The Patient Technology Toolkit and
Associated Assets

The Patient Technology Initiative aims to enable and accelerate the adoption of patient-facing digital technologies (PT) in clinical trials. Based on research published in the Patient Technology white paper, the Patient Technology Toolkit was developed.

Open for Comment: The Patient Technology initiative is seeking vendor feedback by December 16, 2019 on their PT Vendor and Sponsor Engagement Considerations. All feedback is kept anonymously and should be sent directly to feedback@transceleratebiopharmainc.com.

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 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

How is the Toolkit Used?

Navigate Jim's use of the toolkit by clicking on the icons for each step.

Jim

Jim is interested in using a digital patient-facing technology in his oncology trial. He needs to understand:

  • General implementation considerations
  • Internal/External Stakeholder Management
  • Regulatory considerations
Implementation Framework
PT Discussion Guide
Share Information

Jim first uses the Implementation Framework to help him understand the end-to-end process, develop strategy, identify potential risks, and plan for implementation.

He then uses the PT Discussion Guide to help engage with and ensure appropriate communication with internal and external stakeholders.

He consults the Regulatory Landscape Tool to understand the potential regulatory impact on his project.

Jim then returns to the Implementation Framework to ‘de-risk’ technologies and implementation strategies through rapid, iterative testing.

During the trial, Jim uses the PT Site Feedback Questionnaire to learn from sites how implementation could be improved in the future.

Finally, Jim shares his learnings and repeats the process to improve and scale future PT implementation.

Regulatory Landscape Tool
PT Site Feedback Questionnaire
Implementation Framework
Implementation Framework

Jim first uses the Implementation Framework to help him understand the end-to-end process, develop strategy, identify potential risks, and plan for implementation.

PT Discussion Guide

He then uses the PT Discussion Guide to help engage with and ensure appropriate communication with internal and external stakeholders.

Regulatory Landscape Tool

He consults the Regulatory Landscape Tool to understand the potential regulatory impact on his project.

Implementation Framework

Jim then returns to the Implementation Framework to ‘de-risk’ technologies and implementation strategies through rapid, iterative testing.

PT Site Feedback Questionnaire

During the trial, Jim uses the PT Site Feedback Questionnaire to learn from sites how implementation could be improved in the future.

Share Information

Finally, Jim shares his learnings and repeats the process to improve and scale future PT implementation.

POV Paper
POV Paper

In our white paper, the PT Initiative describes the potential for patient-facing digital technologies (also called “Patient Technology”) to serve a variety of functions in clinical trials, such as capturing clinical endpoints, engaging patients, and facilitating remote study conduct. However, these technologies are not yet accepted as mainstream research tools.

To understand the barriers and facilitators affecting PT adoption, the TransCelerate Patient Technology Initiative conducted a series of surveys, interviews, and focus groups with approximately 600 subject matter experts (SMEs), including pharmaceutical company representatives, clinical trial investigators, and clinical trial participants. We identified several challenges that were common across the industry and outlined several recommendations to address them.

Download now—Accelerating Adoption of Patient-Facing Technologies in Clinical Trials: A Pharmaceutical Industry Perspective on Opportunities and Challenges

Implementation Framework

The Implementation Framework outlines a possible approach to Patient Technology implementation that encourages a mindset of strategic thinking, rapid learning, and patient-centric design. It can be used by study or strategy teams to:

  • Get started or move forward with PT implementation 
  • Incorporate an iterative, rapid-learning approach to PT
  • Consider patient and site perspectives during program design
  • Enable PT programs to build toward a company’s unique strategic vision
  • Mitigate common risks associated with PT implementation

For additional information, see our Implementation Framework FAQs.

Please share your feedback and experience here to help us make future improvements.

 

PT Discussion Guide

The Discussion Guide provides a list of core questions to consider during the implementation of PT in clinical trials. It enables users who are new to PT to identify risks, ask the right questions, and engage relevant stakeholders early in the PT evaluation and implementation​ process. The guide covers considerations related to:

  • Budget & Resourcing
  • Feasibility & Quality
  • Legal & Regulatory
  • Process & Strategy
  • Scalability & Support
  • Site Impact
  • Technology & Infrastructure

The Discussion Guide can be accessed as a standalone tool or as an integrated supplement to the Implementation Framework.

Please share your feedback and experience here to help us make future improvements.

Regulatory Landscape Tool

The Regulatory Landscape Tool provides an overview of US and EU Health Authority regulation and guidance related to digital technologies and their use in clinical trials. It covers:

  • Medical device classification and associated requirements
  • Related regulations and guidance pertaining to clinical trial conduct
  • Pathways for obtaining Health Authority feedback
  • Policies and initiatives that might reflect or impact Health Authority positions on use of digital technologies

For additional information, see our Regulatory Landscape Tool FAQs.

PT Site Feedback Questionnaire

The PT Site Feedback Questionnaire captures actionable feedback on sites’ experiences with patient-facing technology and sites’ impressions of patient experience using technology over the course of a clinical trial. This structured feedback tool can help:

  • Identify and mitigate potential issues as the study progresses
  • Inform future study design based on user feedback
  • Accelerate adoption of the same or similar patient-facing technology(ies)

For additional information, see our Sponsor User Guide.

Please share your feedback and experience here to help us make future improvements.