Publicly available sources provide insufficient information on patient-relevant outcomes of clinical trials09/10/2013
Beate Wieseler and her colleagues compared the information available in unpublished 101 clinical study reports (CSRs) with information presented in publically available sources for these trials. The CSRs provided complete information on a considerably higher proportion of outcomes (86%) than the combined publicly available sources (39%). With the exception of health-related quality of life (57%), CSRs provided complete information on 78% to 100% of the various benefit outcomes (combined publicly available sources: 20% to 53%). CSRs also provided considerably more information on harms. The differences in completeness of information for patient-relevant outcomes between CSRs and journal publications or registry reports (or a combination of both) were statistically significant for all types of outcomes.