Formats
CTTI Unveils Recommendations for Using Mobile Technologies in Clinical Research
New Recommendations and Resources Provide Road Map for Using Mobile Technologies for Data Capture in Clinical Research
In a special event today at the U.S. Food and Drug Administration’s (FDA) White Oak Campus, CTTI unveiled new recommendations for the use of mobile technologies in clinical research. The evidence-based recommendations and resources address an unmet need by outlining best practices for the use of mobile devices and applications to capture objective data—an approach that has the potential to increase the quality and efficiency of clinical trials.
“The clinical research community has long discussed an exciting future of using mobile technologies to collect objective, reliable data in clinical trials,” said CTTI Executive Director Pamela Tenaerts. “Today, we are excited to start making this vision a reality—sharing recommendations for capturing more informative real-world data from patients, reducing barriers to trial participation, and lowering costs associated with conducting clinical trials.”
The full set of recommendations and resources includes case examples and decision tools that offer practical guidance for:
- Selecting mobile technologies for data capture that are appropriate to the trial.
- Capturing complete, attributable, and high-quality data.
- Managing the data generated by mobile technologies—including safety considerations, data integrity, and security issues.
- Designing and executing a protocol that uses mobile technologies for data capture.
- Preparing for FDA submission and inspection.
This is the second set of recommendations from CTTI’s Mobile Clinical Trials Program for FDA-regulated trials. In 2017, CTTI announced recommendations for developing novel endpoints generated by mobile technologies. Later this year, recommendations will be released addressing patients’ and investigators’ needs regarding the use of mobile technologies in clinical trials and overcoming challenges to conducting decentralized trials in the U.S.
Sixteen Representatives Selected for the Patient Engagement Collaborative at FDA
CTTI and the FDA recently announced newly selected representatives for the Patient Engagement Collaborative (PEC), a joint endeavor announced in December 2017 to gather members of the patient community to discuss new ways for patients and the FDA to work together. These 16 representatives will meet with the FDA several times a year to discuss topics such as communication, transparency, and how patients can participate in the FDA’s regulatory discussions about medical products.
The representatives are:
- Dawn Aldrich
- Ronald Bartek
- Karen Erickson
- Jeffrey Goldstein
- Anne Hall
- Melissa Hogan
- Elizabeth Joniak-Grant
- Nancy Lenfestey
- Isabelle Lousada
- Stephanie Monroe
- Lawrence “Rick” Phillips
- Philip Posner
- Lynne Quittell
- Adrienne Shapiro
- Theresa Strong
- Dave White
The representatives were selected from nearly 200 nominations received in response to a Federal Register notice published in December 2017. The selection committee, which included patient advocates and staff from CTTI and the FDA, worked to identify representatives with diverse perspectives and experiences who could meaningfully contribute and express the patient voice.
“We are excited to welcome these experts to the PEC and are confident that they will make a significant contribution to advancing patient engagement in research and development,” said Pamela Tenaerts, MD, MBA, CTTI Executive Director. “This group will play a critical role in ensuring that every step of medical product development accounts for patients’ needs.”
The PEC was created as a response to public feedback the FDA requested on Section 1137, Patient Participation in Medical Product Discussions, of the Food and Drug Administration Safety and Innovation Act (FDASIA). One suggestion was to create an outside group to give input on patient engagement across the FDA.
Watch Live from FDA’s White Oak Campus: CTTI Unveils Mobile Technologies Recommendations
Are you interested in transforming clinical trials by using mobile technologies for data capture? A clear road map for making this vision a reality is now here.
Watch live as leaders in clinical trials and mobile technologies unveil CTTI’s new Mobile Technologies recommendations from the U.S. Food and Drug Administration’s (FDA) White Oak Campus. Throughout the day, attendees will hear insights and practical guidance for:
- Selecting mobile technologies for data capture that are appropriate to the trial.
- Capturing complete, attributable, and high-quality data.
- Managing the data generated by mobile technologies—including safety considerations, data integrity, and security issues.
- Designing and executing a protocol that uses mobile technologies for data capture.
- Preparing for FDA submission and inspection.
