The British Journal of Urology International supports clinical trials. Plain. Simple. And with some new strategies

Randomized clinical trials (RCT’s) are the highest level of evidence‐based medicine. We know this to be true, but we also know that RCT’s are a challenge to fund, accrue patients, execute, and follow to endpoints. The late David Sackett described evidence‐based medicine as “…conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients.” From the statistician’s point of view, RCTs provide unbiased estimates of the effects of different treatments. From a clinician’s point of view, RCT’s provide the grandest of experiments in nature—a true test of option A versus option B. We are thrilled when one option beats the other. We can be satisfied if the options are equivalent, at least knowing the matter is settled and move on to the next question. Either way, the story lines can be rich with ongoing debate, drama, and analysis: were the cohorts truly equivalent? Was the study population generalizable? Were the treatments contemporary? Were there unintended harms/toxicities?

Allow us to illustrate some examples of what we propose to our readers. In 2003, Thompson et al [1] published the famous Prostate Cancer Prevention Trial in the New England Journal of Medicine: “The influence of finasteride on the development of prostate cancer.” This landmark study has been cited 2541 times, according to Google Scholar. Looking further at impact, one can go to the www.swog.org site and query the protocol “SWOG‐9217” and see that > 150 publications have been produced using this dataset (16 in 2016!). Several publications pre‐dated the primary endpoint paper and discussed trial design, the dilemma of chemoprevention, and updates to trial progress. Post primary endpoint, publications have looked at multiple strategies—costs, the high grade findings, longer term follow‐up, biopsy findings from the placebo arm, etc. Just last year, the U.K. made its mark on the prostate cancer world with the landmark ProtecT study [2]. Again, we see the primary endpoint paper in the NEJM, but secondary endpoint papers such as the quality of life outcomes are in BJUI [3], and a morality outcomes analysis for trial screen failures (Eur Urol 2017) [4].

BJUI can support clinical trial efforts through multiple pathways. Certainly, we would love to receive a primary endpoint paper from an important RCT in urology. We can also have impact by featuring important secondary endpoint papers, trial design papers (preferably ones that read like a good review article, with the trial proposed as the “answer” to the dilemma), as well as smaller/early phase I‐II trials that are stand‐alone pieces of key knowledge. Figure 1 shows a possible flow chart of a RCT with each box representing possible publication points. In addition to content in the BJUI, our webpage Blogs section has a “rapid response team” to start immediate dialogue on important RCT’s published in other journals. For example with the recent Yaxley trial [5] in the Lancet, our blogs section led by Declan Murphy had over 10,000 views and over 50 follow‐up comments. So clearly, our readers care about RCTs.

Figure 1.

A possible flow chart of a randomised clinical trial (RCT) with each box representing possible publication points. QOL, quality of life; f/u, follow-up.

Finally, BJUI can help with RCTs in two more ways. For the reader, we will highlight RCT related papers in their native sections (i.e. oncology, functional, education) with a special “Trials” headline, and will invite experts to comment on the significance of the study. For reviewers and authors, we will be critical on RCT design, such that flaws are identified, and papers not given inflated significance. Specific problem areas we see in peer review include allocation concealment errors (or not reported), and failure to adhere to 2010 CONSORT statement checklist for reporting RCTs. The CONSORT requirements are on our author submission guidelines, but ideally these are read and adhered to up front, as many are not possible to correct after the fact. Recently, we have also added that all RCTs must be registered (i.e. clinicaltrials.gov or similar) before the first patient is enrolled.