Consent Concerns Slow Clinical Trial mHealth Adoption


Jennifer Lentz, Eli Lilly and Company, speaking at the ACRP 2016 Meeting & Expo

MHealth technology is moving too quickly for regulatory bodies to keep up, according to panelists at the ACRP 2016 Meeting & Expo in Atlanta today.

Adoption has been slow in part because consent issues remain fuzzy, said Phillip Coran, Senior Director Quality and Regulatory Affairs at Medidata Solutions.

“We’re still at a pretty early stage of usage in clinical trials,” Coran told attendees. Across the board, the clinical trial industry remains hesitant to fully embrace mHealth usage despite its many benefits in terms of subject acquisition and utility.

There are 194 interventional trials in progress relying in some way on mHealth tools, according to data retrieved from in February, Coran noted.

Consent is always a big issue, as demonstrated by the fact that FDA issued findings to 42% of investigators audited. Inadequate informed consent was a top finding — including use of an incorrect version of the consent form. The vast majority of these trials do not include mHealth components. However, there is no reason to expect different findings for trials that do use them down the line, experts generally agree.

From the sponsor perspective, Eli Lilly Global Informed Consent Form Process Owner Jennifer Lentz is looking for “continued development” in four key areas:

  • Validation/qualification for use in trials,
  • Legal/regulatory guidance on the use of mHealth solutions,
  • Scientific and technical challenges related to use of mHealth solutions, and
  • Feedback from sites and patients regarding the usability of mHealth solutions.

From a regulatory perspective, FDA is focusing on the functionality of an mHealth device when determining whether or not it has oversight authority, Coran pointed out. Broadly speaking, the agency will focus its regulatory flashlight on three categories:

  • Apps that transform a mobile platform by using a mobile platform’s built-in features, such as light, vibrations or camera, to perform a medical device function,
  • Apps that connect an existing device type for purposes of controlling its operation, function, or energy source to control the operation or function of an implantable or body worn medical device, or
  • Apps that are used in active patient monitoring or analyzing patient-specific medical device data from a connected device.

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