Should protocol proposals be limited to a specific heart failure population?
The network is intended to have the capacity to evaluate the spectrum of disease including advanced CHF. Responsive research proposals and estimates of numbers of cases may include hospitalized patients as well as out-patients. Q: In providing (at least) two protocols, do these protocols have to be using the same approach or can they be different? A: Proposed protocols can stand independently, addressing specific needs in separate areas of investigation. Q: Should protocols be simple or can they be more complex? A: The applicant should select protocols to reflect what they consider important .and that take advantage of the proposed infrastructure of the network. It is preferable that protocols submitted NOT be restrictive requiring only a single center. Large phase III trials would not be responsive. Whether complex or simple, proposed protocols should provide study rationale and hypothesis, and detail study design, endpoints and statistical considerations with total sample size estima
Related Questions
- Should the two (2) protocol proposals be limited to the resources available at one CC, or should they be proposed on a network scale?
- Should protocol proposals be limited to cardiac arrest/resuscitation, or is there room for work in the pre-arrest period as well?
- Should protocol proposals be limited to a specific heart failure population?
