Randomized controlled trials in urologic oncology: a demographic analysis

We examined randomized controlled trials in urologic oncology published in 1992. Particular emphasis was placed on the contribution of urologists and studies with a surgical arm. Randomized controlled trials in bladder, prostate, testis and renal carcinoma were identified by a structured MEDLINE search. Results were analyzed to determine modality of treatment, disease site, principal author, country of origin, cohort size, number of participating centers, source of funding and type of journal. MEDLINE retrieved 162 references of which 126 were excluded by title (10), abstracts (105) or articles (11) as not urologic oncology (7) or not a randomized controlled trials (119). Of the qualifying 36 randomized controlled trials, the site of the disease was bladder (44%), prostate (39%) renal (14%) and testis (3%). All except six randomized controlled trials compared medical therapies. Only five had a surgical arm and one had a radiation arm. Cohort size was > 100 in 67% of randomized controlled trials with most (56%) being multicenter trials. Participating countries were Europe, excluding the UK (35%), the US (23%), Japan (20%), Canada (13%), and the UK (10%). Urologists were the principal authors of 67% of the papers describing randomized controlled trials. The majority of trials were published in nonsurgical journals (50%). Funding for randomized controlled trials was from government (28%), pharmaceutical companies (19%), private sources (3%) and not stated (50%). Although randomized controlled trials are being conducted in urologic oncology, there are relatively few compared with trials using inferior study designs. A still smaller proportion of randomized controlled trials contain a surgical arm.