinuation of medications due to treatment failure; (10) Per participant cost of intervention in each treatment group. Adverse events will also be reported.Discussion‘hELP’ is the first RCT to address second-line treatment of ELPV. The trial has encountered unique methodological challenges and has required collaborative efforts of the UK Dermatology Clinical Trials Network alongside expert clinicians.Trial registration: current controlled trialsISRCTN 81883379. Date of registration 12 June 2014.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-1133-z) contains supplementary material, which is available to authorized users.

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“…Additionally, the juxtaposition of the CSG alongside the UK Dermatology Clinical Trials Network (UKDCTN) at the Centre of Evidence Based Dermatology in Nottingham, UK, has led to new studies initiated by the UKDCTN on the basis of research gaps identified from CSG research. As an example, the current international clinical trial of tetracycline versus prednisolone for bullous pemphigoid arose from a Cochrane Review on this topic .…”

Section: Impactmentioning

confidence: 99%

The Cochrane Skin Group: a vanguard for developing and promoting evidence‐based dermatology

Reddi

Prescott

Doney

et al. 2013

J Evidence Based Medicine

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AimThe Cochrane Skin Group (CSG) is part of the international Cochrane Collaboration (http://www.cochrane.org/). The CSG prepares, maintains and disseminates high quality evidence‐based summaries on the prevention, diagnosis and treatment of skin diseases. We present a synopsis of the history, scope and priorities of the CSG. In addition, we report outcomes of CSG reviews and critically assess clinical value.MethodsDescriptive analysis of systematic reviews published by the CSG since its inception including output, impact factor, associated methodological studies, and influence in clinical guidelines, promoting patient and public engagement and in triggering new primary research.ResultsThe CSG started in 1997, and has published 61 reviews, 34 protocols and 31 registered titles by August 2013. The CSG scope includes 1000 skin diseases; 80% of reviews cover the top ten diagnoses and 40% of reviews provide clear guidance for clinical practice. CSG reviews had an impact factor of 6.1 in 2011 which places it alongside top dermatology journals. CSG reviews are typically broad in focus and have been shown to be of better quality than non‐Cochrane reviews. They are highly cited in clinical guidelines. Several reviews have identified evidence gaps that have led to better primary research.ConclusionsThe CSG has emerged as a vanguard of evidence‐based dermatology by growing a community interested in applying best external evidence to the care of skin patients and by identifying topics for research. CSG reviews are high impact, clinically relevant and have tangibly influenced international dermatology clinical practice guidelines and new research.

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Developing a network in a neglected area of clinical research: the UK Dermatology Clinical Trials Network

Cited by 8 publications

References 3 publications

Scoping the international impact from four independent national dermatology trials

Scoping the international impact from four independent national dermatology trials

Systemic therapy for vulval Erosive Lichen Planus (the ‘hELP’ trial): study protocol for a randomised controlled trial

The Cochrane Skin Group: a vanguard for developing and promoting evidence‐based dermatology

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