Telemedicine represents ‘next significant change’ in rheumatology clinical trials

Optimal trial participation is an key goal not only for researchers and pharmaceutical companies, but drug development as a whole, but travel requirements can often exclude certain patients with rheumatic diseases before they even begin.

In fact, patients with autoimmune and rheumatic conditions may be more negatively impacted by on-site clinical trial requirements than most. Regular and debilitating pain, limited mobility and strict therapy regimens can make traveling to clinical trial sites and participating a difficult task.

According to Lewis Millen, global clinical sciences and operations innovation lead at UCB, the use of remote participation and telemedicine technology for clinical trials may be a potential answer.

“The emergence of COVID-19 catalyzed the adoption of decentralized approaches in clinical trials,” he said. “Through remote visits, monitoring and data collection, these hybrid trials minimized disruptions and enabled the progression of trials even when physical access to trial sites was restricted or prohibited. We learned valuable lessons during this period that are expected to have long-lasting impacts on the design and execution of clinical trials, providing patients with the opportunity to participate in trials even when presence is not feasible.”

Healio recently sat down with Millen to discuss the future of remote participation in clinical trials, its possible expansion in rheumatology and the importance of a more diverse participant population.

Healio: Can you explain the concept of a hybrid trial?

Millen: Hybrid clinical trials are a unique form of clinical trial that combines aspects of traditional, on-site trials with remote activities. In hybrid trials, we leverage digital tools, services and technologies as much as we can, as well as integrate community health care, and combine this with physical trial sites for activities that require in-person involvement.

By integrating decentralized elements into clinical trials, the hybrid approach merges the convenience of remote and virtual options with the necessary components of traditional trials. The aim is a better trial experience and optimized results for both patients and researchers.

Millen: Hybrid clinical trials can hold significant benefits for patients with rheumatic diseases, such as psoriatic arthritis, axial spondyloarthritis or rheumatoid arthritis. Individuals living with these conditions often experience a substantial burden of pain, fatigue and functional challenges that directly impact their quality of life.

By incorporating remote and decentralized elements, hybrid trials can provide patients with greater access to participate in clinical studies. This accessibility empowers patients by reducing barriers such as travel burdens, allowing them to contribute to research regardless of their geographical location. As a result, the study population becomes more representative of the broader patient community, leading to results that should be more reflective of real-world patient experiences and needs.

Furthermore, the hybrid trial model may promote faster generation of results. By leveraging digital tools and remote data collection, researchers can gather information in real-time, leading to more efficient analysis and decision-making. This accelerated timeline ultimately benefits patients by expediting the development and availability of potential treatments and interventions as well as reducing time to diagnosis.

Healio: What does the concept of hybrid trials bring to trial accessibility?

Millen: When deciding whether a trial can be performed in a hybrid way, we first look at the disease and its impact on patients and their families and caregivers, to understand the opportunities and challenges decentralized clinical trial methodology and approaches might bring.

Our aim is to make clinical trial participation as easy as possible, enabling participants and their families to continue with their day-to-day lives with minimal disruption. On days when patients need more flexibility due to the demands of their jobs, family commitments, and aspects of their conditions, we endeavor to offer a home option. By removing such barriers, more patients have access to participation in clinical trials.

Healio: How are hybrid trials more conducive to receiving patient-reported outcomes (PROs)?

Millen: Remote data capturing methods allow participants to provide PROs from their homes or local environments, allowing easier and more frequent data collection, enabling a comprehensive understanding of patient experiences throughout the trial. This increased engagement can result in more comprehensive and reliable PRO data.

Additionally, hybrid trials sometimes gather PROs in real-time. Patients can use mobile apps, wearable devices, or web-based questionnaires to report their outcomes promptly, providing timely and accurate data for analysis.

Healio: How do hybrid trials increase diverse patient populations in rheumatology trials?

Millen: Rheumatic diseases can affect diverse populations that may be historically underrepresented in clinical studies. To make our solutions relevant to the individual needs of each patient, it is essential to ensure that clinical trials are inclusive of the diverse communities we serve and address a wide range of unique situations experienced by each patient.

By providing increased choices, we can broaden the participation of patients from diverse communities, various age groups, and even remote locations throughout the clinical trial process. We endeavor to bring tailored — eg, provisioned — devices as an option vs. “bring your own device” or BYOD, which could be important from a socioeconomic perspective, with some patients not having access to a phone.

