Patient-facing digital technologies have the potential 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, and the opportunities, challenges, and facilitators associated with their implementation in clinical trials have not been fully characterized.
TransCelerate has undertaken a Patient Technology Initiative with the objective of enabling and accelerating the use of patient-facing digital technology in clinical trials. We spoke to Alison Bond, Director of Global Regulatory Policy & Intelligence at Janssen and who is working on the Patient Technology Initiative, about how technology can improve clinical trials.
What are the most powerful ways that technology can enhance the patient experience?
Digital technology has the potential to greatly transform the patient experience in two key aspects: firstly, enhanced patient experience and engagement during the conduct of a trial. Technology can reduce the burden on patients, for example by reducing the number of procedures or visits and integrating study activities into patients’ daily lives. Secondly, the use of patient technology offers opportunities for increased data quality and better insights. Data can be collected in real time, which can provide more meaningful, richer datasets, leading to improved clinical trial outcomes and decision-making.
What are the biggest challenges pharma companies are facing in full-scale implementation of patient technology in trials?
Early research conducted by our team and published last year indicated a few key themes; organisational challenges (e.g. corporate culture of risk aversion), business-related challenges (e.g. impact on budget), external challenges (e.g. maturity of the technology landscape), and regulatory challenges (e.g. lack of specific guidance). More specifically, the top three barriers to full scale implementation of patient technology were perceived to be cost (and return on investment that may only be fully realised once technologies are implemented at scale), regulatory implications, and an increase in site burden.
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What are the biggest changes needed in the industry that you think will drive wide-spread adoption of patient technology in clinical trials?
Implementation of patient technology requires input from a wide range of stakeholders, including vendors, sponsors, sites, patients, and regulators. To drive wide-spread adoption of patient technology, there needs to be greater dialogue between all stakeholders to develop solutions to overcome the challenges, and an openness to sharing experiences so that we can learn from each other and not make the same mistakes.
Tell us about the Patient Technology Initiative? How does it facilitate and accelerate the use of patient-facing digital technology in clinical trials?
The Patient Technology Initiative involves a group of approximately 35 individuals from 15 different pharmaceutical companies who have joined together to help enable and accelerate the use of patient-facing digital technology in clinical trials. We centre our work around 1) creating processes, methodologies and considerations for optimised technology use and an efficient approach to PT adoption and scalability, 2) sharing data and learnings to reduce re-learning, and 3) creating understanding between health authorities and industry stakeholders on the use of patient technology.
The Patient Technology team is releasing tools in July - can you offer any details on them and how they will help the Patient Technology Initiative?
As mentioned before, our primary research and subsequent publication highlights key themes impacting the implementation and adoption of patient technology. To address the key challenges that emerged, our Patient Technology team has developed a set of tools that are intended for use by different stakeholders (e.g. sponsors, sites, etc.) as aids in the implementation of patient technology. Four tools are to be released during the last week of June:
- Patient Technology Implementation Framework: A framework outlining a possible approach to patient technology implementation that encourages a mindset of strategic thinking, rapid learning, and patient-centric design.
- Patient Technology Discussion Guide: A list of core questions to consider during the implementation of patient technology in clinical trials, enabling users to identify risks, ask the right questions, and engage relevant stakeholders.
- Regulatory Landscape Tool: An overview of US and EU regulation and guidance related to digital technologies and their use in clinical trials.
- Patient Technology Site Feedback Questionnaire: A concise questionnaire that can be used to capture actionable feedback on sites’ experiences with patient technology and sites’ impressions of patient experience using technology over the course of a clinical trial.
Alison Bond is presenting a case study of TransCelerate's Patient Technology Initiative at Clinical Trials Europe in Barcelona on 20 November. Explore the full agenda here.