Impact of Site Selection and Study Conduct on Outcomes in Global Clinical Trials.
Curr Heart Fail Rep
; 14(4): 203-209, 2017 08.
Article
en En
| MEDLINE
| ID: mdl-28647916
ABSTRACT
PURPOSE OF REVIEW There are over 25 million patients living with heart failure globally. Overall, and especially post-discharge, clinical outcomes have remained poor in heart failure despite multiple trials, with both successes and failures over the last two decades. Matching therapies to the right patient population, identifying high-quality sites, and ensuring optimal trial design and execution represent important considerations in the development of novel therapeutics in this space. RECENT FINDINGS:
While clinical trials have undergone rapid globalization, this has come with regional variation in comorbidities, clinical parameters, and even clinical outcomes and treatment effects across international sites. These issues have now highlighted knowledge gaps about the conduct of trials, selection of study sites, and an unmet need to develop and identify "ideal" sites. There is a need for all stakeholders, including academia, investigators, healthcare organizations, patient advocacy groups, industry sponsors, research organizations, and regulatory authorities, to work as a multidisciplinary group to address these problems and develop practical solutions to improve trial conduct, efficiency, and execution. We review these trial-level issues using examples from contemporary studies to inform and optimize the design of future global clinical trials in heart failure.Palabras clave
Texto completo:
1
Ejes tematicos:
Pesquisa_clinica
Banco de datos:
MEDLINE
Asunto principal:
Proyectos de Investigación
/
Salud Global
/
Ensayos Clínicos como Asunto
/
Estudios Multicéntricos como Asunto
/
Instituciones de Salud
/
Insuficiencia Cardíaca
Tipo de estudio:
Clinical_trials
/
Prognostic_studies
Límite:
Humans
Idioma:
En
Año:
2017
Tipo del documento:
Article