San Francisco Partner Kai Peters was quoted in a recent Daily Journal article covering the legal issues relating to virtual clinical drug trials in which pharmaceutical companies conduct patient trials using mobile devices and Internet technology instead of traditional in-person doctor visits to collect data from trial participants.
According to the article, the U.S. Food and Drug Administration recently approved a pilot clinical trial project as part of the agency's efforts to streamline the clinical trial process and help make experimental drugs available to more people, sooner. The pilot project involves researchers who will recruit patients online, qualify participants for the study, explain the risks involved and obtain their consent to participate in the clinical trial using video and other multimedia tools on the Internet. Patients in the pilot project will take the covered drug and document their experiences in real time with a cell phone application and in periodic online reports.
Excerpts from the article regarding Mr. Peters' analysis include the following:
"There's risks and benefits in whatever system you set up. I do see the potential for less liability when you have enhanced forms of communication. I think that clients will be interested for sure in cost effectiveness and streamlining the process, but also in terms of being able to do more for more patients."
Peters said issues surrounding online communication in clinical trials must be addressed, including Internet security to prevent the loss of data or disclosure of private patient information. "I think you could potentially see increased claims across the gamut of what pharmaceutical companies see, such as failure to disclose or miscommunication of the risks, when you don't have people meeting face-to-face with physicians." Companies that decide to use the Internet in clinical trials likely will be selective about which drugs and medical devices they test in online studies. For example, Peters said it wouldn't be appropriate to study a skin treatment without researchers examining the patient and documenting the degree of improvement caused by the drug. "I think companies will take a very close look at it," Peters said. "It will be tailormade for certain situations - those where an in-person visit is not as critical."