Theresa Olasveengen, Victoria Cornelius, and Christopher Seymour join trialists Mikael Fink Vallentin and Lars Andersen, as well as editorialist Gavin Perkins, to discuss the COCA trial. They explore the stone heart phenomenon, the use of dual analytic approaches in trials, and reflections on trial design and execution.
The COCA trial experienced unusual decisions from the Data Monitoring Committee, including increasing the sample size and terminating the trial due to a signal of harm.
Setting predefined statistical criteria for stopping a trial due to harm is challenging, and more research is needed to explore subgroups and potential mechanisms for harm in administering calcium during cardiac arrest.
Deep dives
Impressed by the trial team's bravery and execution
The speaker commends the trial team for their bravery in taking on a difficult trial and executing it well.
Mixed decisions from the Data Monitoring Committee
The trial experienced a series of unusual decisions from the Data Monitoring Committee (DMC), including increasing the sample size and ultimately terminating the trial due to a signal of harm.
Challenges in establishing stopping criteria for harm
The speaker highlights the difficulty in setting predefined statistical criteria for stopping a trial due to harm, particularly when compared to the criteria for stopping for benefit.
Implications for practice and need for further research
The results suggest that there is not enough evidence to support the practice of administering calcium in cardiac arrest. However, the speakers acknowledge the need for more research to explore subgroups and potential mechanisms for harm.
Theresa Olasveengen (Oslo, Norway), Victoria Cornelius (London, England) and Christopher Seymour (Pittsburgh, USA) join trialists Mikael Fink Vallentin and Lars Andersen (Aarhus, Denmark), as well as editorialist Gavin Perkins (Coventry, England), to discuss the COCA trial.
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