UK Initiative on Rapid Patient Access to COVID-19 Treatments

As part of the collective response to COVID-19, a significant number of clinical trials are underway in an attempt to identify potentially effective COVID-19 treatments and bring them rapidly to patients. The EMA has published guidance documents on EMA initiatives for the acceleration of development support and evaluation procedures for COVID-19 treatments and vaccines

In the UK, NIHR, NICE, NHSE&I and the MHRA have been working closely together under the banner of the RAPID-C19 initiative to support this effort.

RAPID-C19 aims to ensure that there is a rapid, systematic and collective approach to taking promising medicines from those clinical trials through existing processes to enable rapid patient access – the goal being that this coordinated approach will take no longer than ten days from the receipt of the clinical trial evidence for treatments of significant clinical value. The scope of the RAPID-C19 initiative is for new and repurposed medicines that could significantly improve the treatment of COVID-19 patients.

The various steps to coordinate the collective work can be summarised as:

• Collective, proactive identification of clinical trials with significant promise (national and international), led by NIHR and NICE
• Collective prioritisation of timely/promising trials to be collectively fast-tracked, through the Oversight Group,  which meets weekly
• Agreeing and then organisationally supporting the appropriate ‘routing’ of priority treatments through existing processes (such as EAMS, NHSE Interim Commissioning policies, licence through MHRA etc.).

It is important to note that the partner organisations are seeking to fast track medicines of promise through the existing process but at pace. As such, the collective RAPID-C19 Oversight Group is NOT acting as a decision-making body but as a project oversight/directing group, ensuring all necessary elements are on track and meet individual organisational (i.e. MHRA) process requirements.