Most Publicly Available Clinical Trial Outcomes Are Incomplete: Study

As the debate over disclosing clinical trial data intensifies, a new study finds that publicly available sources do not contain the same detailed information about patient outcomes that can be found in the case study reports most drugmakers do not want to disclose. The study, which was published in PLoS Medicine, compared information available in CSRs with information in journals and registry reports.  The researchers found that unpublished CSRs included complete information for 86 percent of relevant patient outcomes, but the combined publicly available sources provided complete information for only 39 percent of the outcomes. The CSRs prepared for the trials in the study pool occurred between 1985 and 2010. The authors analyzed 101 trials with full CSRs for 16 health technology assessments of drugs completed between January 2006 and February 2011. The trials included nearly 70,000 patients and covered six different therapeutic areas – Type I and Type 2 diabetes, depression, asthma, stroke and Alzheimer’s. Of the 101 trials, 86 trials had at least one publicly available source, 65 at least one journal publication, and 50 had a registry report, or results database.  In addition, 36 percent of trials in the study pool were not published in journals, 15 percent had no publicly available records at all and even for trials with publicly available reports, 34 percent of patient-relevant outcomes were not reported. The trials included 1,080 patient-relevant outcomes. Symptoms...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs