Editor's response to “Ethical issues associated with globalization of placebo-controlled trials in pulmonary arterial hypertension”

Park, Myung H.; Rubin, Lewis J.

doi:10.1016/j.healun.2010.03.009

Cited by 1 publication

(1 citation statement)

References 14 publications

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“…In addition, standard of care, facilities, and quality of care is quite diverse. Clinical trial sites must have sufficient manpower and training to ensure that patients' rights and safety are not compromised by trial enrollment (101,102). Many countries have limited funds for treating patients with orphan diseases and, thus, cannot approve all therapeutics.…”

Section: Ethical/global Issues In Drug Development For An Orphan Diseasementioning

confidence: 99%

New Trial Designs and Potential Therapies for Pulmonary Artery Hypertension

Gomberg‐Maitland

Bull

Saggar

et al. 2013

Journal of the American College of Cardiology

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115

110

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A greater understanding of the epidemiology, pathogenesis, and pathophysiology of pulmonary artery hypertension (PAH) has led to significant advances, but the disease remains fatal. Treatment options are neither universally available nor always effective, underscoring the need for development of novel therapies and therapeutic strategies. Clinical trials to date have provided evidence of efficacy, but were limited in evaluating the scope and duration of treatment effects. Numerous potential targets in varied stages of drug development exist, in addition to novel uses of familiar therapies. The pursuit of gene and cell-based therapy continues, and device use to help acute deterioration and chronic management is emerging. This rapid surge of drug development has led to multicenter pivotal clinical trials and has resulted in novel ethical and global clinical trial concerns. This paper will provide an overview of the opportunities and challenges that await the development of novel treatments for PAH.

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Section: Ethical/global Issues In Drug Development For An Orphan Diseasementioning

confidence: 99%