Is the timely publication of clinical trial results a reality?
The push for transparency of clinical trial data has gathered momentum over recent years. The World Health Organization (WHO) has called for journal submission of trial results within one year of study completion, and publication within 2 years. The International Federation of Pharmaceutical Manufacturers has pledged to publish all Phase III data and any clinically significant results irrespective of outcome. Good Publication Practice guidelines (GPP3) call for the submission of all clinical studies relating to licensed products within 12 months of study completion if possible (preferably in a peer-reviewed journal).
In response, Pfizer has conducted an investigation into all Pfizer sponsored clinical studies that completed in 2010 and involved Pfizer prescription products. The proportion of published studies and the median time to publication were evaluated. The analysis found that 85% of studies had been published, and the median time to publication was 31 months. Only two studies had not yet been submitted and seven were not going to be published as they were considered of limited value due to recruitment difficulties resulting in early termination, although data are available on ClinicalTrials.gov. Journal rejection of manuscripts (more than 50% of articles were rejected at least once) contributed to the publication time delay. Other factors that may have resulted in a delay included liaising with multiple authors in different time zones and with different priorities, and unsuitable journal selection.
The results observed were comparable to other published studies. The authors of the article call for the industry as a whole (authors, sponsors and editors) to come together and explore ways to streamline the publication process in order to comply with the timeframes outlined by the WHO and GPP3.
Summary by Jo Chapman, PhD from Aspire Scientific.
I do wonder about the 12-month time frame for full publication. It takes 90 days to get a solid CSR after LPLV (I read that in the EMWA journal somewhere, but would be happy to have a CRO comment) then about 23 weeks for a reasonably smooth manuscript to get to submittable state (assuming everyone comments when they’re supposed to and things go as expected, of course), so that only leaves about 3 months for journal editorial assessment, peer review, turning around comments (again, with all the appropriate approvals) and proofs. So if your authors are realistic enough to pick an appropriate journal, everyone behaves in terms of turnaround times and your peer reviewers are willing and able to comment in a timely fashion, it might be achievable.. But in the real world?