The National Institute for Health and Care Excellence (NICE) and the National Institute for Health Research (NIHR) have launched a guide on clinical evidence generation for developers of COVID-19 medicinal products.
The aim of the guide, which is the first joint document of its kind produced by the two organisations, is to set out best practice for conducting research whilst being mindful of the challenges associated with this during the COVID-19 pandemic.
The guide, which is free to access from the NICE website, provides advice on what developers of medicinal products need to consider, including clinical trial design, the trial population, the length of the trial, trial outcomes and real-world evidence collection. The guide now also includes a new section on prevention studies.
Alongside the launch of the guide, NICE Scientific Advice has also been providing free fast-track advice for researchers who are developing novel diagnostics or therapeutics for COVID-19. If the developer has a study planned, the NICE Scientific Advice team has committed to reviewing the proposed study protocol within three weeks, and will conduct a two-hour virtual meeting to discuss its report.
It also comes as the European Medicines Agency highlights the importance of high-quality observational studies of real-world data collected during the pandemic alongside the results of randomised clinical trials to provide evidence on the safety and effectiveness of vaccines and treatments for COVID-19.
Meindert Boysen, NICE Deputy Chief Executive and Director of the Centre for Health Technology Evaluation at NICE, said: “The joint NICE and NIHR guide on clinical evidence generation represents a key resource that will enable developers of potential medicines for COVID-19 to generate the highest quality evidence, within the constraints of the pandemic, to inform decision-making.
“The guide is also an important part in the overall collective approach to getting promising medicines for treating COVID-19 from research to patients as quickly and as safely as possible.”
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.”