Rationale
In alignment with the rise of use of personal digital technologies for health and wellness, clinical trials can be transformed through patient-facing technologies by:
- Improving the patient experience during clinical trials (e.g.: less site visits)
- Enabling broader patient participation in clinical trials (e.g.: remote participation)
- Enabling collection of richer, more meaningful data (e.g.: real-world, real-time)
- Improving outcome measures in clinical trials to positively impact the broader patient community (e.g.: improved safety profiles)
Despite these benefits, there is limited use of patient-facing technologies within clinical trials. Greater collaboration and knowledge sharing among regulators, sponsors, vendors, patients and other players in the clinical ecosystem could help address these barriers.
Since the original solution launch, the Patient Considerations Guide and Patient Technology Site Feedback Questionnaire (PTSFQ), within the Patient Technology Toolkit, were updated to include considerations around decentralized trials, patient inclusion and diversity, and other topics. Additionally, the Regulatory Landscape Tool was updated in 2023 to reflect new digital technology guidance and to highlight UK regulations.
Benefits
The Patient Technology Initiative was developed to enable and accelerate patient-facing technology in support of an improved patient experience and richer data collection in clinical trials. By fostering industry-wide collaboration regarding the use of patient-facing technologies, the initiative was designed to:
- Facilitate a patient-centric approach to technology enablement within clinical trials
- Understand current regulatory implications of the use of patient-facing technologies
- Improve efficiency and effectiveness of patient technology implementation through knowledge sharing and tool development
- Develop a framework for using digital means more efficiently for evidence generation
