While the SARS-CoV-2 (COVID-19) pandemic has been terrible in terms of morbidity and mortality, it did show the promise of a clinical trial industry willing to change to meet a crisis. What if we use this precedent to improve clinical research before the next emergency? Any such changes would be disruptive to the industry but could overcome many of the system’s current flaws.

Frenova’s Vice President of International Clinical Research Services, Hans-Juergen Arens, Ph.D., describes seven major challenges inherent to the current model of clinical research. Dr. Arens then describes a disruptive change that would address each barrier while improving the industry experience for stakeholders, varying from regulatory change to improving risk-based monitoring systems to changing how clinical research protocols are executed. He brings a unique perspective and years of expertise to his solutions, as he has hands-on experience running international clinical trials. Read Dr. Arens’ approach to increasing the quality of modern clinical research published in International Clinical Trials.

This article is taken from International Clinical Trials November 2021, pages 28-30. © Samedan Ltd