In recent years, along side the increase in patient involvement in the design and conduct of research programs, there has been a notable increase in the idea of “virtual” or “decentralized” clinical trials. In the virtual trial model, clinical studies are focused on bringing the clinical study directly to the participant and allowing data collection to be completed in a participant’s home or local community. This paper examines the nature of virtual clinical trials, potential benefits and risks of this new paradigm, and best practices for maintaining regulatory and Institutional Review Board (IRB) compliance.
Other content in this Stream
In 2018 WIRB approved 100% of the single-patient EA requests that were submitted for review.
The impact of participant payments on clinical trial recruitment.
For biopharma sponsors, investigators, patients and families, these limitations are already translating into real impacts on development programs.
Studies show clinical trial participants want to know what was learned from their involvement. Many sponsors are implementing plans to deliver plain language summaries to trial participants.
Small and emerging biopharmas are conducting almost 50% of clinical trials in the U.S., often with lean teams, resources and infrastructure. Learn how to reduce the pressure on teams and timelines.
In June of 1966, physician-researcher Henry K. Beecher published a paper entitled “Ethics and Clinical Research.” Explore the history and motivation that led to Dr. Beecher’s ground-breaking paper.
Learn status of the requirements and recommendations for data-sharing from EMEA, FDA and PhRMA, and how to determine the steps to navigate the complicated field of data transparency compliance.
Learn about the regulatory framework that governs the use of investigational drugs outside clinical trials (formerly called “compassionate use”), and the ethical challenges surrounding it.