Late Protocol Registrations
Sponsors continue to struggle with the challenges of meeting global clinical trial disclosure deadlines. The TrialScope team conducted a summary analysis of late protocol registrations by sponsor type from available data on clinicaltrials.gov.
Sponsors continue to struggle with the challenges of meeting global clinical trial registration and disclosure deadlines. The TrialScope team conducted a summary analysis of late protocol registrations by sponsor type from available data on clinicaltrials.gov. We broke sponsors into 3 categories: 1) academia = other, 2) industry = life sciences companies and 3) PharmaCM customers. We looked at protocol registrations that were done more than 21 days after study start. As the graphic below indicates, PharmaCM customers were 6 times more compliant than their industry peers in 2014!
The graphic also illustrates:
- The industry is generally making modest improvements toward compliant clinical trial registrations.
- Academia is also making modest improvements though their metrics are generally higher than those of life sciences companies.
- There is still a great deal of room for improvement.
TrialScope will be introducing a Clinical Trial Transparency Maturity Model that you will hear more about shortly. This model will help sponsors to take a look at their own systems, processess and standards to assess their overall capabilities compared to those of their industry peers. This type of measurement tool helps companies implement process improvements that lead to greater efficiencies. However, on a broader scale, it also helps teams to focus on high priority issues that may impact risks of non-compliance and can help sponsors meet their compliance objectves.
If you would like to learn more about the Clinical Trial Maturity Model, please contact Thomas Wicks at Thomas@TrialScopeinc.com.
Download our white paper: Introduction to Clinical Trial Disclosure.
See also our related blog: Introduction to Clinical Trial Disclosure