FAQ 4:

What steps are being taken to address the concerns of the publicly funded clinical trials community who fear that the transposition of this Directive could unnecessarily delay or stop trials

Key to Symbols

As well as submitting a very full response to the consultation, the MRC submitted an impact assessment to which CRUK and other funders and trialists contributed. This assessment identified six key issues for the MHRA, Government funders and trialists to address with a view to maintaining the UK’s record of success in publicly funded trials. The six areas were:

  1. The single sponsor model
  2. Excessive monitoring and pharmacovigilance
  3. Onerous trial and manufacturing authorisation and registration
  4. Transitional arrangements
  5. Trials in incapacitated adults
  6. Uncertainty about precise requirements and legal liability

MRC/DH joint project

THE MRC/DH joint project has explored each of these key issues to clarify how the current arrangements for non-commercial trials will be affected taking into account any flexibilities in the Directives, draft legislation and guidance. The project draws up practical guidance to enable those involved in publicly funded trials to comply with the new regulations and take advantage of those provisions that simplify the commencement and conduct of trials such as use of submission of applications and safety reports.

Authorisation for trials and manufacture

The transitional arrangements allow nearly all trials with current exemptions to roll over as “clinical trial authorisations” under the new legislation without submitting a new application or paying a fee. The arrangements are available on this and on the MHRA website.

Incapacitated adults

DH are exploring options for obtaining consent for incapacitated adults to enter a trial, including those eligible for research in emergency situations who may be unconscious. DH consulted on a draft guideline, met with stakeholders to explore the ethical and practical aspects of these situations and is reviewing proposals with lawyers.

Guidance on precise requirements and consideration of legal liabilities

The MHRA have prepared guidance to clarify the precise requirements of the legislation for sponsors and investigators conducting non commercial trials, including aids such as flow diagrams, algorithms and mock applications completed for different type of product and trial. Lastly, the DH/MRC project group has identified arrangements for sponsoring a trial, please see Sponsorship part of this website.