FDA is soliciting public input from a broad group of stakeholders regarding technologies and innovative methods for using technology to more efficiently conduct clinical research. FDA is interested in identifying new opportunities to study medical products, as well as receiving comments on barriers, challenges, and relevant considerations that may affect a medical product clinical investigation that uses these technologies and methods.
In addition to the general information requests in section II of this document, FDA is interested in obtaining information and public comment on the following specific issues:
1. What technologies, communication infrastructure, or innovative methods are being used to conduct clinical investigations?
2. What are ways FDA could encourage adoption of these technologies and innovative methods in the conduct of clinical investigations?
3. Identify any clinical, cultural, business, regulatory, or other barriers perceived by stakeholders that serve as a disincentive to the use of technology to facilitate the conduct of clinical investigations.
4. FDA is interested in obtaining information on potential trial participant acceptance, privacy, and human subject protection issues that may occur as a result of the use of technologies and innovative methods for the conduct of clinical investigations. In particular, FDA is interested in assessing potential trial participants’ interest, tolerance, concerns, and willingness to participate in clinical investigations that involve nontraditional settings or utilize new technologies. FDA is also interested in identifying the factors that affect trial participant awareness, acceptance, enrollment, and retention for these investigations.
Submit electronic or written comments by December 28, 2015