AHA Journals (American Heart Association)
Otavio Berwanger and M. Julia Machline-Carrion
30 Jun 2022, medicaldevice
Site version edited by:
Joaquim Cardoso MSc.
Health Revolution Institute
Digital Health Unit
June 30, 2022
What is the problem?
- As stroke continues to represent a major global health care problem, advancing our knowledge of new effective and safe stroke interventions represents a public health priority.
- The identification of these therapies requires the conduct of high-quality and well-powered randomized clinical trials.
- Despite its potential to inform clinical practice, traditional randomized clinical trial models have their drawbacks, including elevated costs, long completion times, failure to recruit the target sample sizes, lack of diversity, and complex operational procedures.
- Therefore, improving the participants’ experience and trials’ overall efficiency constitutes an important unmet need.
What is the solution?
- Innovative models such as virtual and decentralized patient-centric trials have been proposed as a valuable strategy in this pursuit.
What is the scope of the study?
- In this narrative review, we discuss the limitations of traditional randomized clinical trial models
- and present the concept, advantages, and challenges of decentralized digitally enabled approaches to the conduct of stroke clinical trials.
Originally published at https://www.ahajournals.org
About the authors
Otavio Berwanger, MD, PhD,
Academic Research Organization,
Hospital Israelita Albert Einstein
São Paulo SP
M. Julia Machline-Carrion,
Department of Medical Affairs,
epHealth Primary Care Solutions,
Florianópolis, Santa Catarina, Brazil (M.J.M.-C.).