Clinical Trials

A number of steps have to be followed before a trial can begin, the first of which is to confirm whether or not the trial falls within the scope of the UK Medicines for Human Use (Clinical Trials) Regulations 2004 which implement the EU Clinical Trials Directive in the UK. If it does, then the trial protocol should be written and funding sought, if required, with the Regulations in mind.

The Medicines and Healthcare products Regulatory Agency (MHRA) has produced an algorithm to help researchers determine if their study falls within the scope of the Directive.

A sponsor must be identified and a EudraCT number obtained, followed by authorisation from the MHRA (Clinical Trial Authorisation) and approval by an Ethics Committee.

These applications should be made through the Integrated Research Application System (IRAS) and guidance on how they should be made is available on the IRAS site. The IRAS site offers a training module on the system to support the use of IRAS.

Trust research (R&D) approval is also required before a trial can start in any clinical site.  These steps can be done in parallel.

Trials that are outside the scope of the UK Regulations must still comply with the NHS Research Governance Framework. A Sponsor must be identified and approval obtained from an Ethics Committee and relevant NHS R&D departments.

Once you have established your trial falls within these Regulations you will find the Clinical Trials Toolkit website helpful. This tool kit was launched to bring together and disseminate the work of the MRC/DoH Joint Project established to address a range of important issues raised about the implementation of the requirements of the UK Medicines for Human Use (Clinical Trials) Regulations 2004. The site has been developed primarily for clinical trialists and R&D managers working in the academic sector, but will also be of use to other health professionals.

Much of the advice contained in the tool kit is organised in the form of three route maps.

• The first route map considers the transitional arrangements for trials which began recruitment before the legislation came into force in the UK.
• The second is designed for those planning a new trial and this route map takes them through the planning process from an initial research question to obtaining all the relevant permissions and approvals required to conduct the study.
• The third looks at the trial from recruitment to data archiving.

When a visitor clicks on a station of the road map they are taken to a description of the process and a list of relevant resources. Some stations have a sub map. Each map identifies statutory requirements in red and good practice in blue.