Virtual Clinical Trials Challenges and Opportunities: Proceedings of a Workshop (2019) / Chapter Skim
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6 Reflections on the Workshop and Potential Future Directions
6 Reflections on the Workshop and Potential Future Directions
Pages 65-70
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From page 65... ...
Given this dysfunction, he highlighted the need for the next generation of clinical t rials, which, of course, should incorporate new technologies. Johnston then emphasized comments by workshop participants, such as the importance of using human-centered design and seeking input from patients early in the trial design process.
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From page 66... ...
Interventional clinical trials have made good use of virtual or direct-to-participant methodologies when digital tools are incorporated into the trial design from the beginning rather than when a traditional clinical trial, with all of its complexity, is later modified to incorporate digital tools. Another point she made regarding interventional trials was the importance of considering what participant access to data looks like in the virtual environment.
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NEXT STEPS Johnston discussed the value of establishing a regularly updated knowledge repository for sharing information and lessons learned based on ongoing and completed virtual trials (e.g., Health Insurance Portability and Accountability Act [HIPAA] considerations and state-based policies)
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Addressing Regulatory Policy Johnston suggested that the workshop participants have the potential to work with various organizations to advocate for policies that would etter support virtual trials. Hudson added that a number of regulatory b policy issues stand in the way of modern and traditional clinical trials.
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From page 69... ...
to treat patients at any VA facility in the country, regardless of state licensure provisions." Craft then suggested one small step that Congress could take, which would be to carve out an exemption to state laws for telemedicine-based clinical research or telemedicine-based clinical research for rare diseases, each of which represents a tiny slice of medical practice. McCallie commented that an economic analysis comparing traditional trials versus virtual trials could help identify challenge areas and potential advocates.
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