Julie Cooper – 2016 Parliamentary Question to the Department of Health
The below Parliamentary question was asked by Julie Cooper on 2016-01-21.
To ask the Secretary of State for Health, what measures and regulations are in place to ensure that clinical drug tests are low-risk and safe.
George Freeman
Clinical trials of medicinal products in the United Kingdom are strictly regulated by European Union and UK legislation in order to ensure that the studies achieve their scientific targets while safeguarding the trial participants. Before any trial of a new medicine is initiated in humans, the medicinal product will have undergone extensive non-clinical testing, both in the laboratory and in animals as appropriate. The organisation responsible for proposing the trial (the Sponsor) will submit a Clinical Trial Authorisation application that will be reviewed by both the Medicines and Healthcare products Regulatory Agency (MHRA) and a research ethics committee.
The MHRA assesses the safety and scientific value of the trial. A team of assessors will review the pharmaceutical quality of the medicinal product, the supporting data from pre-clinical testing and the details of the trial design and methodology, along with all available clinical data. The research ethics committee will ensure that the participant has been fully informed of all the necessary information about the trial, including information on potential risks and side effects.
All Phase I trials in healthy volunteers are assessed taking into account European guidelines on strategies to identify and mitigate risks for first in human (FIH) trials. In the UK, trials that are identified as being higher risk are referred by the MHRA to an Expert Advisory Group of the Commission on Human Medicines for advice.
The MHRA has instituted a Phase I accreditation scheme for organisations conducting phase I trials, in particular for those conducting FIH trials. MHRA Inspectors will grant Phase I accreditation only to those research units that exceed the basic regulatory Good Clinical Practice standards by having additional procedures that include the highest standards for avoiding harm to trial subjects and for handling any medical emergencies.
