Keeping up with mHealth in Clinical Trials

Keeping Up with mHealth in Clinical Trials

The use of mobile health (“mHealth”) technologies in clinical trials is exploding. These new technologies can be used to support clinical trials in a variety of ways, from recruitment to retention. More importantly, data is beginning to be available that mHealth technologies can help provide tangible cost savings. The FDA maintains that it supports the use of new technologies – but can regulators and IRBs keep up with these rapid changes?

New technologies, including mobile devices and mobile device applications, can be used in clinical trials in a wide variety of ways. Possible uses of mHealth technologies include:

  • Mobile apps that provide patients with access to studies they would not otherwise know about;
  • Online site and patient education/administration training;
  • Wireless data tracking via devices, such as ECGs administered by home health nurses;
  • Online patient surveys and assessments;
  • Personalized patient retention activities such as visit, medication and diary reminders via email or text messages; and
  • The “gamification” of study activities to improve participant retention.

CenterWatch Weekly recently reported on the use of wireless data tracking in a clinical trial. According to the report, a wearable device is being used in a Phase III clinical trial of patients with Parkinson’s Disease[1]. The device used in the trial is similar to a smartwatch and is equipped with motion sensors to detect when patients have an “OFF” episode—a period where medicine stops working and motor impairment symptoms return. The symptoms include muscle stiffness or problems with starting movements, such as starting to walk or getting out of a chair. The device will be used to assess the effectiveness of a trial drug that is specifically designed to treat “OFF” episodes in patients with Parkinson’s.

Experts project that the adoption of mHealth technologies can help reduce the costs of conducting clinical trials dramatically. A report by the U.S. Department of Health and Human Services projects that the use of mobile devices in clinical trials could save millions of dollars in all phases of clinical research.[2] The report also projects that wider use of at-home testing could save millions of dollars in recruitment and retention efforts, because “if it is more convenient for patients to fulfill trial requirements, they may be more willing to participate in studies.”

Evidence from a recent study confirms the advantages of using mHealth technologies. In a recent clinical trial, a research team at the University of Washington compared three types of mood apps to treat depression in adults. The team used BRIGHTEN (Bridging Research Innovations for Global Health through Technology, Emotion and Neuroscience), a mobile research platform that enables data to be collected on mood, cognition, and physical and social activity via smart phone apps and social media. The lead investigator, Dr. Patricia Areán of the University of Washington, hoped to enroll 150 participants in the study and was pleasantly surprised to enroll 150 in the first week alone. The team obtained permission from the funding agency, the NIH, and the IRB to continue enrolling – and eventually enrolled 2,900 participants.[3]

The BRIGHTEN research team was also pleased with retention rates. The study did experience attrition: during the 12-week trial, 66% of participants lasted four weeks, 50% made it to eight weeks and 41% completed the full 12-week study. The BRIGHTEN research team noted that the retention rates were still higher than the average internet-based, randomized, controlled trial. The team also pointed out that the trial was completely automated; research indicates that retention possibly could be improved by providing more direct contact with participants, possibly through videoconferencing or other technologies.

The FDA clearly supports expanding the use of digital technologies, even though the agency’s regulations seem to be lagging behind. The agency recently published a final guidance on the regulation of mobile medical applications,[4] which confirms the agency’s intention to not enforce compliance with its applicable regulations for technologies that receive, transmit, store, or display data from medical devices. According to FDA officials, “[w]e hope that finalization of this policy will create an impetus for the development of new technologies to better use and display”[5] medical data.

Institutional review boards and other ethics committees should consider a number of issues when reviewing the proposed use of a mobile device in a clinical trial. A number of issues raised in the FDA’s draft guidance on eConsent technologies[6] are also pertinent to mobile devices. According to this draft guidance, an IRB should consider

  • The ability of individuals to access or use the technology, especially individuals with poor eye sight or impaired motor skills;
  • The ability of the study team to verify the identity of the individual using the technology;
  • The availability of the study team to answer questions of study participants; and
  • Security measures to ensure the privacy and confidentiality of information collected with the electronic technology.

When considering the use of a mobile device in a clinical trial, an IRB also should consider the possibility that the device could collect collateral information unrelated to the clinical trial, as a smartphone can provide access to personal information such as geographic location, personal contacts, and web searches. The IRB also should consider the implications of using a technology that might be inaccessible to populations without access to or familiarity with computers or smartphones.

The use of new mHealth technologies offers great promise for clinical trials. For in-depth discussion and analysis of the ethics and regulation of mHealth, join federal regulators, investigators and IRB members at the conference “Ethics and Regulation in the Digital Age” on July 21 in Seattle, Washington. Registration for in-person attendance or the live webinar is available at nwabr.events/irb-conference-2016.


 

[1] Lisa Chantos, “Wearables Track Drug Effectiveness in Parkinson’s Patients”, CenterWatch Weekly Vol. 20, Issue 2 (January 18, 2016).

[2] U.S. Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation,
“Examination of Clinical Trial Costs and Barriers for Drug Development” (July 25, 2014), available at https://aspe.hhs.gov/report/examination-clinical-trial-costs-and-barriers-drug-development

[3] Lisa Chantos, “Can Trials be Conducted 100% via Mobile App? Results Say Yes”, CenterWatch Weekly Vol. 20, Issue 8 (February 29, 2016).

[4] FDA, “Mobile Medical Applications: Guidance for Industry” (February 9, 2015), available at http://www.fda.gov/downloads/MedicalDevices/…/UCM263366.pdf

[5] Bakul Patel, Associate Director for Digital Health in FDA’s Center for Devices and Radiological Health, and Jeffrey Shuren, Director of FDA’s Center for Devices and Radiological Health, FDA Voice, “Smart Ways to Manage Health Need Smart Regulation” (February 6, 2015), available at http://blogs.fda.gov/fdavoice/index.php/2015/02/smart-ways-to-manage-health-need-smart-regulation/

[6] FDA Draft Guidance for Industry, “Use of Electronic Informed Consent in Clinical Investigations: Questions and Answers” (March, 2015), available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM436811.pdf

 

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