Guide to COVID-19 clinical evidence generation launched by NIHR and NICE
The NIHR and NICE have developed a guide on clinical evidence generation for developers of medicinal products for COVID-19. The aim is to promote the highest standards possible within the constraints of the pandemic in terms of registration, conduct and reporting of studies, so that research on new treatments can be translated into clinical practice as fast as possible.
The guide covers both confirmatory trials and real-world evidence collection on disease treatment and prevention, outlining the best practice approaches to a range of issues including trial design, population identification, the length of the trial and trial outcomes. It should be read in conjunction with the NICE guide to the methods of technology appraisals 2013.
Professor Hywel Williams, Director of the NIHR Health Technology Assessment Programme, who contributed to the guide, said:
“The COVID-19 pandemic has required researchers to radically alter the pace of their work. In the rush to produce something, there is a temptation to discard some of the basic principles of good study design which will limit the usefulness of the research. For example, using core outcome measures for trials will help in pooling similar studies together in order to make better sense of the totality of evidence.
“This joint guide will help ensure that research is done well and standardised so that it can benefit patients as quickly and safely as possible, and is a good example of how the UK is leading work in this area.”