In March 2020, at the height of the COVID-19 outbreak, the FDA issued a new guidance providing advice to pharmaceutical companies about how to run virtual clinical trials, not just for potential virus remedies but for any drug they are developing. But even before the virus forced mass quarantining, the FDA was urging drug developers to embrace modernized R&D technologies and protocols—including virtual clinical trials—to speed up development and improve the diversity of patients enrolled in their studies.
In a virtual clinical trial, patients forgo many site visits and instead use telephone conversations, videoconferencing, mobile apps, e-mail and social media to provide investigators with real-time data and information about their symptoms. Studies have shown that the number of recruited patients increases significantly when travel requirements are removed, and the drop-out rate in phase 3 trials can be reduced by as much as 40%.
This Fierce webinar will bring together executives with expertise in R&D and technology implementation to explain the potential benefits of virtual clinical trials, as well as the ins and outs of designing and running them. It will include representatives from companies that have completed virtual clinical trials successfully and can provide advice on what did and did not work.
- How the latest sensors, diagnostics and wearable technologies can be used to record symptoms and collect data in clinical trials.
- FDA rules and other regulations that apply to virtual clinical trials and how they affect trial design and recruitment.
- Best practices for implementing technology tools to guarantee security and protection of patient privacy.