Context Randomized trials with adequate sample size offer an opportunity to
assess the safety of new medications in a controlled setting; however, generalizable
data on drug safety reporting are sparse.
Objective To scrutinize the completeness of safety reporting in randomized trials.
Design, Setting, and Patients Survey of safety reporting in 192 randomized drug trials 7 diverse topics
with sample sizes of at least 100 patients and at least 50 patients in a study
arm (N = 130074 patients). Trial reports were identified from comprehensive
meta-analyses in 7 medical areas.
Main Outcome Measures Adequate reporting of specific adverse effects and frequency and reasons
for withdrawals due to toxic effects; article space allocated to safety reporting
and predictors of such reporting.
Results Severity of clinical adverse effects and laboratory-determined toxicity
was adequately defined in only 39% and 29% of trial reports, respectively.
Only 46% of trials stated the frequency of specific reasons for discontinuation
of study treatment due to toxicity. For these 3 parameters, there was significant
heterogeneity in rates of adequate reporting across topics (P = .003, P<.001, and P = .02, respectively). Overall, the median space allocated to safety
results was 0.3 page. A similar amount of space was devoted to contributor
names and affiliations (P = .16). On average, the
percentage of space devoted to safety in the results section was 9.3% larger
in trials involving dose comparisons than in those that did not (P<.001) and 3.8% smaller in trials reporting statistically significant
results for efficacy outcomes (P = .047).
Conclusions The quality and quantity of safety reporting vary across medical areas,
study designs, and settings but they are largely inadequate. Current standards
for safety reporting in randomized trials should be revised to address this