News

NETSCC publishes a pilot evaluation of the draft MHRA risk-adapted approaches guidance

20 September 2011

NETSCC has published the results of a pilot evaluation examining the draft Medicines and Healthcare products Regulatory Agency (MHRA) guidance on risk-adapted approaches to the management of clinical trials of investigational products.

The evaluation was conducted earlier this year following a request from the MHRA to provide comment on draft documents.  Participants included several on-going NIHR HTA and EME programme clinical trials, Clinical Trials Units and NHS Trust R&D Offices. 

The majority of participants thought the MHRA guidance was valuable and timely.  However some concern was expressed about the overall process, in particular in terms of the length, complexity and clarity.  Recommendations for modifying the approach typically focused on the need for greater clarity and improved structure.
The report has been passed to the MHRA who will use these findings in considering refinements and amendments to the guidance.  It is expected that the revised guidance will be published by the end of September 2011.  For more information – please consult the MHRA website www.mhra.gov.uk

NETSCC has been pleased to assist the MHRA in developing the guidance resource on risk-adapted approaches.  The implementation of risk adaption on the conduct of trials is an important development and will impact on the conduct and delivery of non-commercial trials, and it is hoped help to reduce some of the current issues faced by NIHR-funded researchers.

A copy of the pilot report can be downloaded here

Notes for editors:

The concept of risk adaptation was implemented by the MHRA for UK trials on the 1st April 2011.  Information about risk adaptation, which was the outcome of a risk-stratification project initiated by an ad-hoc working group under the auspices of Department of Health, MHRA and Medical Research Council, can be found in the following paper:
www.mhra.gov.uk/home/groups/l-ctu/documents/websiteresources/con111784.pdf

The risk adaptation approach implements a trial notification process and details of this can be found on the following page:
http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Clinicaltrials/
Submittinganotificationforatrial/index.htm