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 COVID-19 pandemic forced TransCelerate to actively evaluate our portfolio of ongoing & future initiatives and reprioritize activities to focus on solutions that have the potential to help immediately and in the longer term. At the end of last year, TransCelerate had the opportunity to analyze all 30 of our initiatives and apply the guiding theme of modernization across our portfolio planning. As part of the modernization effort, 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. The updated solutions are now available on the PT Solutions page.
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
For more information and to access our latest resources, please click Initiative Solutions.