FAQs |
How are clinical trial participants to be protected under the Regulations?
The Regulations extend to academically led clinical research. Will this impose burdensome responsibilities on doctors who undertake trials?
The Council and European Parliament intended the Directive apply to non-commercial research; the recitals to the Directive specifically mention non-commercial clinical trials conducted by researchers without the participation of the pharmaceutical industry. Moreover those drafting the Directive and Commission guidelines constantly considered the impact on non-commercial research.
The purpose of the legislation is to protect clinical trial participants and to ensure that data generated from trials are accurate and verifiable. These issues are equally important, whether the research is commercially sponsored or publicly funded.