Adjudication of cardiovascular events in patients with chronic obstructive pulmonary disease: SUMMIT trial.
Robert A WiseJulie A AndersonPierre AmarencoNicholas J CowansCourtney CrimMartin A DenvirCamilo R GomezMatthew Pa JonesAndrea MorrisDennis NiewoehnerJulie C YatesPublished in: Clinical trials (London, England) (2020)
A Clinical Endpoint Committee is useful for adjudication of major adverse cardiovascular events in chronic obstructive pulmonary disease trials but requires considerable resources and effort by investigators. This process can be streamlined by reviewing only serious adverse events and filtering by selected Medical Dictionary for Regulatory Activities terms.