Guidance issued for developers of medicinal products for COVID-19

NICE and the NIHR have published advice on clinical evidence generation for the developers of medicinal products to prevent or treat COVID 19.

The guidance is intended to be read in conjunction with relevant regulatory guidance documents and the NICE guide to the methods of technology appraisals 2013. Its recommendations provide general advice on the design and conduct of clinical data collection in the treatment and prevention of COVID-19.

The document features advice on the following aspect of clinical trials:

  • design
  • population
  • intervention
  • comparator
  • background therapy
  • outcomes
  • duration
  • reporting.

Sponsors of clinical trials are encouraged to engage with NICE to obtain fast-track scientific advice on the design of their studies as early as possible. Joint regulatory and health technology assessment scientific advice with NICE and the Medicines and Healthcare products Regulatory Agency should be considered. If studies are to be conducted in the UK, it is recommended that sponsors of clinical trials get in touch with the NIHR Study Support Service.