Anzeige
Erschienen in:
24.06.2017 | Clinical Trials (J Butler, Section Editor)
Impact of Site Selection and Study Conduct on Outcomes in Global Clinical Trials
Erschienen in: Current Heart Failure Reports | Ausgabe 4/2017
Einloggen, um Zugang zu erhaltenAbstract
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.
Summary
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.