The event will culminate with an engaging panel discussion on the future of mobile technologies in clinical trials. Panelists will include Francesca Cerreta of the European Medicines Agency; Ray Dorsey of the University of Rochester Medical Center; Pat Furlong of Parent Project Muscular Dystrophy; John Hubbard of Genstar Capital; and Leonard Sacks of the FDA.
- Date and Time: Mon., July 16, 2018; 9:30 a.m. – 5:00 p.m.
- View agenda
- When it’s time, Join the Live Stream
CTTI Shares Latest Findings on Mobile Technology, Patient Engagement, and More at DIA 2018
At this year’s DIA 2018 Global Annual Meeting, CTTI will share insights across a broad range of topics that are core to its mission of enhancing the quality and efficiency of clinical trials. During the event, which will take place in Boston from June 24-28, CTTI will take part in 10 different presentations and sessions in areas ranging from patient-focused medical development to the use of mobile technology for data capture to quality approaches to clinical trial design.
Please join us at the CTTI exhibitor booth (#1624) and attend our presentations:
Presentation: The Metamorphasis of Clinical Trials: Evolving Roles of Stakeholders in Digital Trials
Date & Time: Mon., June 25, 11:00 a.m. – 12:00 p.m.
Presenters: Angela Botto-van Bemden (Arthritis Foundation)
Related CTTI Project: MCT Stakeholder Perceptions
Presentation: Patient-Focused Medicines Development: Where It Has Led Us Today, What Challenges Remain and What Do We Still Need to Do to Achieve Success?
Date & Time: Mon., June 25, 11:00 a.m. – 12:15 p.m.
Presenter: Pamela Tenaerts (CTTI)
Related CTTI Projects: Patient Groups & Clinical Trials
Presentation: The Who, What, How, When, and Why of Using Mobile Technology in Clinical Trials
Date & Time: Mon., June 25, 11:00 a.m. – 12:15 p.m.
Chair: Robert DiCicco (TransCelerate Biopharma)
Presenters: Philip Coran (Medidata Solutions), Cindy Geoghegan (Individual Patient/Caregiver), and Jan Hewett (FDA/CDER)
Related CTTI Project: MCT Mobile Technologies
Engage & Exchange Session: New Approaches, Novel Endpoints, and Next-Generation Trials
Date & Time: Mon., June 25, 1:45 – 2:45 p.m.
Chair: Jennifer Goldsack (CTTI)
Facilitators: Jessie Bakker (Philips Respironics), Daniel Karlin (Pfizer), and Komathi Stem (monARC Bionetworks)
Related CTTI Project: MCT Novel Endpoints
Presentation: A Quality-by-Design Approach to Trial Design and Conduct: Case Studies from the Clinical Trials Transformation Initiative
Date & Time: Mon., June 25, 3:00 – 4:15 p.m.
Chair: Annemarie Forrest (CTTI)
Presenters: Sabrina Comic-Savic (The Medicines Company) and Julie Dietrich (Amgen)
Related CTTI Project: Quality by Design
Content Hub: Developing Standards to Support the Use of Wearables and Sensors for Objective Data Collection During Clinical Trials
Date & Time: Tues., June 26, 1:30 – 2:00 p.m.
Presenter: Jennifer Goldsack (CTTI)
Related CTTI Project: MCT Mobile Technologies
Presentation: Debunking Decentralized Trials: Sharing Breakthroughs and Deal Breakers
Date & Time: Tues., June 26, 4:15 – 5:30 p.m.
Chair: Jane Myles (Genentech – a member of the Roche group)
Presenters: Gerrit Hamre (CTTI), Leonard Sacks (FDA/CDER), and Komathi Stem (monARC Bionetworks)
Related CTTI Project: MCT Mobile Technologies, MCT Novel Endpoints
Presentation: Building up Efficiencies, Breaking Down Barriers: Using Mobile Technology for Data Capture in Clinical Trials
Date & Time: Tues., June 26, 4:15 – 5:30 p.m.
