Coming Soon: Novel Digital Endpoints Consideration Paper
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. Currently, there is lack of collaboration and knowledge sharing among various players in the clinical ecosystem (e.g.: sponsors, regulators, vendors, patients). Further, due to a lack of regulatory guidance and a limited understanding of global regulatory perceptions, there is a general lack of regulatory certainty. Greater collaboration and knowledge sharing among regulators, sponsors, vendors, patients and other players in the clinical ecosystem could help address these barriers.
The Patient Technology Initiative strives 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 intends 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
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