This approach aims to empower a greater number of people to take part in trials, and therefore allow the diversity of the communities that we serve to be reflected in the solutions that we develop.

Healio: What kinds of technology have been beneficial for the advancement of hybrid trials?

Millen: We are leveraging innovative technology to pilot and deploy remote patient-centric sampling and data capture solutions, such as PK blood sampling, and non-invasive skin biopsies and imaging. We are continually looking to expand what is possible in the home. However, there will always be some tests that need to be performed in a clinical setting, such as invasive biopsies, which is why a hybrid clinical trial model uses the best of both the remote and clinical approaches.

We are constantly motivated by and driven to support the large number of patients affected by rheumatic diseases — a goal made possible through our meaningful and trusted partnerships. In addition to the at-home testing solutions, we are delivering scalable digital solutions for clinical trials through our partnership with Veeva Systems, the cloud-based software used by life sciences companies. This partnership will see UCB adopt Veeva ePRO and Veeva eConsent to provide a patient-centric digital experience to study participants, and will actively influence the strategic direction of these and other applications.

Together, Veeva Systems and UCB aim to set a new industry standard for digital clinical trials with multiple applications that meet the unique needs of patients.

Healio: Has UCB received any kind of feedback regarding hybrid trials? If so, what kind of feedback?

Millen: We have actively sought feedback through various channels. For patients, we use a standard patient experience survey across our studies, which provides us with net promoter score (NPS) data. Although this survey is general and high-level, it helps us gauge overall patient satisfaction. In some cases, we include “innovation” questions within the survey that relate to specific solutions, such as telemedicine or home nursing, rather than hybrid trials specifically.

Although we have received feedback through these channels, it is important to note that the focus of feedback has been on the specific solutions use in the trials, rather than solely on hybrid trial design itself. This feedback helps us identify areas of improvement and tailor our approaches.

Healio: Is there any kind of advancement you would like to see to make these trials more feasible?

Millen: Looking ahead, I expect that hybrid trials will continue to grow in prevalence and evolve in their design and execution, to provide more flexibility and increased personalization for patients. It is difficult to say exactly where this will take us, but technological advancements will continue to drive innovation in what types of data can be collected remotely.

Currently, we are leveraging cutting-edge technology to aid in patient monitoring and sample collection. As technology becomes more advanced, we may be able to conduct more and more complex tests from the comfort of our own homes. AI may also have a part to play in predicting patients’ needs and flexing around those.

Hybrid trials have the potential to generate real-world evidence by capturing data in more naturalistic settings. Real world evidence can complement traditional trial data by providing insights into the long-term effectiveness and safety of interventions in real-world patient populations. This can further support regulatory decision-making and post-market surveillance.

Overall, given the benefits they offer and the supportive trends in the clinical research landscape, it is anticipated that hybrid trials will become increasingly prevalent and play a significant role in advancing clinical research in the coming years.

Healio: Is there a place for clinic-only trials in the future? If so, what is it?

Millen: Each trial is unique, and the requirements of each clinical trial must be assessed on their own merits. Activities that involve direct physical examinations, invasive procedures, or technology only available in a hospital are better suited for a clinical setting where health care professionals can ensure proper execution and patient safety. We should also not lose sight of the importance of human contact and care.

Healio: What is your prediction for the next big change in the way clinical trials are conducted in rheumatology?

Millen: The next significant change in the way clinical trials are conducted in rheumatology will increasingly revolve around leveraging digital technology for more patient-centric studies. Remote monitoring and telemedicine assessments will continue to evolve rapidly, offering greater convenience and accessibility to patients. This shift will enable more frequent and real-time data collection, leading to a comprehensive understanding of patient experiences and treatment outcomes.

Another area where we anticipate a substantial change is the use of large datasets to develop historical control or synthetic control arms for clinical studies. This approach will be particularly valuable in situations where it is ethically or practically challenging to assign participants to a placebo arm. By using real-world data, we may establish comparative arms that are both relevant and informative. This innovation will enhance the feasibility and efficiency of clinical trials, accelerating the development of new therapies while maintaining rigorous scientific standards.

Overall, the integration of digital technology and the use of large datasets hold great potential to transform the landscape of clinical trials in rheumatology. These advancements will bring us closer to patient-centered research, providing more accurate, efficient and ethically robust approaches to evaluating new treatments and improving patient outcomes. Our goal is to remove roadblocks on the patient journey and to provide patients with the best experience.