The FDA is trying to learn more about virtual clinical trials, the bring-your-own-device (BYOD) model of provisioning and other aspects of today's tech-enabled research environment. The regulator has set up a docket to gather feedback on how researchers are using technology and what barriers are stopping more widespread adoption.
Officials at the regulator are seeking input on four specific issues, which collectively cover what tech is being used in trials, how the FDA could encourage adoption of such tools, what barriers are seen as blocking uptake today and how new models of research will affect patients. The FDA is particularly keen to learn whether the need to comply with regulatory requirements is seen as an impediment to the application of tech in trials, as well as whether gaining clearance from institutional review boards is an issue. The regulator sees benefits in the appropriate use of technology in clinical trials.
"Creative uses of technology in conducting clinical investigations have emerged over the previous decade and include advances that have the potential to improve recruitment, participation, and retention of trial participants," the FDA wrote. "New technology and communication infrastructure allow for collection of data and communication wherever the trial participant is located, including at his or her health care provider's location, creating opportunities to overcome geographical and logistical barriers … as well as facilitating the integration of research with clinical care."
While acknowledging the potential benefits of tech-enabled trials, the FDA wants to know more about possible detrimental effects on patients. More than half of the "issues for comment" section of the FDA notice is devoted to questions related to participants' acceptance, privacy and protection, such as potential concerns about the inadvertent disclosure of patient data. The regulator is also weighing up what can be done to prevent issues relating to the recruitment and retention of people with low levels of computer literacy from negatively affecting patients, trials and the data they generate.
Overall the tone of the questions is positive, though, with FDA coming across as wanting to establish the best ways to realize the benefits of tech-enabled trials. The tone is consistent with the FDA's take on tech in the past. The FDA gave its blessing to Pfizer's ($PFE) virtual REMOTE trial in 2011, setting many of the technologies discussed in this week's note on the path to more widespread use in the process. And the regulator has also said BYOD is compliant with 21 CFR Part 11.
- read the notice