Results of many clinical trials done in the European Union since 1st May 2004 will soon have to be posted to an online database.
When a person or company wants to run a clinical trial on a medicine in the European Union (or one involving children in other countries) they must submit their application using the European Clinical Trials Database (EudraCT). This database is used by governments to monitor clinical trials and ensure the safety of the patients involved. Some of the information in the database is made public through the European Clinical Trials Register.
Starting on 21st July 2014, people who have registered a clinical trial in EudraCT will have to add the results of their trial. The time limit on posting trial results depends on the trial:
- Clinical trials that ended before 21st July 2013 will have to report their results by 21st July 2015.
- Clinical trials that ended between 21st July 2013 and 21st July 2014 will have to report their results by 21st July 2014.
- Clinical trials involving adults that end after 21st July 2014 will have to report results within one year of the end of the trial.
- Clinical trials involving children that end after 21st July 2014 will have to report results within six months.
This means that a summary of results – including information on the study objectives, its design and its main results and conclusions – will soon be made public for many clinical trials.