Transparency in clinical research has been a long standing issue, especially when it comes to reporting results of completed studies. We previously took a quick look at two sources, ClinicalTrials.gov and Trialtrove®, to gauge the current state of results reporting. We found that only 27.5% of Phase III and 18% of Phase II interventional trials posted results to ClinicalTrials.gov. According to Trialtrove®, 66% and 63% of completed Phase III and II studies, respectively, reported results in journals or at medical conferences. Regardless of the data source, there’s still a lot of room for improvement (1).
At next month’s Pharma CI conference in New Jersey (2), I’ll present a more detailed analysis of the current state of clinical trial results reporting. The analysis looked at 7,425 Phase II-III, industry sponsored studies that completed their primary endpoints between January 1, 2008 and June 1, 2012. Again, results posted to ClinicalTrials.gov in addition to peer reviewed results found in journals and at conferences were considered. Besides overall reporting rates per trial phase, I also evaluated results reporting by industry sponsors and therapeutic areas. Here I’ll give a quick sneak peek of some data for the therapeutic areas covered by Trialtrove®.
When considering final and interim trial results found at ClinicalTrials.gov, published in a journal, or presented at a conference, the 8 therapeutic areas demonstrated reporting rates between 67.4%-89.7%. Oncology clearly leads the pack with some data on nearly 90% of completed trials. Second place goes to cardiovascular trials, which have results available for almost 80%. At the bottom are the smallest areas of genitourinary (67.4%) and ophthalmology (71.7%).
A different picture is painted when results are differentiated between final peer reviewed results and results posted to ClinicalTrials.gov. Oncology still leads when it comes to disclosing final peer reviewed results, however, oncology trials have the worst reporting rate for ClinicalTrials.gov results. Likewise, the ranking flips for genitourinary trials between the different source types. While genitourinary studies had the lowest % of studies with final peer reviewed results, they had the highest % of studies with ClinicalTrials.gov results. The results reporting rankings also shift for metabolic/endocrinology and infectious disease trials, but remain consistent for the remaining four therapeutic areas. So in order to get the full picture of results reporting, it’s clear that multiple sources need to be considered.
Stay tuned for more information on the overall reporting rates by phase and other details, or come see me speak on September 10th in Parsippany, New Jersey!