Post-COVID-19 Clinical Trials: Finally Understanding The Meaning Of Patient-Centricity

By Todd Johnson and Hannah Yee, Halloran Consulting Group, Inc.

Much of the daily news focus is on the race to produce vaccines and therapies to combat the spread of COVID-19. While this work is undeniably important, we must not lose sight of what keeps our industry running: the patients we serve. Despite being instrumental to our mission of making lifesaving therapies accessible to all, patient perspectives are far too often lost in the wake of “flashier” news about approvals, supply chains, and scientific breakthroughs.

Halloran’s latest COVID-19 Virtual Town Hall convened patients and patient advocacy experts for a discussion about how the very people we seek to serve are experiencing the pandemic. Patient-centricity has been a buzzword in industry circles for quite some time now, with sponsors equating it to either reduced protocol assessments or increased use of technology in trials — but can a trial truly be patient-centric without obtaining direct input from the patient to begin with? Our industry has a lot to learn about patient-centric trials, but giving patients a voice will help us better understand their concerns, needs, and hopes so we can do our jobs better both during COVID-19 and after it loosens its grip on the world.

Patients’ Perspectives On Participating In Clinical Trials During COVID-19

General patient concerns during this crisis include supply chain and drug shortages; stress around maintaining personal drug inventories while navigating the logistics of coordinating shipments, sitting on hold on pharmacy phone lines, and adapting to a rapidly changing environment with little visibility into the rationale for those changes; the onus of “project managing” their treatment; blood shortages and donor matches; home health aides entering patients’ personal space with limited personal protective equipment (PPE); trial delays/de-prioritization (especially among rare disease patients); and fear that therapies may become unavailable or that trials will be paused.

To address these concerns, sponsors can adopt a variety of strategies.  First, do not assume patients want trials to stop or that patients don’t want to come on-site. Maintain a close connection with patient communities and with individual patients — these relationships are especially paramount during these times. Over-communicate and over-engage with patients to keep them updated with the latest news on the status of their trial and any forthcoming changes of routine. Finally, actively engage with sites to better understand any creative solutions they may have implemented to mitigate patients’ burdens and alleviate anxiety.

Patients’ Perspective On Participating In Clinical Trials After COVID-19

Generally, patients agree that the introduction of virtual visits and remote capabilities is long overdue and very exciting. There’s hope within the patient community that these solutions will endure into post-COVID protocols. However, there are a couple of concerns, including home health aides’ unregulated personal hygiene and lack of PPE and rapid construction and introduction of digital tools/portals that are challenging for patients to master and are rarely interoperable with other systems.

Despite excitement about virtual and remote visit solutions, patients are increasingly eager to get back on-site and into their “normal” routines. Patients have been pleased with early innovations at sites that are still hosting patients in person, such as:

• Insisting patients wait in their cars rather than in waiting rooms;
• Providing escorts into the hospital or clinic;
• Limiting or prohibiting persons accompanying patients at their visits; and
• Extending visit hours and treatment windows to facilitate distancing.

The power of touch is not to be underestimated, nor is the importance of predictability and consistency. For many patients, regular therapy is a source of comfort, and relationships with physicians and research teams are deeply meaningful. Patients hope that technological innovation in our industry will not come at the expense of the personal bonds and emotional comforts of human interaction. From a practical standpoint, a physician will need to listen to a patient’s lungs or closely inspect an allergic reaction. Telehealth doesn’t work for everyone or every malady.

Sponsors can address patients’ concerns by continuously seeking patient feedback to identify anxieties that can be mitigated through knowledge sharing or planning, never assuming any single solution is “one-size-fits-all,” and recognizing that telemedicine inevitably introduces mental health concerns by limiting human interaction.

Flexibility and choice will be critical in patient-centric trial design. Do as much as you can to build flexibility into new processes, and identify channels that will enable you to communicate directly with patients about study impacts, process changes, modified timelines, etc. Examples include sending communications to sites for distribution to patients or leveraging the ClinicalTrials.gov help line.

