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
The first asset to be released by the team will be the Patient Technology Point of View Paper, with expected delivery in 2018. This paper will provide a multi-stakeholder landscape assessment highlighting current benefits, gaps, and opportunities.
The Patient Experience (PE) Initiative seeks to facilitate and accelerate the industry’s progression towards a future where the patient experience is enhanced in clinical trials and patient burden is reduced.
The eConsent Initiative will create a common approach for the electronic consenting of patients using an array of digital elements and process efficiencies to increase insight into patients’ understanding, increase regulatory compliance, and reduce quality risks.
The TransCelerate eLabels initiative will help the industry progress on the journey to digitally supported, patient-centric clinical supply chains.