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Pulm Circ. 2013 Jan;3(1):217-25. doi: 10.4103/2045-8932.109933.

Advancing clinical trial design in pulmonary hypertension.

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1
Aptiv Solutions, Innovation Centre, Stevenage Bioscience Catalyst, Gunnels Wood Road, Stevenage, Hertfordshire, SG1 2FX, UK.

Abstract

In pulmonary hypertension, as in many other diseases, there is a need for a smarter approach to evaluating new treatments. The traditional randomized controlled trial has served medical science well, but constrains the development of treatments for rare diseases. A workshop was established to consider alternative clinical trial designs in pulmonary hypertension and here discusses their merits, limitations and challenges to implementation of novel approaches.

KEYWORDS:

Bayesian modeling; adaptive designs; clinical trial design; group sequential designs; modeling and simulation; population enrichment; pulmonary arterial hypertension

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