The rise of patient-facing digital technologies (PT) is not new, however, their incorporation into clinical trials is still unexplored and laden with logistical obstacles. The marriage between clinical trials and PT could potentially improve the patient experience and outcome measures, encouraging remote participation and facilitating the collection of real-world data. Although the benefits of implementing PT in clinical trials are evident, PT has yet to make a clear entrance into the clinical arena. This challenge led TransCelerate to create the Patient Technology Initiative, which aims to enable and accelerate the adoption of PT in the clinical research ecosystem.
Q: Please describe what patient-facing digital technologies (PT) are.
A: Patient-facing digital technologies cover a broad area and include any digital technology, such as software, wearable devices and sensors, that patients interact with to participate in health care or clinical trials. These technologies can help facilitate data collection, increase access to timely, quality care and improve patient experience.
Q: What were the challenges, inconsistencies and pain points that led to the development and/or ideation of the Patient Technology Initiative? How is the initiative helping to solve those challenges?
A: A top challenge associated with PT is navigating the regulatory landscape. Regulations tend to vary by region and the type of device that’s used, which can create challenges with PT uptake and implementation. The application of technology can also lead to difficulties. As a mainstay in most people’s personal and professional lives, technology can facilitate many tasks and interactions, but when it doesn’t work, challenges can easily arise. This inherent, uncertain nature of individuals’ experiences working with technology can increase the complexities of implementation.
Corporate culture can be an additional pain point, particularly when there is a different pace at which technology is being developed presently in the world as well. There are also regional differences in the interpretations, thoughts and approaches around technology as a whole. This can become especially difficult when determining how to manage and develop effective policy for issues like the privacy of personal information and data. Lastly, there are several operational concerns around deploying technology in clinical trials, such as added costs, integration between multiple data streams, and risks involved in changing process, as well as establishing effective communication among all involved stakeholders.
Our team’s work on the Patient Technology Initiative has been focused on developing the tools needed to help demystify some of these challenges. Based on insights and knowledge received from TransCelerate Member Companies, we’ve been able to produce a framework that highlights the PT regulatory landscape, patient considerations to keep in mind when using these technologies, how to work appropriately with vendors, and more. While the framework can be used in full, it can also be broken down into individual components so that stakeholders can use the pieces that are most valuable to them. Overall, this package of resources helps manage the regulatory and operational barriers that have historically complicated the PT process.
Q: Where does this initiative deliver the most benefits?
A: This initiative has benefited a variety of additional industry stakeholders, including Clinical Research Organizations (CROs), investigator sites, patients and regulators. We’ve engaged and developed tools to better support all of these players. For example, our regulatory assets, like the Regulatory Landscape Tool, help stakeholders navigate the regulatory space related to digital technology and evaluate how to approach regulatory authorities with PT. The site engagement tools are important, too, and encourage sites to provide actionable feedback on their own experiences with PT and their impressions of the patient experience over the course of a clinical trial. This not only allows sites to more easily share their input with sponsor companies, but also helps ensure their feedback is acted upon. Ultimately, this initiative delivers benefits that encompass the whole PT journey, from industry to patients to sites and to vendors, with the goal of facilitating PT use and adoption for each of these stakeholder groups.
One of TransCelerate’s other initiatives – eConsent – is an example of PT that uses patient-focused multi-media technology that has transformed the informed consent process for participants in clinical trials. Informed consent has traditionally been a laborious process with complex language and complicated study designs, which are barriers that can keep patients from being fully informed. The use of PT to consent patients allows for flexibility in learning styles, greater accessibility and informed conversation between the investigative staff and participant. Similar to eConsent, we hope that the Patient Technology Toolkit will improve the quality and efficiency of clinical trials.
Q: Tell us about the new Patient Technology Toolkit as well as the other resources that are available for this initiative.
A: The Patient Technology Toolkit is designed for industry stakeholders as a framework on how to implement patient technology in clinical trials. It is based upon the findings from the Patient Technology whitepaper, which highlights the hurdles in PT adoption as previously discussed. The PT Toolkit helps identify and prevent potential risks to PT adoption and streamlines communication between internal and external stakeholders. It keeps scalability and long-term goals in the minds of decision-makers and clinical study teams, as well.
The Toolkit is constantly evolving; for example, we developed the PT Discussion Guide last year as a way of organizing key questions for companies interested in adopting PT to consider. Most recently, we have added a complementary resource, Patient Considerations, that is organized similarly to the Discussion Guide, but with questions focused on the patient perspective that are important to give thought to when employing PT in a clinical study.
One final thing to keep in mind is that we have also designed a virtual journey to help navigate the Patient Technology Toolkit. Visitors can click here and scroll to “How is the Toolkit Used,” to access the different stages of implementing PT in clinical trials through the lens of a character we’ve called Jim. Jim is a researcher who is looking to incorporate PT into his oncology trial. By following along with Jim’s navigation of the PT Toolkit, we hope users will feel more organized as they navigate the Toolkit themselves.
Q: How can readers help to improve the Patient Technology Toolkit as well as the initiative, more broadly?
A: Industry feedback is critical for making continued improvements to the Patient Technology Initiative, including the Toolkit. We are hoping that study teams, decision-makers, and patients will review the initiative and the resources available, and we appreciate any thoughts, suggestions, and advisement. Users can share their feedback by clicking this link: https://transceleratebiopharmainc.com/patient-technology-implementation-framework/patient-technology-assets/pt-feedback-input-page/.