Patient-facing digital technologies (PT) include any digital technology, such as software, wearable devices, and sensors, that patients interact with to participate in healthcare or clinical trials. When implemented effectively, these technologies can help facilitate data collection, increase access to timely, quality care, and may even improve the patient experience.

The rise of PT is not new; however, their incorporation into clinical trials is still not fully explored and is laden with logistical obstacles. The marriage between clinical trials and PT could potentially enable broader patient participation, improve outcome measures, and facilitate the collection of real-world data. Although the benefits of implementing PT in clinical studies are evident, PT has yet to make a clear entrance into the clinical arena, as many trials continue to rely on traditional research methodology.

Initiative Addresses Barriers To Adoption Of PT

Despite a level of uncertainty with PT implementation, there is growing interest in its use in clinical trials, especially as it pertains to reducing patient burden. To better understand the factors involved in PT adoption, the TransCelerate Patient Technology Initiative team conducted a series of questionnaires, interviews, and surveys with 600 subject matter experts, including pharmaceutical company representatives, clinical trial investigators, and clinical trial participants. There was general consensus around the potential value of patient-facing technology as a clinical research tool, though a variety of barriers faced by each stakeholder were identified.

According to respondents, both organizational and external challenges are preventing a wider adoption of PT in clinical trials. Organizational difficulties include averse corporate culture, regional differences in technological use, and the added costs and risks involved in changing processes. Corporate culture can be a pain point due to the varying pace at which technology is being developed across the world. There are also regional differences in the interpretations, thoughts, and approaches around technology, which makes its adoption more 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 financial expenses, integration of multiple data streams, and establishing effective communication among all involved stakeholders. Regulatory uncertainty comprises some of the external challenges to implementing PT, such as disparities in regional, technological, and patient guidelines, all of which can have an individual and compound effect on PT enactment.

In response to the pain points and insights outlined from study subjects, TransCelerate’s Patient Technology Initiative was born. The initiative has been focused on developing the tools needed to help spur greater collaboration and knowledge sharing among players in the clinical research ecosystem.  Recently, the Patient Technology Toolkit was developed for industry stakeholders and is designed to serve as an efficient framework for enabling the implementation of PT in clinical trials. It helps identify and prevent potential risks to PT adoption and streamlines communication between internal and external stakeholders. The toolkit also helps keep scalability and long-term goals in the minds of decision-makers and clinical study teams. A virtual user journey of this resource is available, as well. It is designed to help navigate implementing patient technology from conception through execution of the trial.

While the toolkit 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. For example, the PT Discussion Guideoutlines a list of key questions that could be considered during the implementation and adoption of PT. It enables users who are new to PT to identify risks and engage relevant stakeholders early in the PT evaluation and execution process. Another widely beneficial asset, the Regulatory Landscape Tool, helps stakeholders navigate the regulatory space and provides actionable advice for approaching regulatory authorities about PT.

Resources are available to support the relationship between sponsors and suppliers, too. The need to improve the partnership between sponsors and vendors is evident, as TransCelerate’s primary research shows that over 90 percent of PT deployed in clinical trials is externalized and/or co-developed with vendors. Thus, the Patient Technology Vendor and Sponsor Engagement Considerations were developed along with vendors to facilitate more routine two-way feedback discussions between sponsors and vendors on the deployment of PT in clinical studies. The document provides a list of core questions by topic to think about with a vendor during and after the implementation of PT in clinical trials. This helps enable learnings to be shared, documented, and leveraged by both parties for future studies.

PT’s Benefits For Stakeholders

Incorporating patient technology into clinical trials is expected to deliver benefits to patients, investigator sites, regulators, sponsors, and clinical research organizations (CROs). On a micro level, opportunities for improvement include increased trial efficiency, decreased patient burden, and a better patient experience. Slightly broader, richer data collection and improved patient insights are potential benefits for clinical research investigators. On a macro level, the Patient Technology Initiative could help CROs and regulators understand current administrative implications on the use of PT as well as develop a framework for using digital means more effectively in the future.

One of TransCelerate’s other initiatives — eConsent — is a strong example of the benefits of PT in action. Using patient-focused multimedia technology, eConsent has transformed informed consent 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 apprised. The use of PT to consent patients allows for flexibility in learning styles, greater accessibility, and informed conversation between the investigative staff and participant. While eConsent is an excellent instance of how PT can effectively transform the clinical trial process, there is more work to be done to realize the full potential of PT within the realm of clinical studies.

Overall, it is clear that interest in the use of PT in clinical research is mounting, as PT poses opportunities to engage with patients in new and exciting ways. With the use of digital solutions in the biopharmaceutical industry on the rise, it’s more important than ever to understand how to apply PT in support of improved data gathering and patient-centricity. As technology continues to evolve, the industry must evolve with it to maintain relevancy as these advancements occur. TransCelerate’s Patient Technology Initiative is a good starting place for these efforts, but collaboration among the relevant stakeholders offers a unique opportunity to shape the future of PT adoption and improve the trial process for all industry stakeholders.

Are your oversight procedures in place?

Recent updates to ICH GCP E6 recognize the increase in remote clinical trials and outlines expectations for Investigator Oversight. Check out Sandra “SAM” Sather’s webinar, “Investigator Oversight Plans: Essentials for Inspection Readiness Post ICH GCP E6 (R2) Addendum

About the Author:

Peter Schaeffer has worked in the pharmaceutical industry for approximately 20 years, in both the preclinical and clinical areas. During this time, he has worked in roles to improve performance and decision making, led continuous improvement programs, and collaborated with teams to drive new ways of working. In his current role of analytics director in third-party risk and oversight at GlaxoSmithKline, Schaeffer is focused on implementing new ways of working and tools to improve supplier oversight for R&D programs. He has also taken a leading role in implementing patient technology at TransCelerate. Leading the PT workstream aligns with his passion of improving patient experience and accelerating clinical trials. He earned a BS and an MBA from Penn State University and is certified in project management.

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