Our results suggest that given the high within-person variability of this novel biomarker, BNP is unlikely to be a useful endpoint in the context of a repeated-measures study of the acute health effects of ambient air pollution.
In the context of our survey, we discuss some of the statistical issues that arise when dealing with HSCT endpoints and the ramifications of the choice of endpoint definition, when the endpoint occurs in the context of competing risks.
Because these endpoints were mainly described in the context of chemotherapies that are not generally curative, they may not adequately capture outcomes of new therapeutic modalities with potential for long-term survival.
Stent thrombosis, however, remains a surrogate safety endpoint and needs to be interpreted in the context of objective safety endpoints such as death and myocardial infarction.
Considerations with the use of PFS and OS as primary or supportive endpoints need to be weighed in the context of the specific tumor being studied and the implication, not only for regulatory approval but reimbursement as well.
Both definitions of general "clinical trial endpoints" and of CoP seem important in the context of this discussion: In clinical trials, the clinical endpoint is described as: "a characteristic or variable that reflects how a patient feels or functions, or how long a patient survives", which serves as the target outcome of the study.
The ProCess trial utilised aggressive resuscitation strategies, without an endpoint that reflected microcirculatory perfusion in the context of ongoing metabolic need.
The majority of RCTs addressed some CONSORT-PRO items: 27 (75%) RCTs reported results of pre-specified PRO endpoints or all domains of the PRO questionnaire used, 25 (69%) interpreted PROs in the context of clinical endpoints, 19 (53%) provided the number of participants included in each PRO analysis, and 23 (64%) cited evidence of the validity of the PRO questionnaire used.
We have described our results primarily in the context of endpoint stiffness.
Here we discuss methodological solutions to enhance the development decision at the end of phase II in the context of progression endpoints employed in randomized trials.