Enabling Patient-centric Protocol Design

The following are steps sponsors can take to build a patient-centric program:

• Don’t use cost as an excuse. In fact, incorporating patient feedback into the early stages of study design will increase recruiting efficiency and decrease the chances of needing to accommodate costly late-stage amendments.
• Don’t use time as an excuse. Build patient-centricity into your protocol design as early in the process as possible, and continuously conduct collect patient feedback in parallel with other study activities. Talking to patients doesn’t have to be done in a vacuum.
  • Incorporating patient perspectives early allows sponsors to focus on endpoints that are important to the patient and scientifically meaningful — achieving the right balance will make your protocol more appealing to patients.
• Understand the business case for patient-centricity. Effective recruiting and retention plus reduced later-stage amendments equals increased savings and reduced spending.
• Accept the fact that regulators have made significant progress incorporating patient-centricity into policies and guidance. Regulatory bodies now expect patient-centricity by design.
• Adopt a new standard: directly tie study milestones to patient feedback checkpoints, and do not allow studies to progress until patient perspectives have been adequately addressed. The sooner we all adopt patient-centricity, the sooner it will become a universal expectation.
• Recognize how easy it is to connect with patients and how willing they are to talk. Even rare disease patients are relatively easy to track down through advocacy groups. Patient communities are tight and well-networked, which means that getting in contact with a single patient can often open the door to an entire swath of that population. 
• When building out your target product profile (TPP), trust that if you can bring value to patients, economic value will follow.
  • In fact, some forward-looking companies are now transitioning from the traditional TPP to a TPVP (target patient value product profile), which emphasizes the value to the patient and how to show that value starting at the inception of product development planning. Some unique changes can include:  
    • Patient population (including how to identify them)
    • Trial design
    • Value proposition (possibly including a likely standard-of-care (SOC) price comparison)
• Recognize that we’re no longer living in a “doctor knows best” society — information is widely available, and patients do their research to make informed choices about their care. Sponsors should commit to doing that work on behalf of patients and to making their trials the easy choice when compared against other modes of treatment.

Conclusion

If there’s one good thing that comes out of this pandemic’s devastation, it’s a renewed energy toward putting patient perspectives back at the forefront of our work. As one panelist pointed out, it’s important to remember that “we’re all patients at one time or another.” We must find a way to let that empathy drive our work toward setting a new standard of patient-centricity.

If you would like to be included in future Halloran Virtual Town Halls on COVID-19, please send an email request to halloranhelps@hallorancg.com.

Previous Articles In This Series:

• “Developing A Clinical Trials Strategy For A Post-COVID World”
• “Clinical Trials At Home — Implementing Telemedicine & Virtual Visits During COVID-19”
• “What To Expect From The FDA During (And After) COVID-19”
• “Adjusting To Clinical Trial Remote Monitoring During COVID-19: Working Smarter & Safer”
• “Clinical Study Risk Management During The COVID-19 Pandemic”
• “Clinical Study Conduct During The COVID-19 Pandemic — Challenges & Solutions”
• “Assessing The Impact Of COVID-19 On Regulatory Interactions, Inspections, & Audits”
• “8 Significant Risks COVID-19 Poses To Clinical Trials — And How To Mitigate Them”

About The Authors:

Todd Johnson, principal consultant at Halloran Consulting Group, has more than 20 years of experience in pharmaceutical development and clinical systems — from beginning his career as a clinical site monitor to developing operational performance dashboards and KPI/data reporting strategies. Having successfully managed clinical programs and assets, Johnson is knowledgeable in ICH/GCP, has clinical operations experience across multiple therapeutic areas, and has assisted in several successful IND and NDA submissions. Before joining Halloran, he led the Clinical Information and Informatics groups at Astellas and PPD, with an emphasis on operational performance metric/KPI assessment, data quality, benchmarking, dashboard development and reporting.

Hannah Yee, MPH, a consultant at Halloran Consulting Group, is experienced in clinical research, product management, and product design in health technology. Her focuses are in organizational change, process improvement and design, root cause analysis, human-centered design, and user/patient experience. She has recently worked with early- and commercial-stage companies on systems implementations, organizational redesign, and change management in both the pharma and medical device industries. Prior to joining Halloran, Yee worked as a human factors engineering consultant at Emergo by UL, where she supported usability evaluations of medical devices for regulatory compliance and design.