FOI release

FOI 21/083 – Number of Non-Oncology Indication Studies (Phase 1 & First time in Human), 2018, 2019, 2020

Published 24 March 2021

Thank you for your information request, dated 25th January 2021, where you asked for:

  • Total number of Phase I studies in non-oncology indications for 2018, 2019 and 2020

  • Total number of First-time-in Human Studies for non-oncology indications for 2018, 2019 and 2020

I am pleased to provide you with the information requested, see below.

Phase I studies* in Non-Oncology indications

2018: 173

2019: 110

2020: 111

First Time in Human studies for Non-Oncology indications

2018: 56

2019: 36

2020: 86

NB – Studies related to cancer pain, nausea etc are included in the Non-Oncology count.

*This data includes only ‘pure’ Phase I studies as determined by the MHRA.

The Freedom of Information Act only entitles you to access to information – the information supplied is subject to Crown copyright, and there are some restrictions on its re-use. For information on the reproduction or re-use of MHRA information, please visit https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information.

If you have a query about the information provided, please reply to this email.

If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk

Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

Yours sincerely

Licencing Division

Clinical Trials Unit

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU Telephone 0203 080 6000