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Trials in Pediatric PH: Specific Concerns in Design and Endpoints

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Conference: 2014 International PHA Conference and Scientific Sessions

Release Date: 03.27.2017

Authors

Dunbar Ivy, M.D.
Professor of Pediatrics
Selby's Chair in Pediatric Cardiology 
Children's Hospital Colorado
University of Colorado Hospital 

Educational Objectives

To support the attainment of knowledge, competence, and performance, the learner should be able to achieve the following objectives:
  1. Understand the difficulties in clinical trial design of PAH therapies in children
  2. Evaluate the challenges and opportunities in performance of the sildenafil trial in children 
  3. Identify potential strategies in performance of future clinical trials in children 

Intended Audience

This educational activity is designed for;
  1. Non-physician 
  2. Nurses
  3. Other
  4. Physicians

Unapproved/Off-Label Use Disclosure

The faculty of this educational activity discloses the following to the participants: 
  1. When products or procedures being discussed are off-label, unlabeled, experimental, and/or investigational (not US Food and Drug Administration [FDA] approved) 
  2. Any limitations on the information presented, such as data that are preliminary or that represent ongoing research, interim analyses, and/or unsupported opinion. Faculty may discuss information about pharmaceutical agents that is outside of FDA-approved labeling. This information is intended solely for educational purposes and is not intended to promote off-label use of these medications. If you have questions, contact the medical affairs department of the manufacturer for the most recent prescribing information.

Faculty, Planners, Staff Disclosure Information

All relevant financial relationships with any commercial interests and/or manufacturers must be disclosed to participants at the beginning of each activity. The faculty and planners of this educational activity disclose the following:
  1. Dunbar Ivy, M.D., is or serves as Consultant/Advisory Board/Steering Committee with Acetelion Pharmaceuticals, Gilead Sciences, Inc, Pfizer, United Therapeutics, and Bayer Healthcare.
  2. PHA and PESG Staff have no relevant financial relationships to disclose.