Inspiration abounds at Fierce Biotech’s Virtual Clinical Trials online conference
Virtual clinical trials (VCTs) have been on the life science industry’s radar for many years with the expansion of digital technologies, increased focus on patient centricity, and the need to ensure patient adherence and persistence to support evidence generation in a rapidly advancing digital age. Fierce Biotech’s online conference started with a strong challenge to commit to the change and embrace decentralized clinical trials (DCTs) through virtual means. Craig Lipset, Founder of Clinical Innovation Partners LLC, challenged sponsors in attendance with the following: “We were able to change to accommodate a virus. How can we sustain that change to accommodate the patients who are participating in our studies?”
The conference on April 22nd and 23rd utilized a virtual platform to deliver engaging topics with interactive question and answer sessions on subjects including understanding COVID-19 impacts and what we are learning about optimal Clinical Trial conduct, how it applies now and in the future, what the industry has supported to date for VCTs, and how the first fully virtual clinical trial is being launched during the COVID-19 pandemic. The conference also explored how we might apply legal concepts and solutions with emerging technologies. Specifically, around transparently collaborating with patients, caregivers, investigators, sites, and regulators to leverage virtual clinical trial approaches during trial and protocol design and how to maintain data consistency when transitioning from traditional to virtual trial execution. Here are some of the key takeaways from my experience.
1. Virtual Clinical Trials are ready to be adopted now and we should be accelerating it.
Dr. Sy Pretorius, MD, Vice President and Chief Medical & Scientific Officer of PAREXEL, spoke to attendees about what drives the need for decentralized (virtual) clinical trials and how PAREXEL sees them progressing. A continuum of virtual clinical trials from traditional patient focused trials through to fully virtual trials exists, with most trials being hybrid approaches. Predictions have been made that as many as 50% of studies could be partially (or hybrid) virtual within 5 years and Dr. Sy Pretorius advised that rapid uptakes in telemedicine and virtual approaches are likely to have a large influence in accelerating that timeline.
It was highlighted that the foundational services and support technologies exist and are widely available to support VCTs including home support options like home nursing, direct to patient shipments, and mobile phlebotomy. With the increased adoption of telehealth, sensors, and direct-data-entry platforms many patients can engage and even determine where they’d like to see at home engagement versus at their physician’s office. It is not without its challenges including those on the disadvantaged side of a virtual environment and there being no centralized and adopted platforms to standardize patient and healthcare provider engagement. Selecting which approaches and technologies to use and when to use them was still widely debated, however attendees and speakers seemed to agree that greater regulatory tolerance for innovative and non-traditional approaches were emerging and sites, patients, and caregivers will now have increased awareness to virtual clinical trial options with the COVID-19 experience. It’s expected that their demand for this type of service will continue.
2. Adopting this change means supporting all stakeholders including sites, patients, caregivers, and internal life science functions to innovate together at trial design.
During the Leveraging Technology to Drive Direct-to-Patient Trial Designs session, Peter Schaeffer shared that as we are now on an accelerated path, we cannot work in terms of years or even months to realize these visions. He shared the efforts he and others have focused on as part of TransCelerate’s Patient Technology (PT tools workstream) looking at technologies and the patient experience holistically to improve patient experience and accelerate clinical trials. A thoughtful question during this session highlighted that Principle Investigators and patient participants are not the only ones who need their burden lessened. When discussing the Alzheimer’s space, there are 50 or 60-year-old caregivers supporting their 70 or 80-year-old parents in these clinical trials. There are many more caregivers than we had in the past and we must think of them separately from the patient and better leverage them when we think of engagement and resilience. Ed Cox, the digital therapeutics thought leader who hosted day 2, challenged us to consider, “If we are able to think of solutions that can fundamentally change the biology of a human we can certainly take the extra time to roll out solutions that are compassionate and fit into a caregivers already very challenging life”.
But truth be told, what stood out most to me was that this is about integrating the patient perspective and how they and their care teams want to be engaged. This starts with ensuring that the studies are designed to deliver on end points that are truly meaningful to patients, caregivers, and healthcare providers. Further, this would demonstrate to them that the study and the drug are a clinical success in addition to meeting regulatory expectations. While it was recognized that end points for today’s research would have needed to have been changed 18 to 24 months ago, we have the opportunity to improve future designs. Digital Medicine Society’s (DiMe) crowdsourced Library of Digital Endpoints was highlighted several times to aid with the transformation due to its focus on industry-sponsored studies of new medical products or new applications of existing medical products.
3. Shifting to virtual clinical trials allows us to marry the R&D program practices with true clinical practices to represent real world use, while operating with a focus on the regulatory end points and the statistical rigor required by clinical trials
Dr. Alka Shaunik, Jennifer Goldsack, and Mohammed Al encouraged attendees to collaborate across their organizations and partners to think holistically about the full R&D program through Phase IV studies during the Multi-Stakeholder Perspective on Virtual Clinical Trials session. A highlight of the session was rethinking what “hard to reach populations” really means. It’s important to not constrict them to rare diseases or a few patients with a rare surgical outcome but instead thinking about what makes it hard to engage and retain patients with diseases like diabetes and hypertension which have millions of patients across the world.
Dr. Alka Shaunik really delivered on the heart of the opportunity when she shared that Life Science companies, ”would like to get the patient fully integrated into clinical trial design giving us true outcomes of our products, of our drug development and the clinical experience as that is what determines what happens in the real world”. Although the clinical practice can be different than the R&D program, trial and protocol designs must account for how we bring them closer together to truly capture what a patient’s use of the drug is and their experience while using it. Additionally, a focus on delivering the regulatory approval end points and statistical rigor that is needed.
Ideas to innovate included exploring the use of local providers leveraging telemedicine and electronic health records as evidence during clinical trial conduct to help address how the clinical practice can be different than the program, and use it to help bring these together and engage PCPs. Remembering that trials don’t require brick and mortar sites, but they do principal investigators, so ensuring this transformation doesn’t become burdensome as we both welcome and educate them during an accelerated launch of a new clinical trial model to enhance patient diversity and improve engagement for patients and caregivers.
Multiple sessions talked about what it takes to be successful with virtual clinical trial approaches, highlighting that our priorities must focus on:
· Maintaining patient safety
· Selecting the right models for the right studies to utilize hybrid and fully virtual approaches
· Protecting patient privacy while respecting their need for appropriate transparency and data return
· Ensuring data quality during transition but also when data may not be available as expected
These priorities are ultimately to reduce the burden on patients, caregivers, and sites while we can reduce practical, financial, and geographic barriers to participation in order to positively impact recruitment, retention, and trial cost.
Ultimately the message was clear across the conference — we have the catalyst to advance this transformation leveraging virtual clinical trials and we can make this improvement long lasting. The success of virtual clinical trials lies with the Life Sciences industry to collaborate with regulators, health care professionals, patients, caregivers, technology providers, and other sponsors to marry digital patient and caregiver engagement tools, telemedicine, and human centered trial and program design in a way that reduces the burden of clinical trial participation.
Want to know more about virtual clinical trials. The second Virtual Clinical Trial Conference will take place October 6th & 7th, 2020. For more information and access to session recordings visit the event registration page.
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