Generating new evidence, improving clinical practice and developing research capacity: the benefits of recruiting to the U.K. Dermatology Clinical Trials Network's STOP GAP and BLISTER trials

Abstract

Clinical trials may benefit clinical practice in three ways: firstly, clinicians may change their practice according to the new trial evidence; secondly, clinical processes can improve when working on a trial; and thirdly, research capacity is increased. We held a meeting to present and discuss the results of two large multicentre randomized controlled trials delivered through the U.K. Dermatology Clinical Trials Network. Investigators gave reflections on how the trials had changed their clinical practice. The STOP GAP trial showed that prednisolone and ciclosporin are equally effective as first-line systemic treatment for pyoderma gangrenosum. The final decision of which treatment to use should be based on the different adverse event profiles of the two drugs in relation to comorbidities, along with age, disease severity and patient preference. The BLISTER trial showed that starting people with pemphigoid on doxycycline produces acceptable short-term effectiveness and a superior safety profile to oral corticosteroids. Recruiting to these trials has led to the development of new specialist clinics with improved documentation. It has increased the profile of participating departments and embedded research in the department's activities. Helping to design and run these trials has also allowed trial staff to develop new skills in research design, which has been beneficial for career development. These and other benefits of recruiting to the trials are summarized here. We hope that these reflections will inspire wider involvement in clinical research.

Scoring pyoderma gangrenosum

“…the STOP GAP trial) and reliable scoring systems (e.g. PARACELSUS score) are scarce . In this issue of the BJD , Jockenhöfer et al .…”

Participating in trials can inform better clinical practice

“…In their article in this issue of the BJD , Batchelor et al . describe the benefits of participation in clinical trials from the perspective of dermatologists who participated as investigators in two clinical trials . The STOP GAP trial assessed the relative efficacy of prednisolone vs. ciclosporin in the treatment of pyoderma gangrenosum, and the BLISTER trial assessed the effectiveness of doxycycline in the treatment of bullous pemphigoid .…”

“…Batchelor et al . describe aspects of clinical trial conduct that may help us enhance the care we give patients in the clinic . Seeing how helpful quantitative, formal assessments are for observing changes in disease severity may encourage us to incorporate such measures more often in clinical practice.…”

“…One of the investigators reported that participation led him to develop and use a standardized approach to assessing and documenting disease severity in the care of patients with pyoderma gangrenosum. This approach has facilitated the care of these patients; his outlook on caring for patients with pyoderma gangrenosum changed from dread to interest and challenge . I doubt than any lecture, article or book that suggested using such measures would have made him incorporate these new practices.…”