Clinical Trials

Health written question – answered on 8th May 2014.

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Photo of Andrew Gwynne Andrew Gwynne Shadow Minister (Health)

To ask the Secretary of State for Health what guidance his Department publishes for pharmaceutical companies to ensure that the clinical trials they conduct are carried out ethically and safely.

Photo of Daniel Poulter Daniel Poulter The Parliamentary Under-Secretary of State for Health

The International Conference on Harmonisation (ICH) Note for Guidance on Good Clinical Practice (GCP) is an international standard for GCP. It became operational in the European Union in January 1997 and is a set of internationally recognised ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects. This guidance is available on the web and is published on the Medicines and Healthcare products Regulatory Agency’s (MHRA) website. In addition the MHRA published the MHRA Good Clinical Practice Guide in September 2013.

The Health Research Authority (HRA) publishes a range of resources on research ethics that have relevance to clinical trials sponsored by pharmaceutical companies. These resources are available on the HRA website at:

www.hra.nhs.uk/resources/

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