Clinical trials
Clinical trials

The following Life Sciences practice note provides comprehensive and up to date legal information covering:

  • Clinical trials
  • The purpose of clinical trials
  • The clinical trial regulatory framework in the EU and its upcoming reform
  • Clinical Trials Regulation (CTR)
  • The clinical trial regulatory framework in the UK
  • The CTR and the Medicines and Medical Devices Bill
  • The scope of the Clinical Trials Directive
  • Clinical trials
  • Medicinal products
  • Non-interventional trials
  • More...

The purpose of clinical trials

A clinical trial is an investigation conducted in human subjects which aims to discover or verify the effects of and adverse reactions to a medicinal product, ie it assesses a medicine’s efficacy and safety. In the UK and the EU, clinical trials must be conducted on new medicinal products before they can receive approval to be placed on the market, but clinical trials are also conducted on medicinal products which are already available to the public in order to demonstrate their efficacy compared to competing products or placebos. For more information on marketing authorisations (MAs), see Practice Note: Marketing authorisations—regulatory procedures for approval of medicinal products.

The safety and protection of the human subjects is of paramount importance. Clinical trials on humans must be justified and can only take place after the long and detailed preclinical research process has concluded and the clinical trial has received the necessary authorisation.

A clinical trial may show that a new medicinal product improves patient outcomes, offers no therapeutic benefit, or causes unexpected harm. All of these results are important because they advance medical knowledge and help improve patient care. Due to the complex nature of clinical trials they usually last at least one year, generally involve numerous participants and several trial sites, often in different countries.

The clinical trial regulatory framework in the EU and its

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