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lüll End-points and clinical trial design in pulmonary arterial hypertension: have we made progress?Peacock AJ; Naeije R; Galie N; Rubin LEur Respir J 2009[Jul]; 34 (1): 231-42There is enormous interest in the treatment of pulmonary arterial hypertension (PAH), so it is appropriate to consider the design of trials of new therapies and the end-points to be measured when trying to decide whether or not a therapy is effective. In May 2003, the first meeting devoted solely to the discussion of end-points and trial design in PAH was held in Gleneagles, UK. At that time, most of the randomised controlled trials in PAH had used 6-min walking distance and/or resting haemodynamics as their primary end-points. The present article considers the progress that has been made since 2003. It deals with aspects of clinical trial design (such as noninferiority, superiority and withdrawal trials), considers end-points used in previous and current studies (such as 6-min walking distance, time to clinical worsening, haemodynamics, imaging and plasma brain natriuretic peptide), and considers what end-points might be used in the future. The second end-points meeting was held in Turnberry, UK, in June 2007. It had a similar format to the first meeting. Much of what is presented here is a summary of the workshops from that meeting. An attempt has been made to both summarise the current state of end-points and trial design and suggest new ways in which they could be improved. The present article forms one of a series being published in the European Respiratory Journal on pulmonary hypertension.|*Endpoint Determination[MESH]|*Randomized Controlled Trials as Topic[MESH]|Clinical Trials as Topic[MESH]|Echocardiography/methods[MESH]|Exercise Test[MESH]|Humans[MESH]|Hypertension, Pulmonary/diagnosis/*physiopathology/*therapy[MESH]|Magnetic Resonance Imaging/methods[MESH]|Quality of Life[MESH]|Research Design[MESH]|Respiratory Function Tests[MESH]|Tomography, X-Ray Computed/methods[MESH]|Treatment Outcome[MESH] |