Most clinical trials run by small companies are missing results

1 Nov 2019

While large pharmaceutical companies typically do well at making clinical trial results public on registries, many small companies still fall short of minimum regulatory standards.

 

The data below shows clinical trial reporting performance in the EU and US broken down by sponsor type:

  • In Europe, 66% of trials run by small companies are missing results, versus 76% of trials run by universities and other non-commercial research institutions.

  • In the United States, where many major universities have put into place strong trial reporting systems, even medium sized companies perform worse than non-commercial trial sponsors at posting trial results.

 

Europe: 66% of trials by small companies are missing results

 

United States: 72% of trials by small companies missing results

 

 

Reporting rates for all trials, i.e. including trials not underlying regulatory requirements, are presumably lower, but no comprehensive performance data set exists (yet).

 

The data above is limited to those trials that fall under regulatory reporting requirements, and thus does not cover all trials.

  • In the case of European trials, this includes all trials listed on the EUCTR trial registry run by the European Medicines Agency, but excludes all trials not listed on EUCRT, such as trials of medical devices and non-drug treatments.

  • In the case of US trials, it is limited to trials that fall under the FDA Amendments Act's reporting requirements.

 

According to World Health Organisation standards, every interventional clinical trial should post its summary results onto every registry where it was originally registered within 12 months of trial completion.

 

EU and US regulations also set out a 12 month reporting timeframe, but do not cover all trials.


 

Note: The data cited above was provided by Thomas Wicks of TrialScope, a clinical trial disclosure company providing services to the pharmaceutical industry. TranspariMED did not independently check the data. The methodology for assessing EUCTR results posting performance differs slightly from that used by the widely cited EU Trials Tracker; it identifies more trials as due to post results because it uses data from Clinicaltrials.gov to backfill missing completion dates on EUCTR. TranspariMED would like to thank Thomas Wicks for permission to reproduce his findings here.

 

 

Share on Facebook
Share on Twitter
Please reload

Subscribe
Subscribe
Recent Posts
Please reload

This site was designed with the
.com
website builder. Create your website today.
Start Now