The evolving landscape of clinical trials: Using technology to enhance patient and HCP involvement

• Remote and decentralized trials are bridging the gap between healthcare delivery and research
• New roles within clinical trials offer an opportunity to increase patient involvement and satisfaction without impacting financial budgets
• Traditionally, clinical trials have posed formidable challenges for patients, with difficult logistics and limited accessibility

The future of clinical trials is changing and it is marked by a determined effort to enhance patient engagement and the adoption of cutting-edge technology, resulting in new opportunities for healthcare providers (HCPs) to actively participate in these pivotal medical endeavors.

With an increased focus on patient experience and needs, shifting to remote and decentralized trials could help to boost patient involvement in clinical research.  As researchers move forward, it will be important they leverage new technology to collect data and ensure data security.

In part 2 of our interview, Craig Lipset explains how the clinical trial landscape is evolving and how technology can be used to enhance patient engagement and enable HCPs to contribute to research. This transformation promises to reshape the future of clinical trials and advance medical progress for the benefit of all.

HT: What should healthcare executives be focusing on when it comes to embracing and benefiting from new and innovative approaches to collecting clinical trial data?

Craig Lipset:  Data reveal compelling insights into the positive impact of patients engaging in clinical research. This engagement is associated with several key benefits, including improved outcomes, reduced healthcare costs, and heightened patient satisfaction.

The significance of these improved outcomes goes beyond the direct effect of introducing a new drug or intervention. Patients participating in research studies enjoy enhanced access to their care teams, leading to increased interactions with investigators and study coordinators compared to their interactions with regular healthcare providers. The high levels of satisfaction and support from patients who participate is a trend that has been evident for years.

This not only improves patient satisfaction but also often results in a lower cost of care for research participants. This isn’t solely due to cost-shifting, where pharmaceutical research sponsors cover certain expenses. Instead, it appears to be linked to this increased access and engagement patients experience with their care teams, and how their care is managed.

HT: What does this mean for healthcare executives?

Craig Lipset: For healthcare executives, these findings hold significant implications. Many executives, particularly in the United States, are keenly focused on achieving the triple aim:

• improving outcomes
• lowering healthcare costs, and
• enhancing patient satisfaction.

Clinical trials are emerging as a valuable non-dilutive strategy to support these aims.

When patients are eligible for clinical trials, they can receive additional attention and support from their study teams that seem to improve outcomes and meet other triple-aim objectives without hitting the healthcare executive’s budget, which is of particular relevance to physicians in the US. Sponsored research studies often subsidize these resources as part of their program.

This shift in strategy offers an intriguing opportunity for healthcare executives who may have previously viewed clinical trials as burdensome to their systems or disruptive to their standard care processes. Now, data suggests that savvy executives can strategically leverage clinical research participation to advance their triple aim goals, ultimately improving outcomes, reducing costs, and increasing patient satisfaction at a population level.

HT: Current fee-for-service models limit the ability of private care providers to be involved in clinical trial data collection. What needs to change to make sure healthcare providers can also be trial investigators and that they’re remunerated for their services?

Craig Lipset: Historically, clinical trials have predominantly offered two avenues for healthcare providers, physicians, and others to participate: either as investigators or by referring patients to research sites.

Being an investigator in a clinical trial carries significant responsibilities and oversight, often proving impractical for many physicians due to its demanding nature. The additional responsibilities, including monitoring by study teams and regulatory inspections, limit research participation to a select few healthcare providers.

The alternative of referring patients to external research studies can also be problematic, especially in the fee-for-service healthcare model, where it is viewed negatively as a patient leaving a healthcare practice, also known as patient leakage.

In response, innovative models like Integrated Research Organizations (IROs) have emerged. These organizations partner with medical practices to simplify the process of becoming an investigator by bringing study staff, established Standard Operating Procedures (SOPs), quality frameworks, and systems into the practice environment.

Even with these innovative models, some physicians may still find the investigator role burdensome. Recent advancements in video and decentralized research approaches open up a third option. Healthcare providers can now host research visits within their practices while focusing on routine care activities. Video technology allows study staff to remotely monitor patient interactions, ensuring proper oversight. Additionally, patients can visit local laboratories, imaging centers, or community providers for certain study-related activities that are considered consistent with routine care, with these providers compensated fairly for their contributions.

This emerging third option strikes a balance, allowing healthcare providers to contribute to research without the full responsibilities of being an investigator or referring patients away from their practices. Regulatory authorities, including the FDA, are recognizing these innovations. Earlier this year, the FDA released its draft guidance on decentralized clinical trials. This document acknowledges the evolving role of healthcare providers in research, marking a significant development in this area.

HT: What do we need to move forward with virtual and remote clinical trials and how do we ensure patient privacy and security are protected as we make clinical trials more accessible?

Craig Lipset: The tools and input we need to move forward with remote and decentralized clinical trials while ensuring patient privacy and security are protected as we make clinical trials more accessible can be summarized as follows:

Flexibility: Remote clinical trials, or decentralized clinical trials, need to be able to leverage technology and smart new innovative processes while enabling people to participate in research without needing to travel to a research site for all visits.

These types of studies create flexibility in how and where people can participate. They’re not meant to prevent people from seeing their provider or seeing an investigator. Many patients tell us they prefer seeing an investigator at certain times of their patient journeys.

What these strategies and approaches should do is create flexibility and options for patients, so that they can visit the clinic when it makes sense or when a protocol visit absolutely requires it. This way they have flexibility for those other visits based on their own journey and needs as human beings.

Decentralized approach: Prior to the pandemic, we saw a fair amount of experimentation with decentralized research approaches. During lockdowns, patients could not go to a medical clinic, and many providers experienced capacity constraints. These types of decentralized approaches proved to be an important countermeasure for continuous medicine development globally. Leveraging remote monitoring, telehealth, home visits, and other strategies were all part of that solution.

Streamlined processes: Pharmaceutical companies, research sponsors, and research sites around the world rose to the challenge, modifying and enhancing their processes to implement these new approaches aggressively.

Some of that adoption spike may feel like it’s stalling because of regulatory ambiguity. Will regulators around the world continue to support these approaches post-pandemic as they did during the pandemic?

Sustainability: Regulators are taking strong global leadership positions by introducing guidance documents, recommendations, and other position papers that spell out their expectations for using decentralized methods in clinical trials following the pandemic. We’ve seen this in recent months from the FDA (Food & Drug Association), the European Medicines Agency (EMA), and other agencies globally.

Collaboration: Collaborations like the IMI Trials@Home program in Europe¹, TransCelerate² among pharmaceutical companies, and the Decentralized Trials Research Alliance³ as a multi-stakeholder global collaboration, all of these and so many others are working together to address the challenges that research stakeholders face when trying to make trials more accessible for patients.

Privacy considerations: Consider privacy when introducing tools and approaches to decentralized research. From visiting nurses and home health providers entering people’s homes to video encounters with certain things in the background that we might not ordinarily have access to location tracking – everything has to protect the privacy of patients.