Presenters: Sunil Agarwal (HCL America) and James Streeter (Oracle)
Related CTTI Project: MCT Data Collection
Presentation: Redefining the Site Investigator’s Experience
Date & Time: Tues., June 26, 4:15 – 5:30 p.m.
Presenters: Kaitlin Malone (Amgen)
Related CTTI Project: Investigator Community
Presentation: Data and Quality Approaches to Informing Global Investigative Site Selection
Date & Time: Wed., June 27, 8:00 – 9:15 a.m.
Chair: Stella Stergiopoulos (Tufts Center for the Study of Drug Development)
Presenter: James Kremidas (ACRP)
Related CTTI Project: Investigator Qualification
Poster: Effective Engagement Between Sponsors & Patient Groups: A Structured Process and Use Cases from CTTI
Date & Time: Wed., June 27, 9:30 – 10:30 a.m., 12:00 – 2:00 p.m., 3:00 – 4:00 p.m.
Presenter: Zach Hallinan (CTTI)
Related CTTI Project: Patient Groups & Clinical Trials
CTTI Welcomes NIH Leader to Executive Committee and Extends Terms of Three Current Members
CTTI is pleased to announce the addition of a leader in the National Institutes of Health’s (NIH) research initiatives to its Executive Committee, as well as the renewal of the appointments of three current members.
New EC member Jodi Black is the deputy director of the NIH Office of Extramural Research, where she oversees and supports initiative development, grants management policy and processes, and the small business and extramural technology development programs.
“CTTI’s work relies on input, participation, and collaboration across a range of public and private stakeholders in clinical research and development,” said CTTI Executive Director Pamela Tenaerts. “Jodi’s passion for challenging the status quo, as well as her experience building strategic alliances between academia, healthcare, and industry, will be invaluable to furthering CTTI’s efforts and advancing our mission to improve the efficiency and quality of clinical trials.”
CTTI is also delighted to extend the terms of current members Hans-Georg Eichler of the European Medicines Agency (until Dec. 31, 2020), Dalvir Gill of TransCelerate BioPharma Inc. (until Dec. 31, 2019), and Louis Jacques of ADVI (until Dec. 31, 2018).
“We are grateful for the continued commitment of Hans-Georg, Dalvir, and Louis, and excited for the valuable expertise Jodi brings to our committee,” said CTTI Executive Committee Chair Mark McClellan. “I’m confident that their leadership and insight will significantly contribute to the overall direction and strategy of CTTI and its impact on clinical research.”
Join Us at the FDA’s White Oak Campus for CTTI’s Mobile Technologies Event
Thank you for your interest in CTTI’s Mobile Technologies Event. As of June 8, seating is full for this event. We hope you can join us for the live stream from FDA’s White Oak Campus on July 16.
The use of mobile technologies for data capture has the potential to transform clinical trials. What has been missing is a clear road map for making this vision a reality. This will change on July 16.
Leaders in clinical trials and mobile technologies will gather for a special event at the U.S. Food and Drug Administration’s (FDA) White Oak Campus, where CTTI will unveil its new Mobile Technologies recommendations. Representatives from the multi-stakeholder group of experts who developed the recommendations will offer insights and practical guidance throughout the day.
The event will culminate with an engaging panel discussion on the future of mobile technologies in clinical trials. Panelists will include Francesca Cerreta of the European Medicines Agency; Ray Dorsey of the University of Rochester Medical Center; Pat Furlong of Parent Project Muscular Dystrophy; John Hubbard of Genstar Capital; and Leonard Sacks of the FDA.
MORE INFORMATION
- Date and Time: Mon., July 16, 2018; 9:30 a.m. – 5:00 p.m. (Add to Calendar)
- Location: FDA, White Oak Campus, Silver Spring, Md.
Objectives:
- Selecting mobile technologies for data capture that are appropriate to the trial.
- Capturing complete, attributable, and high-quality data.
- Managing the data generated by mobile technologies—including safety considerations, data integrity, and security issues.
- Designing and executing a protocol that uses mobile technologies for data capture.
- Preparing for FDA submission and inspection.
Visit the project webpage to view the full set of Mobile Technologies recommendations and resources.