Lessons learned from a clinical trial: Design, rationale, and insights from The Cardiovascular Improvements with Minute Ventilation-targeted Adaptive Sero-Ventilation (ASV) Therapy in Heart Failure (CAT-HF) Study

2016 ◽  
Vol 47 ◽  
pp. 158-164 ◽  
Author(s):  
Mona Fiuzat ◽  
Olaf Oldenberg ◽  
David J. Whellan ◽  
Holger Woehrle ◽  
Naresh M. Punjabi ◽  
...  
Keyword(s):  
Heart Failure ◽  
Clinical Trial ◽  
Trial Design ◽  
Minute Ventilation ◽  
Clinical Trial Design ◽  
Lessons Learned ◽  
Design Rationale

scholarly journals Neurooncology clinical trial design for targeted therapies: Lessons learned from the North American Brain Tumor Consortium

2008 ◽  
Vol 10 (4) ◽  
pp. 631-642 ◽  
Author(s):  
Susan M. Chang ◽  
Kathleen R. Lamborn ◽  
John G. Kuhn ◽  
W.K. Alfred Yung ◽  
Mark R. Gilbert ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Brain Tumor ◽  
Targeted Therapies ◽  
North American ◽  
Trial Design ◽  
Clinical Trial Design ◽  
Lessons Learned ◽  
The North

scholarly journals Clinical Trial Design, Endpoints and Regulatory Considerations in Heart Failure

2019 ◽  
Vol 17 ◽  
Author(s):  
Giuseppe Rosano
Keyword(s):  
Heart Failure ◽  
Clinical Trial ◽  
Functional Capacity ◽  
Trial Design ◽  
Clinical Trial Design ◽  
New Drugs ◽  
Regulatory Agencies ◽  
Mortality And Morbidity ◽  
Increased Risk ◽  
New Treatments

After the withdrawal of flosequinan in the early 1990’s, because of an increased risk of mortality and fatal arrhythmias, the bar for the approval of new drugs in heart failure has been raised and regulatory agencies have requested evidence for the efficacy of new treatments on mortality and morbidity end-points. However, more recently, regulatory agencies have become more open to include the assessment of functional capacity as an efficacy endpoint, at least in selected subgroups of patients. Therefore, a new therapy for the treatment of heart failure can be approved if it improves survival and/or reduces hospitalisations or if it safely improves functional capacity. This article reviews clinical trial design, trial endpoints and regulatory issues in Heart Failure trials.

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