Randomized controlled trials in testicular cancer: A demographic and quality assessment

Randomized controlled trials (RCT) provide the strongest evidence to justify interventions in patients. However, trials with inadequate methods are associated with bias and exaggerated treatment effects. A search of the literature was conducted to review RCTs in testicular cancer (TC) to assess demographic and trial reporting quality patterns over time.

MEDLINE and CENTRAL were queried for TC RCTs from 1989 to 2014. Demographic information was abstracted and reporting quality score was evaluated using the Consolidated Standards of Reporting Trials criteria. Linear regression was used to assess the trend in reporting quality over time.

A total of 39 RCTs were identified, of which 25 were published from 1989 to 2001 and 14 were published from 2002 to 2014. Most (59%) of the RCTs involved chemotherapy as the intervention, had a medical oncologist as the first author (87%), and took place in Europe (59%). RCTs published between 2002 and 2014 had longer enrollment periods (mean = 6.1 [2.7] vs. 3.7 [1.5] years, P = 0.007), whereas the number of patients randomized, median follow-up, or time from manuscript submission to acceptance were not significantly different between the periods. For each increasing year of publication, there was a significant improvement of 1.34% points (95% CI: 0.86-1.83, P<0.0001) in the Consolidated Standards of Reporting Trials score.

Fewer RCTs in TC were published in the recent 13-year period. Although the quality of trial reporting improved compared with the preceding 13-year period, deficiencies remain. Urologists can play an important role in trial design, recruitment, and execution, and ensuring trial methodology and reporting quality is prioritized.