Digital Health Trials
CTTI Article Sheds Light on Participants’ Views of Mobile Clinical Trials
While adoption of mobile technologies presents many opportunities to enhance the quality and efficiency of clinical research, questions remain on patients’ preferences surrounding the use of mobile technologies in clinical trials. To help trial sponsors and others maximize the potential offered by mobile technologies, CTTI surveyed a group of potential research participants and recently published findings from the survey in Contemporary Clinical Trials Communications.
The survey results, which include responses from 193 individuals ages 23 to 83, shed light on the respondents’ perceptions of and willingness to participate in mobile clinical trials. In the survey, participants were presented with two similar hypothetical clinical trial scenarios: 1) relying on participants’ use of wearable and other mobile technologies outside of the clinic setting to collect study endpoints, and 2) relying on traditional in-clinic follow-up appointments with study staff to collect study endpoints. About 81 percent of respondents said they were willing to participate in the hypothetical mobile clinical trial, while only about 51 percent were willing to participate in the similar traditional clinical trial.
If given the option of participating in either scenario, the majority of respondents (76 percent) said they would prefer to participate in a mobile trial over a traditional one, citing greater convenience, fewer in-person visits, and perceived greater data collection accuracy offered by the mobile technology. Respondents were willing to use a variety of technologies―including mobile apps, wearable devices, and ingestible sensors―provided they were comfortable, convenient, and easy to use.
The survey also collected data about the aspects of mobile clinical trials that cause participants concern. Those who are less familiar with technology or do not use a smartphone said they are less likely to participate in a mobile clinical trial. Nearly half of respondents reported that they would not participate in a trial if there were no guarantees that their data would remain confidential, while others expressed concern about seeing a doctor less frequently in a mobile clinical trial setting.
CTTI’s findings contributed to the development of recently-announced recommendations and resources that help the research enterprise maximize the opportunities of mobile technologies to advance the development of new medical products. Related work and resources can be found as part of CTTI’s broader Mobile Clinical Trial program.
CTTI to Focus on Three Key Areas of Clinical Research Improvement and Innovation at DIA 2019
At this year’s DIA 2019 Global Annual Meeting, CTTI will share insights from three key areas of its work dedicated to enhancing the quality and efficiency of clinical trials. At the event, which will take place in San Diego from June 23-27, CTTI will present its recommendations and resources for enhancing patient engagement, investigator qualification, and the use of mobile technology in clinical research. Please join us at the following presentations:
Presentation: Measuring the Impact of Patient Engagement Activities in Medicines R&D: A Way to Sustain Cultural Change
Date & Time: Tues., June 25, 2:00 – 3:15 p.m. PT (GMT-07:00)
Presenter: Jaye Bea Smalley (Celgene Corporation)
Related CTTI Project: Patient Groups & Clinical Trials
Presentation: Identifying High-Value Patient Engagement Opportunities: A Collaborative Three-Step Process for Sponsors and Patient Groups
Date & Time: Wed., June 26, 8:00 – 9:15 a.m. PT (GMT-07:00)
Presenters: Linda Brennan (Cystic Fibrosis Foundation) and Jaye Bea Smalley (Celgene Corporation)
Related CTTI Project: Patient Groups & Clinical Trials
Presentation: Improving Trial Quality by Better Preparing Site Teams
Date & Time: Wed., June 26, 8:00 – 9:15 a.m. PT (GMT-07:00)
Presenters: Sabrina Comic-Savic (The Medicines Company), Christine Hildebrand (Amici Clinical Research), Jimmy Bechtel (SCRS), Janette Panhuis (Population Health Research Institute, McMaster University), Ronnie Todaro (Parkinson’s Foundation)
Related CTTI Project: Investigator Qualification
Presentation: Demystifying Technology Selection in Mobile Clinical Trials
Date & Time: Wed., June 26, 8:00 – 9:15 a.m. PT (GMT-07:00)
Presenters: Aaron Coleman (Fitabase), Barry Peterson (Wearable Devices, Independent Consultant), Isaac Rodriguez-Chavez (FDA/CDER), and Thomas Switzer (Genentech―a member of the Roche Group)
Related CTTI Project: MCT Mobile Technologies
Presentation: A New Path Forward for Using Decentralized Clinical Trials
Date & Time: Wed., June 26, 4:15 – 5:30 p.m. PT (GMT-07:00)
Presenters: Gail Adinamis (GlobalCare Clinical Trials), Michael O’Brien (The Avoca Group), Laura Podolsky (Science 37), and Penny Randall (IQVIA)
Related CTTI Project: MCT Decentralized Clinical Trials
CTTI Unveils New Database of Feasibility Studies on Mobile Technologies in Clinical Research
Mobile technologies present exciting opportunities for researchers to monitor participants outside of the clinical setting. However, with new solutions entering the market daily, it can be challenging to decide which technology option will be most effective for a particular trial.
To help stakeholders address this issue, CTTI has established a searchable online database of pilot studies that assess the feasibility of various mobile technology solutions. The Interactive Database of Feasibility Studies for Mobile Clinical Trials, part of CTTI’s Mobile Clinical Trials Program, is the first publicly available resource that contains a catalogue of published feasibility studies related to the use of mobile technologies in clinical research.
A CTTI manuscript recently published in npj Digital Medicine, describes how this tool will enable sponsors and researchers to capitalize on information gained from 275 previous pilot studies to reduce risk and optimize the effective use of wearables and other devices in clinical trials. The database will allow users to search by therapeutic area, technology type, participant characteristics, and other variables to explore a range of issues surrounding mobile technology, such as sensor performance and algorithm development.
“We are excited about the opportunities presented by this new resource,” said CTTI Executive Director Pamela Tenaerts. “CTTI is continually striving to provide relevant recommendations surrounding the rapidly changing field of mobile technology. The database aligns nicely with CTTI’s comprehensive set of resources that will help stakeholders adopt mobile technologies to make clinical trials more effective.”
Resources from CTTI extend beyond the database—it also has created a set of recommendations and a tool that can be used to select mobile technologies for data capture in clinical trials.
CTTI plans to regularly maintain and update the database to give online users easy access to the most current knowledge on the use of mobile technologies in clinical trials. Viewers can also help grow the resource by submitting a paper to the database.