Speakers
John Hubbard, PhD
Healthcare Strategic Advisory Board
Genstar Capital
Barry Peterson, PhD
Independent Consultant
Cheryl Grandinetti, PharmD
Office of Compliance, Office of Scientific Investigations, Division of Clinical Compliance Evaluation
Center for Drug Evaluation and Research
Food and Drug Administration
Topic
Advancing the Use of Mobile Technologies for Data Capture & Improved Clinical Trials
Keywords
Clinical trials; Mobile health technologies; Clinical Trials Transformation Initiative; CTTI; FDA; Data integrity
Key Points
- The goal of CTTI’s Mobile Clinical Trials program is to develop evidence-based recommendations that affect the widespread adoption and use of mobile technology in clinical trials for regulatory submission.
- Potential benefits of using mobile technology include higher quality, patient-centric endpoints and fewer barriers to participation in clinical trials.
- Data access issues to consider before selecting a mobile technology include:
- How will the data generated by the mobile technology be accessed and used by the manufacturer?
- What data will be provided by the manufacturer to the sponsor?
- The mobile era creates new data security demands.
Discussion Themes
CTTI’s recommendations aim to help sponsors determine the right device to use, how to write the protocol for remote data capture, and how to protect and analyze the data.
Know what you want to measure before selecting the mobile technology. The appropriateness of the selection should be justified through verification and validation processes.
Ensure the authenticity, integrity, and confidentiality of data over its entire lifecycle.
To reduce risk in large trials, conduct feasibility studies before full implementation.
Visit CTTI for more recommendations and resources for mobile clinical trials.
Tags
@CTTI_Trials, @PCTGrandRounds, #MobileTech, #pctGR