Collect Digital Data

Opportunity

Participants expect a simple and convenient experience participating on clinical trials. To accomplish this goal, sponsors should consider the type, design and delivery of device (e.g., personal device,  provided by study, etc.) for participants to achieve accessibility, flexibility, convenience and maintain privacy. 

Considerations to Help Action the Opportunity

• Understand if the clinical trial design supports the applications of digital patient solutions
• Understand the needs and preferences of the participants taking part in the trial
  • Does the population have access to devices and data plans, or would they need these to be provisioned?
  • What devices would participants already have that could be used for clinical trials (e.g., wearables / sensors, glucometers, weighing scales, phones / tablets, etc.​)?
  • Understand impact on health equity (i.e., geographic, socioeconomic barriers) when implementing digital solutions 
• Partner with sites to gain their input on the impact of multiple services, training, and technology implementation
• Understand how the device may impact data integrity, regulatory landscape, site implementation and overall costs  
• Define how technology is designed, communicated and delivered for / to participants
• Define backup options (e.g., when a participant is unable to connect to device)

Value and Potential Benefits

• Increases access and ease of participation for participants on clinical trials by potentially reducing the number of site visits
• Allows for more robust datasets with improved data compliance and quality by enabling direct entry and near real-time review of data