Importance of swift event adjudication of endpoints for adequate reporting to data and safety monitoring boards in clinical trials-lessons from CULPRIT-SHOCK

• Published in: Current controlled trials in cardiovascular medicine Vol. 22; no. 1; p. 197
• Main Authors: Clemmensen, Peter, Schrage, Benedikt, Zeymer, Uwe, Thiele, Holger, Wegscheider, Karl
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 08.03.2021; BioMed Central; BMC
• Subjects: Clinical trials; Consent; Forecasts and trends; Letter; Methods; Mortality; Outcome and process assessment (Health Care); Patient safety; Renal replacement therapy; Safety and security measures; Trends; Germany
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-021-05129-4

First of all, the principal investigator and associated advisors form the Steering Committee, which is responsible for executive tasks such as trial design and oversight. [...]a Data Safety Monitoring Board (DSMB) is needed to review the event and outcome data. The trial was to be stopped “if the null hypothesis of equal event rates can be rejected with a significance level of 0.005”. [...]the attained p value for the primary endpoint at the time when half the patients had been enrolled was close to the stopping rule with a 0.004 margin. See PDF.] Comparison of adjudicated and un-adjudicated mortality events during the life cycle of the CULPRIT-SHOCK study, as reported to the DSMB These different trends made it difficult to assess whether there were inacceptable risks for the study population which prompted the DSMB to address the steering committee and recommend a continuation of the study under the condition that an immediate plan be set forward for the CEAC to promptly adjudicate the reported events.