Guidance

Clinical trials applications for Coronavirus (COVID-19)

The MHRA is ready to prioritise and provide any assistance for clinical trials applications submitted for COVID-19

Prioritising COVID-19 assessments

We have procedures for rapid scientific advice, reviews and approvals and are ready to support manufactures, researchers and other regulators. We have dedicated resources to ensure this happens, as we did during the Ebola crisis when we authorised clinical trial applications within a week.

Submitting COVID-19 applications

Please submit any applications directly to the Clinical Trial Helpline by emailing clintrialhelpline@mhra.gov.uk, as well as through the normal CESP route so we can begin work as soon as possible. We will then liaise closely with any applicants to ensure it’s managed as efficiently as possible.

If you want advice of any aspect of a clinical trial, call or email our Clinical Trials Unit on clintrialhelpline@mhra.gov.uk or 020 3080 6456.

You can also contact the HRA who can advise on expedited Ethics Committee opinion.

Naming your study

As requested by the WHO, please ensure that the WHO official acronym for the coronavirus disease (COVID-19) is entered in the title field of the trial registration data set (Annex 1 XML). This will facilitate finding and extracting clinical trials related to COVID-19 from public databases.

Participating in COVID-19 clinical trials

The MHRA does not get involved in deciding whether someone is eligible to participate in a clinical trial.

Please do not contact the MHRA for information about COVID-19 trials and whether or not you can take part.

We strongly recommended that you access the resources listed below. If you have any additional questions related specifically to your own health, you should discuss these with your General Practitioner or other healthcare provider.

Any COVID-19 trials that are open for enrolment should be registered on a public site and you may wish to search these websites:

This is where you can access all of the information that is publicly available.

We have separate guidance on Managing clinical trials during Coronavirus (COVID-19).

Published 19 March 2020