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11.06.20

NIHR & NICE launch guide to Covid-19 clinical evidence generation

The current coronavirus outbreak has created an environment rife for technological development, and now to assist with the introduction of new technologies the NIHR and NICE have developed a guide on clinical evidence generation for the developers of medicinal products for Covid-19.

Aiming to promote the highest standards possible within the constraints of the pandemic in terms of registration, conduct and reporting of studies, it is hoped the new guidance will allow research on new treatments to be appropriately translated into clinical practice as soon as possible.

The guidance covers both confirmatory trials and real-world evidence collection on disease prevention and treatment, outlining the best practice approaches to a range of issues. These include trial design, population identification, the length of the trial and trial outcomes.

It is intended to 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.”

Read the newest publication here: Evidence collection guide for medicinal products to prevent or treat COVID-19

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