FAQs

The Directive and the implementing UK Regulations cover only investigations/studies which are undertaken to ascertain the efficacy or safety of a medicine in human subjects. Non-interventional trials are excluded from the Regulations. To classify a trial as non-interventional, it must meet all of the following criteria:

• are studies involving products with a marketing authorisation that are prescribed in the usual manner and used in accordance with the authorisation;
• when the patient is assigned to a therapeutic strategy within current practice and not according to a protocol;
• the diagnostic or monitoring procedures are only those ordinarily applied to the therapeutic strategy;
• and epidemiological methods are used to analyse the data.

(See the Regulations for a precise definition.)

If a study is not for the purpose of ascertaining the effects of or reactions to a product and the product is simply being used as an aid or tool in the study, it is not a clinical trial covered by the Regulations. For example, inhttp://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=101 the case of the study of blood flow involving the infusion of vasoactive substances, if the purpose of the study is to monitor the effects of a particular substance to see if it is effective in achieving a particular physiological effect, then it is not a clinical trial. If the infusion is for the purpose of modifying the rate of flow for a therapeutic indication such as claudication, it would be deemed a trial under the Directive as the purpose of the study is to establish the efficacy of a particular medicine.

MHRA have released an algorithm to help clarify which trials fall under the scope of the Regulations.