The Patient Technology Initiative Solutions
The Patient Technology Initiative aims to enable and accelerate the adoption of patient-facing digital technologies (PT) in clinical trials. PT presents opportunities to transform drug development and the patient experience. New or improved measurements for known and novel endpoints are foundational to the opportunities of PT. To highlight the importance of this opportunity, the Patient Technology Initiative published the Novel Digital Endpoints Validation Pathway Paper in Digital Biomarkers. This peer-reviewed paper provides a use case proposal and considerations when developing and obtaining regulatory acceptance for a novel digital endpoint to assess sleep in patients with rheumatoid arthritis (RA)
To encourage patient-centric collaboration in the space, the Patient Technology Initiative also completed a first of its kind exercise in knowledge sharing. Leveraging TransCelerate’s membership, the initiative team collected member company experience implementing PT in clinical trials. The resulting insights and findings from that knowledge sharing exercise can be found in a team-authored white paper, “A Shared Perspective of Patient Technology Implementation in Clinical Trials.”
To further assist the goal to enable and accelerate the adoption of PT in clinical trials, the Patient Technology Toolkit was developed. This Toolkit was developed based on foundational research published in the Patient Technology manuscript.
What problems are we trying to solve?
Though the potential benefits of using PT are widely discussed, they are not yet fully realized because:
- A variety of regulatory, technical, cultural, and operational obstacles make it difficult for sponsors to progress novel PTs from pilot phase to scale
- Lack of communication between stakeholders (both internal and external) limits learning over time, resulting in sub-optimal PT implementation
- Risks and unknowns associated with PT may be overwhelming and study teams often struggle to navigate them
The Patient Technology Toolkit was designed to:
- Help decision-makers and study teams approach PT implementation strategically with long-term goals and scalability in mind
- Facilitate the flow of knowledge and feedback between internal and external clinical trial stakeholders with respect to PT
- Help study teams identify, prevent or mitigate potential risks associated with PT adoption
Not Sure Where to Get Started?
- Check out these common scenarios identified by clinical study teams, and how the toolkit can be leveraged to address technical challenges