Clinical trials in the <i>BJD</i> : reviewing the last decade and looking to the future
Authors: J.M. Batchelor
Journal: British Journal of Dermatology (2020)

Clinical trials are at the heart of the BJD.1 For the last 10 years I have worked on the BJD editorial team as section editor for clinical trials, and the time has come for me to hand the role over to someone else. This offers the ideal opportunity to reflect on the progress we have made, and to look ahead to how we aim to develop this strand of the BJD's work in the future. Clinical trials represent a substantial proportion of the most highly cited and downloaded articles published by the BJD. In the last 10 years, the majority of the most highly cited and downloaded clinical trials have been those assessing the use of biologic agents for psoriasis and eczema,2 but trials assessing other treatments, such as topical treatments for photoageing,3 have also been in the top 100 most downloaded articles. The BJD has also led the way in publishing Priority Setting Partnerships,4 which identify research gaps that need to be addressed by future clinical trials. Clinical trials have a ‘second life’ when they are incorporated into systematic reviews and guidelines, and it is pleasing to see that many clinical trials published in the BJD have been used to shape clinical practice in this way. Many have been incorporated into the British Association of Dermatologists (BAD) clinical guidelines, such as the 2018 BAD and British Photodermatology Group guidelines for topical photodynamic therapy.5 Guidelines produced by other organizations are also informed by clinical trials that have been published in the BJD, such as the 2016 American Academy of Dermatology's guidelines of care for the management of acne vulgaris.6 For manuscripts reporting clinical trials, probably the most important change we have introduced at the BJD over the last 10 years is mandatory trial registration.7 Although in the past the BJD made authors aware that prospective registration of trials was good practice, it was not a mandatory requirement.8 We first proposed mandatory prospective registration in 2014, announcing the beginning of a 1-year amnesty period, after which we insisted on prospective registration for all clinical trials published in the BJD. Prospective registration is essential to allow full and transparent assessment of clinical trials, ensuring that there has been no selective reporting of trial outcomes, which could lead to bias in the interpretation of trial results.9 Clinical trials often take many years to design and deliver, so there has inevitably been a time lag between introducing mandatory trial registration in 2015, when the majority of clinical trial submissions were not meeting this requirement, and the present day, where the majority do. We will continue to insist on mandatory registration of all clinical trials submitted to the BJD. In our experience, prospective registration of a clinical trial is often a surrogate marker for other aspects of high-quality reporting of clinical trials, especially adherence to CONSORT reporting guidance. Most of the high-impact dermatology journals now insist that clinical trial manuscripts follow CONSORT, and the BJD was an early adopter.10 Twenty years ago, the quality of reporting of clinical trials in dermatology journals was poor.11 The adoption of CONSORT by journals has led to marked improvements in reporting quality, and recent literature reviews have shown that the BJD leads the way in this.12 However, there is still progress to be made and we will strive to improve further the quality of reporting of clinical trials published in the BJD. Sometimes the results of clinical trials are not quite what the authors hoped. In particular, the trial might not show that a new treatment is any better than those currently available; in other words, what is commonly referred to as a ‘negative’ trial. However, publication of such trials is every bit as important as publishing those that show dramatic differences between the treatments being tested. All clinical trials need to be published, or at the very least the results made freely available, so that all of the data available on specific treatments can be considered in their entirety. If trials demonstrating statistically or clinically nonsignificant differences between treatments are not published (i.e. publication bias), this is a waste of research resources and can distort the scientific record.13 For this reason, at the BJD we are keen to receive manuscripts reporting high-quality trials with statistically or clinically nonsignificant findings.14 At the BJD we have championed publishing both primary and secondary outcomes in the same manuscript, or in separate manuscripts that are published alongside each other in the same issue of the journal. The only exception is secondary outcomes that are not yet available due to a long trial period. This is important because it allows all outcomes for a clinical trial to be considered in their proper context, without the need to refer back to another paper published elsewhere. There are many possible reasons for publishing primary and secondary outcomes separately, which might include the desire to publish the primary outcome in a very high-impact general medical journal or increasing the potential readership for a trial by publishing different outcomes in separate journals. We argue that it is never necessary on grounds of space, because supplementary material can be posted online in the BJD in order to minimize the length of the manuscript.15 Indeed, with careful writing it can be possible to report a randomized controlled trial in a research letter format (which we sometimes suggest), while still meeting CONSORT reporting requirements;16 sometimes less is more! We will continue to advocate for the publication of all outcomes from a trial in one place, to aid their interpretation and to avoid wasting journal space and the time of editors and peer reviewers. Speaking of peer reviewers, our editorial team are greatly indebted to those who give up their valuable time to peer review manuscripts submitted to the BJD. Without them we could not function. Thank you to all of you who have helped to review clinical trial manuscripts for our team; a good-quality peer review of a manuscript truly can be, in the words of a colleague, wonderful to behold!17 One exciting new initiative that we have recently introduced at the BJD is ‘fast track’ peer review of important clinical trial manuscripts that are particularly time sensitive or that have significant potential to change clinical practice. Approval for fast track is entirely at the discretion of the Editor. A presubmission enquiry must be made at least 3 weeks before submission. The enquiry should include the abstract of the article and the reason for requesting fast track. Please send enquiries to the Editor at bjd@bad.org.uk. Once a paper is approved for fast track, authors must specify a submission date, allowing the journal to prepare reviewers. We aim to give a first decision on fast-track papers within seven working days. Revisions will also be handled swiftly. There is no charge for the fast-track service and enquiries from industry and academic contributors are encouraged. Finally, I am delighted to be handing over the role of clinical trials section editor to Dr Aaron Drucker. He has already established himself as a very valuable member of the BJD editorial team and has extensive first-hand experience of clinical trials and other aspects of evidence-based medicine.18 I am sure that this strand of the BJD's work will continue to flourish under his guidance. I would like to thank all of the members of the BJD clinical trials editorial team. They have been full of great new ideas and are a truly inspirational group of people to work with. Thank you to Joerg Albrecht, Aaron Drucker, Gudula Kirtschig, Antonia Lloyd-Lavery, Rubeta Matin, Mahtab Samimi, Rosalind Simpson and Emma Veysey. Thank you to former BJD editor Tanya Bleiker for inviting me to join the editorial team in 2010, to her successors Alex Anstey and John Ingram for giving me free rein to develop the clinical trials section, and to all those in the BJD editorial office and at Wiley, for supporting our work. Finally, thank you to Professor Hywel Williams and Professor Kim Thomas for teaching me the essential skills of critical appraisal and mentoring me in my own work on clinical trials.