INCLUSION/EXCLUSION CRITERIA. 1. The following are considerations when defining the cardiac arrest trial patient population (i.e., the inclusion/exclusion criteria): The defined trial population can support a reasonable enrollment rate;
1. The following are considerations when defining the cardiac arrest trial patient population (i.e., the inclusion/exclusion criteria):
The defined trial population can support a reasonable enrollment rate;
The population defined has the potential for providing scientifically valid data;
b. Should the study only include those patients with documented ventricular fibrillation?
e. If field patients are to be included, should CPR be initiated by professionals only, or can patients be enrolled if timing is recorded by, and CPR is initiated by bystanders?
f. Do you have any other suggestions regarding the inclusion/exclusion criteria?
2. What would appropriate clinical endpoints be for efficacy in a cardiac arrest study?
3. Based on the clinical endpoints discussed above, what length of follow-up should be considered for the efficacy endpoints? E.g., If a device was associated with a 24 hour survival advantage but did not improve hospital mortality, would this device be considered efficacious?
4. What should the primary composite safety endpoint include?
5. What length of follow-up should be considered for the safety endpoint?
6. Can a scientific study be performed using a single arm study with historical controls (US and/or OUS)? If so, should the historical controls meet the same inclusion/exclusion criteria? Do you have any suggestions on how to reduce bias if historical controls and/or OUS data are used?
7. If the study is unblinded, do you expect any substantial positive or negative placebo effect, or an effect of investigator bias on patient selection or endpoint evaluation? If so, how can these problems be minimized?
8. Should the trial design be a non-inferiority (i.e., equivalence) or superiority study for safety and efficacy?
c. If superiority (i.e., new technology would need to demonstrate improvement over current technology), are there new clinical trial designs that can be considered, e.g., superiority for surrogate endpoint and equivalent hospital discharge rates; or additional post-market studies on devices/technologies to supplement initial pre-market approval safety/effectiveness data.
9. Discuss the possibility of developing a registry and using the data for future studies. What are some of the necessary data points that should be collected, keeping in mind the use of this data as historical controls for future studies.
10 Can uniform definitions of adverse events be created?
If yes, by whom?