Mobile technologies in Clinical Trials: Detailed Roadmap from CTTI and FDA
[Posted on: Thursday, August 16, 2018]

A report released last month by the Clinical Trial Transformation Initiative (CTTI), a joint venture of FDA and the Duke University, contends that all clinical trials should use mobile technologies to increase patient participation and retention, while reducing cost, increasing efficiency, and capturing real-time and real-world clinical data. The report acknowledges that the sponsors will need to do extra work to pick appropriate mobile technology for use in their clinical trials but indicates that FDA will be supportive of creative approaches to involve such devices in all clinical trials irrespective of the kind of product (drug, biologic or device) being evaluated. Mobile technologies include any device that contains sensors for remote capture of data such as apps on mobile phones and other wearables, ingestibles, implantables, and portable technologies residing on laptops, tablets and other non-wearable devices. Mobile technologies are widely available at low cost and reasonable internet connectivity. Mobile technologies are highly favored by patients as they reduce clinical visits, automate data transfer, and make it very convenient to participate. But they pose challenges in terms of FDA acceptance of the selected technology; collection and analysis of data; quality, reliability and integrity of data; and verification or audit of the collected data. The CTTI report provides stepwise instructions on all aspects of the adaptation of the mobile technologies in clinical trials provides practical common sense suggestions, and instructions on implementing the suggestions. Some notable recommendations are to consider all technologies available in the market and not worry about the FDA approval status of a given technology, feasibility testing before full-scale implementation, and sharing data collected through mobile devices with the study participants in real time. Being able to use “consumer” technologies in clinical trials could make is much easier for both the sponsors and the participants to find suitable technologies. Similarly, feasibility studies can help evaluate and troubleshoot technologies prior to full-scale application. Sharing data real time with the participants could pose challenges but could also increase patient engagement by sharing ownership of the data. FDA has previously published guidance of using new endpoints suitable for mobile devices.  FDA has also previously published its recommendations to use of electronic systems in clinical trials.  The new recommendations should be read in the context of the previous FDA advice regarding mobile technologies and systems in clinical trials. CTTI recommendations were prepared by a variety of stakeholders and should be followed by all sponsors considering mobile technologies in their clinical trials.