Clinical Trials At Home — Implementing Telemedicine & Virtual Visits During COVID-19

By Hannah Yee and John Ferraro, Halloran Consulting Group, Inc.

There is no denying that the COVID-19 pandemic has spurred tremendous innovation across our industry. Even more impressive is the pace at which we have been able to implement technology solutions that can facilitate continued progress in our critical activities and trials. Most importantly, the expansion of telemedicine and virtual solutions is enabling us to meet our patients’ needs while also maintaining patient safety, study integrity, and data quality.

During Halloran’s latest COVID-19 Virtual Town Hall, expert panelists discussed the telemedicine technology landscape before the COVID-19 outbreak, considerations around vetting and implementing these solutions during the pandemic, and the future of virtual visit technology as shaped by the current environment. In this Q&A article, we review some of the questions posed — and answers provided — during the Town Hall event.

What did the technology landscape look like in clinical trial conduct before COVID-19?

Fortunately, the technology now in demand has been in flight since the early 2000s. Home visit coordination, at-home procedures (infusions, blood draws, etc.), self-report solutions, video visits, and digital endpoints surfaced long ago. Until now, the barriers were chiefly regulatory obstacles around implementation and the business case necessary to drive change management internally.

Sponsor uptake of technology to enable virtual visits was historically incremental, and successful launch required a 7- to 8-month planning runway. And even where solutions were implemented, patient uptake was slow. According to an article published in Nature Digital Medicine, less than 0.4 percent of active trials in ClinicalTrials.gov used a tech solution such as telemedicine platforms, wearables, or smartphone data mining. Clearly there is an opportunity to expand the use of these technologies.

What is the argument for the use of telemedicine/virtual visit technology?

Home visits used to be cutting edge, but the current situation is forcing us to innovate further — many trial teams must either find a way to support virtual visit elements or resign to either canceling or putting the study on hold. The technology is widely available and, for the most part, familiar (i.e., video platforms, email, online shared spaces). Also, regulators have loosened restrictions on the use of virtual platforms, and patients want and expect options now.

Recent data shows that patients still want to participate in clinical trials during the pandemic — even under the current circumstances, more than half of surveyed patients indicated they would be willing to participate in a trial within the next month. Only 22% indicated discomfort participating amid the COVID-19 pandemic. The vast majority supported an increase in telehealth services and digital solutions.

In addition, the use of telemedicine helps conserve personal protective equipment (PPE) and safeguards the integrity of our healthcare system so it can serve those in acute need.

What should sponsors consider when planning the use of a telemedicine or virtual visit solution?

Any virtual or remote solution that sponsors develop should be patient-centered above all else. Sponsors must communicate with patients to understand how their needs are evolving.

In the context of a sponsor needs assessment, virtual visit technology solutions can be grouped into three levels, increasing in complexity:

• Level 1: Forms available for patients to complete at home to capture critical data, and a platform to house the data collected via the forms
• Level 2: Bringing phlebotomists and other medical professionals into the patient’s home to perform medical procedures that would traditionally be executed in the clinic
• Level 3: Migrating all clinic/hospital data to platforms amenable to at-home use

Consider this ABC metaphor for virtual visit planning:

• Airway – delivering the solution: How can you most effectively connect with the patient (e.g., through a phone/video platform)?
• Breathing – operationalizing the solution: How will you monitor your critical variables and collect meaningful data?
• Circulation – making the solution continue to work: How will you move this data to a useful and accessible location?

Take into account the complexity of the study’s clinical assessments, biometrics, functional studies, imaging, etc. when choosing a technology, or a combination of solutions, that will be most effective for the specifics of the study. Biopsies, imaging, and blood draws are some of the most challenging procedures to execute virtually.

Have a robust communication plan. Sponsors must remember that patients are also adjusting to the rapidly changing pandemic environment. Study teams transitioning to at-home or virtual visits should over-communicate with the patients to quell concerns around safety, equipment availability, logistics, personal hygiene, and other anxieties related to COVID-19 and the patient’s condition.

For home visits, consider a two-way opt-in policy, under which the visiting healthcare provider and the patient opt in or out of each home visit before it takes place. This empowers both parties to be the agent of their decision-making and have more control over their environment.

Speaking of decision-making, it is often a rate-limiting factor. Operationally, most tech solutions can be launched in 5 to 7 business days. The hold-up is typically organizational politics and clunky decision-making processes. We have now eliminated those organizational barriers and should acknowledge that the aspirations of the past are now a reality.

What should sponsors consider when selecting a telemedicine/virtual visit vendor or methodology?

Some suggested vendor selection criteria include:

• CFR Part-11 compliant
• Patient-friendly and easy to use
• Accessible via a patient’s personal device (BYOD – bring your own device), eliminating the need to purchase hardware
• E-consent compatible
• Low administrative burden for site staff — may be simpler than their normal procedures
• Compliant with HIPAA / regional regulations
• Central monitoring features included to enable remote source data verification (SDV)

What technology is in-flight currently?

The obvious ones are phone, email, and video solutions such as WhatsApp, Zoom, FaceTime, etc. However, there are also plenty of telemedicine platforms built specifically for clinical research that are more tightly controlled than publicly accessible chat and video apps. These solutions are HIPAA compliant and typically include a robust support structure.

How can we ensure that the innovation spurred by COVID-19 endures into the future?

Suggestions that came up during the Town Hall included:

• Prove to industry and regulators that we can take an idea and execute it efficiently and effectively. Take advantage of the fact that industry stakeholders and regulators are poised and motivated to move quickly and adapt generously.
• Execute flawless transitions that hold patient safety and data integrity measures intact, and ideally that outperform old conventions.
• Maintain a “parking lot list” of learnings to embed into our future organizations and enable effective scaling of these solutions. We must hold ourselves accountable to this list and truly adapt processes, vendor selection, protocol development, endpoint planning, etc. to reflect relevant changes.
• Collaborate across industry players. Without cooperation between sites, patients, providers, sponsors, regulators, and CROs, there will be no progress.
• Design patient-centered virtual capabilities into all future trials, from the start of study planning.

Conclusion

While COVID-19 is devastating to our industry in many ways, we can choose to answer the call-to-arms that this situation has presented. The opportunity for disruptive innovation is at our doorstep, and we have all the tools we need to build real change in the way we design and conduct clinical trials. We must work together to realize the potential that we have to create enduring solutions that will better meet the needs of the patients we serve.

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:

• “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:

Hannah Yee, MPH, a consultant at Halloran Consulting Group, has experience in clinical research, product management, and product design in health technology. Her focuses are on 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.

John Ferraro, principal consultant at Halloran Consulting Group, has more than 28 years of experience in clinical operations/research in the biotechnology and pharmaceutical industry. During this time, he has been successful in all sizes and types of organizations as well as in a myriad of therapeutic areas, most recently oncology, hematology, immuno-oncology, and rare disease. Ferraro excels at operational strategic planning, oversight, and delivery of clinical development programs. Prior to joining Halloran, he led his own consulting firm, where he was engaged with organization types, including a global CRO, a medical device startup, and a generic company as their VP of clinical operations or clinical advisor.