If COVID-19 has taught the industry anything, it is that we must think differently to elevate innovation around clinical development, especially for the most vulnerable populations. For patients with cancer, their families, and health systems, the burden of cancer, physically, emotionally, and financially, is mounting. Add in a global pandemic the concern only grows.

But, exactly how do patients receive much needed continued care when there is limited and, in some cases, no access to providers, trial sites, and more? And, with the risk of exposure to COVID-19, will immunocompromised patients be safe to participate in trials in the traditional sense now and in the future? How does drug discovery continue safely?

COVID-19: From interest to action

We’ve learned that through the global pandemic, 64% of specialists reported a dip in the initiation of cancer treatment by patients and a 44% decline in patients seen per week.* If not addressed, it is an extraordinary strain, impacting hundreds of thousands of patients worldwide.

The pandemic is making the oncology community notice how patient-centric virtual trial solutions are helping to accelerate trial timelines, reduce cost, enhance data quality, and most importantly, ease the burden on patients. Among the oncology community, remote tools and strategies were highly ranked for trial assessments. And, it doesn’t hurt that sponsors are receiving encouragement from regulators to consider virtual elements, as needed, to maintain trials.

COVID-19 is transforming interest into practical action for patients in need.

A practical shift to virtual elements: The hybrid model

Simply put, there are several key benefits to virtual and hybrid trial elements:

• Increasing patient recruitment, including diverse patient populations, and engagement
• Streamlining operational processes and automated workflows to reduce site burden
• Continuous remote monitoring and ongoing risk management, while making changes quickly
• Improving data quality

Despite regulatory support and favorable perspectives on virtual trial solutions, sponsors may be hesitant to completely shift from traditional processes to fully virtual models. It’s understandable, given the unique needs of oncology research.

In a hybrid model approach, trials are not completely decentralized but do weave in virtual elements. For oncology trials, this model may make the most sense.

Through this model, tech-enabled solutions allow patients to participate in the trial, including onboarding, televisits, and sharing data with study teams, from the comfort of their homes or wherever they may be. This is obviously a safeguard during a global pandemic but also on an ongoing basis as overburdened patients can participate, as their schedules and conditions allow. By collecting ongoing data remotely, investigators are able to continuously monitor for safety risks as well and make real-time adjustments.

Because the human factor has to play a role in executing virtual trials, site staff are properly trained to facilitate patient discussions and study visits virtually. To help keep patients engaged and compliant, sponsors may add a layer of support such as a study coordinator who can take the workload off patients by providing device training, arranging local lab visits, and more.

Trained healthcare professionals can conduct home health visits to ensure necessary testing and direct-to-patient deliveries of study drugs and supplies continue in the remote format. But, as patients may need to visit sites for more complex medical procedures, imaging, or on-site infusion administration, they can.

The key to shifting to virtual models is flexibility in incorporating components as they make sense for the sponsor, trial, and of course, the patients.

Virtual trial suitability

When assessing whether an individual trial can shift or begin in a virtual format, oncology researchers have unique factors to think through before making adjustments. For example, if an investigational drug has a known safety profile and trial endpoints can be met remotely, a virtual or hybrid approach could work. We help our customers look at each trial independently by performing risk assessment to determine if virtual elements are suitable for consideration. Depending on the treatment, subject group, endpoint needs, and study design, we identify exactly where virtual adjustments can be made.

In working through operational specifics for a hybrid or virtual model, there are a few critical pieces getting a trial with virtual elements up and running successfully.

• Keeping the patient voice in mind in trial design and engaging key stakeholders early to secure buy in and ensure best practices from the start.
• Assessing sites qualified for the transition from traditional to virtual trials.
• Setting up technology to collect protocol assessments and provide comprehensive site training.

With a push from a global pandemic, the oncology community is realizing that what once seemed “risky” can actually be a safe and viable option for elevating patient-centric oncology research. As no two trials are alike, we know that virtual approaches are not appropriate for every oncology trial. But there is a lot of room for actionable change. With early evaluation, there is value to patients and sponsors in considering integration of virtual approaches into oncology trial design and delivery.

Please contact me to discuss how we can help incorporate virtual approaches into your oncology trial.

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*IQVIA pulse survey of oncologists and hematologists (n=73) in the U.S. conducted April 3-15, 2020.