Clinical Trials

Department of Health written question – answered on 27th January 2015.

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Photo of Rob Flello Rob Flello Labour, Stoke-on-Trent South

To ask the Secretary of State for Health, with reference to the Written Statements of 18 December 2013, Official Report, column 110WS and of 20 November 2014, WS14, and pursuant to the Answer of 20 November 2014 to Question 214789, what his policy is on the role of clinical trials in ensuring the safety and efficacy of innovative treatments; and what Departments are responsible for the regulation of such trials.

Photo of George Freeman George Freeman The Parliamentary Under-Secretary of State for Business, Innovation and Skills, The Parliamentary Under-Secretary of State for Health

The Medicines and Healthcare products Regulatory Agency is responsible for the regulation of clinical trials of medicinal products carried out under the Medicines for Human Use (Clinical Trials) Regulations 2004, which implements the Clinical Trials Directive 2001/20/EC. The Regulations do not cover innovative treatment services.

The Regulations define a clinical trial as:

“clinical trial” means any investigation in human subjects, other than a non-interventional trial, intended—

(a) to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products,

(b) to identify any adverse reactions to one or more such products, or

(c) to study absorption, distribution, metabolism and excretion of one or more such products, with the object of ascertaining the safety or efficacy of those products.

Clinical studies of certain treatments may fall within the remit of other regulators but that will depend on the nature of the study.

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