Education Posts

Group Clinical Trial Science

Article Type: Novel Designs

Building The Case for Novel Clinical Trials in Pulmonary Arterial Hypertension

This paper discusses the various possible clinical trial designs that are well suited for a disease like PAH. The authors point out that orphan diseases make the typical parallel design of randomized blinded trials difficult and often risky. Novel trial designs can result in smaller trials which are less costly, while at the same enriched to allow for larger treatment effects.

Citation
Ryan JJ, Rich JD, Maron BA. Building the case for novel clinical trials in pulmonary arterial hypertension. Circ Cardiovasc Qual Outcomes. 2015 Jan;8(1):114-23.
Source: https://pubmed.ncbi.nlm.nih.gov/25604559/

New Trial Designs and Potential Therapies for Pulmonary Artery Hypertension

This review focuses on the pitfalls of traditional randomized clinical trials, and suggest more modern approaches with new endpoints. Co-authored by members of the FDA, they also discuss newer treatments under development which may be better suited for these strategies.

Citation
Gomberg-Maitland M, Bull TM, Saggar R, Barst RJ, Elgazayerly A, Fleming TR, Grimminger F, Rainisio M, Stewart DJ, Stockbridge N, Ventura C, Ghofrani AH, Rubin LJ. New trial designs and potential therapies for pulmonary artery hypertension. J Am Coll Cardiol. 2013 Dec 24;62(25 Suppl):D82-91.
Source: https://pubmed.ncbi.nlm.nih.gov/24355645/
Back Education Center

© Copyright 2024 Tenax Therapeutics. All Rights Reserved.
Site created by Top Shelf Design