By Clinical Informatics News Staff

October 29, 2015 | The Food and Drug Administration made a public solicitation today for stakeholder feedback, “on the scope and direction of the use of technologies and innovative methods in the conduct of clinical investigations.” The notice was posted in the Federal Register this morning with a 60-day open comment period.

“Specifically, FDA seeks information to understand individual and industry experiences with the use of such technologies to more efficiently conduct clinical research,” the notice read. “FDA also seeks stakeholder perspectives on possible barriers to implementing these technologies and methods to conduct clinical investigations.”

FDA acknowledged that clinical trials are essential to the Agency’s mission and noted that patient recruitment plays a significant role in the cost and complexity associated with trials. Creative technologies that improve trial recruitment, retention, and participation could help address costs, the Agency said, and improve trial reach by offering data collection and communication from the patient’s home. Innovative technologies, “may enhance the sponsor's ability to understand the safety and effectiveness of drugs, biologics, and medical devices; increase additional meaningful data gathering; minimize missing data; and maximize trial participation and retention,” the Agency said.

Specifically, FDA requested feedback on several key questions including which technologies are now being used to conduct trials; how FDA could encourage adoption of trial technologies; what clinical, cultural, business, regulatory, or other barriers are hindering technology; and how participants view these technologies.

Questions for patients represent the bulk of the proposed areas of comment. FDA wants feedback on how technologies impact participants’ interest in trials and their willingness to participate, and how that impact might change between different patient groups by demographic or disease area or geographic area.

The Agency hopes to explore the risks, challenges, and rewards associated with continuous or intermittent remote monitoring and data collection in trials. They would also like to investigate how a Bring Your Own Device (BYOD) model impacts data collection and participant satisfaction within a trial, and how patients’ own devices might be validated for data collection. Are there unique considerations for ensuring integrity of the source data, for example, authenticity and reliability?

Finally, FDA raises questions of computer literacy or access to technology and how trials can recruit and retain individuals who may have limited or no access to mobile technologies, computer devices, or the Internet.