Getting involved
- If you or your child are getting involved in a clinical trial, please visit the following website http://www.nhlbi.nih.gov/childrenandclinicalstudies/index.php. It provides clear information on
- Getting Started In a Study: Information on the research team, what you might need to ask, and what role kids play in participating. Includes a list of possible questions you might want to consider asking your research team.
- Importance of Research In Kids: Why is research important, how is it different from regular care, safety and protections, are there benefits, your right to say no, minority interests and questions
- Once In a Study: Information on how studies affect the family and what kids think, what happens if you leave a study or what happens when it ends
- Resources: Know what rights you have, where to find information, and terms that you may hear in a study
- Getting Started In a Study: Information on the research team, what you might need to ask, and what role kids play in participating. Includes a list of possible questions you might want to consider asking your research team.
- Paediatric clinical trials
All clinical trials performed in the European Union are registered in a database called EudraCT. This database will now include all trials performed anywhere in the world with children, if the trial is part of a paediatric investigation plan.
EudraCT was previously not accessible to the public. However, Article 41 of the Paediatric Regulation (Regulation (EC) No 1901/2006) provides the legal basis for publication of information on paediatric clinical trials entered in this database.
The Regulation also stipulates that details of the results of paediatric clinical trials, including those terminated prematurely, have to be made public by the EMEA from now on.