Analysis of terminated pulmonary hypertension clinical trials. What are we doing wrong?

Autor: Abdulelah M; Department of Internal Medicine, University of Massachusetts Chan Medical School - Baystate, Springfield, MA 01199, USA., Abdulelah ZA; Department of Cardiology, Royal Papworth Hospital, Cambridge, UK. Electronic address: Zaidaabdulelah@gmail.com., Azzam M; Evidence-Based Practice and Impact Center, Department of Internal Medicine, University of Kansas Medical Center, Kansas City, KS 66160, USA., Ghalayni R; Department of Internal Medicine, Northwestern Medicine, McHenry IL 60051, USA., Kawtharany H; Evidence-Based Practice and Impact Center, Department of Internal Medicine, University of Kansas Medical Center, Kansas City, KS 66160, USA., Khraisat F; Faculty of Medicine, University of Jordan, Amman, Jordan 11942, Jordan., Abdulelah H; Faculty of Medicine, University of Jordan, Amman, Jordan 11942, Jordan., AlQirem L; Internal Medicine Division, University of Arkansas for Medical Sciences, Little Rock, AR 72205, USA., Abdulelah AA; Edinburgh Medical School, The University of Edinburgh, UK.
Jazyk: angličtina
Zdroj: Current problems in cardiology [Curr Probl Cardiol] 2024 Oct; Vol. 49 (10), pp. 102775. Date of Electronic Publication: 2024 Jul 30.
DOI: 10.1016/j.cpcardiol.2024.102775
Abstrakt: Despite significant interest in the diagnosis and treatment of pulmonary hypertension (PH) over the past two decades, there have been no notable advancements in reducing mortality. One contributing factor to this lack of progress is the insufficient number of well-designed and conducted trials. We aimed to evaluate factors associated with termination of PH clinical trials, to serve as a reference when designing future trials. We searched the ClinicalTrials.gov database for PH clinical trials conducted between January 1st 2000 to December 31st 2020. Information collected and analyzed included trial design, status, and publication status. Of the 240 analyzed clinical trials, 81% evaluated therapeutic interventions. Around 30.4% of the trials were terminated, most commonly due to recruitment issues. Terminated trials had a significantly lower number of enrolled patients when compared to trials that were completed (p= .017). Furthermore, there was an overall negative correlation between the year of trial initiation and the total number of enrolled patients (r= -0.18; p= .013). The likelihood of termination decreased by 1.9% for every additional enrolled patient. Ultimately, only 37.5% of the trials have been published. There was a significant positive correlation between number of patients enrolled and the journal's impact factor (r = 0.4, p < 0.05). Pharmaceutical companies sponsored the majority of the trials. The termination rate of PH trials is higher than other conditions. Factors such as recruitment contribute significantly to termination. Further studies are required to evaluate the challenges associated with recruiting this patient population.
Competing Interests: Declaration of competing interest None of the authors have any conflicts of interests to declare.
(Copyright © 2024 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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