Regulators

UK: NHS Health Research Authority

“The COMET Initiative supports investigators in developing and applying agreed standardised sets of outcomes, known as a ‘core outcome set’. These sets represent the minimum that should be measured and reported in all clinical trials, audits of practice or other forms of research for a specific condition. They do not imply that outcomes in a particular study should be restricted to those in the core outcome set. Rather, there is an expectation that the core outcomes will be collected and reported to allow the results of trials and other studies to be compared, contrasted and combined as appropriate; and that researchers will continue to collect and explore other outcomes as well.”

Europe: European Medicines Agency

The Guideline on the clinical investigation of medicinal products for the treatment of asthma states that: The use of core outcome sets (COS) is recommended to allow comparisons of the results across clinical trials when investigating controller medications. COS should include asthma control (symptom scores, exacerbations and change in lung function)