Clinical research professionals broadly agree that the COVID-19 pandemic has greatly impacted the clinical trial field, possibly changing the industry for good. While sites and sponsors are keenly interested in continuing their work, they must balance concerns about preserving patient and staff safety with the need to collect vital research data.
Stewart Whiting (SW), cofounder and chief technical officer of Current Health, spoke with Outsourcing-Pharma (OSP) about how the pandemic has transformed the clinical trial field, and how advanced technology like remote patient monitoring (RPM) could help sites and sponsors overcome some of these formidable obstacles.
OSP: Could you please share your perspective on how the COVID-19 pandemic has impacted the clinical research industry?
SW: COVID-19 highlighted the need for a more efficient path to viable treatment options. It can take 10+ years for a new treatment to complete the journey from initial discovery to the marketplace.
COVID-19 therapy and vaccine trials have forced us to rethink the scale and speed of clinical trials. In a world where site travel and face-to-face patient engagement is extremely difficult, remote-first virtual trials have proven themselves to be new, efficient and effective ways of working.
Furthermore, the pandemic has forced the pharma industry to consider how they can limit virus exposure during the clinical trial process, such as when a patient must visit the hospital for regular check-ins. At the very beginning of the pandemic, this caused many trials to slow or grind to a halt given the lockdown and high-risk nature of patients who are often enrolled in clinical trials.
Going forward, the industry has recognized that virus threats aren’t going to stop after COVID-19. There’s a renewed emphasis in building out infrastructure for rapidly understanding and mitigating against future threats.
OSP: Could you talk about some of the solutions sites and sponsors have been coming up with to help mitigate these obstacles? Which have been better/more effective than others?
SW: In response, we’ve seen many sites go to virtual-first or fully distributed clinical trials. In this new world, the majority of preparation as well as patient interaction happens remotely. For clinical trials, the typical challenges that come along with remote work are amplified by the number of moving pieces and coordination that needs to happen.
For example, a typical clinical trial involves multiple physical sites where administrators would be trained on-site on how to enroll and manage patients. Transitioning this process to fully remote requires new materials, training platforms and a lot more coordination.
What’s important to remember is that for clinical trials, there is the added complexity of data security and patient health information (PHI). Any process needs to balance simplicity with security.
At Current Health, while we had online training tools, our preferred training method was to visit sites in-person. With COVID-19, we’ve had to invest heavily in our online training materials. The benefit here is that site teams get to familiarize themselves with the platform on their own time.
What’s more, when they have a question in the moment, we’ve built out our support team to quickly respond to situations. We’ve built secure tools that enable help to be just a click away, and the site teams love it.
OSP: Could you please share some of the less-than-desirable consequences if sites and sponsors fail to effectively handle these challenges?
SW: As many of us are experiencing, there is a learning curve with going remote and confusion can be inevitable. From a project management perspective, there are a lot of workstreams to manage across multiple teams.
Doing this virtually for the first time can be difficult and cause virtual trials to go slower than desired. What’s more, simple things like patient coordination carry the increased risk of data security issues.
OSP: Let’s talk about one specific solution: what is remote patient monitoring?
SW: Remote patient monitoring (RPM) helps health systems, payers and pharmaceutical companies implement innovative home-based care models that accelerate patient discharge, avoid hospitalization events and improve health outcomes. RPM platforms enable the transition of healthcare delivery from the hospital to the home by providing the broadest picture of patient health at home using continuous monitoring and patient-reported symptoms.
Using machine learning, RPM platforms can identify patients at risk of disease exacerbation and alert the providers who can deliver earlier treatment within the home using built-in patient engagement tools. RPM allows providers, payers and pharmaceutical companies to reduce the cost of care while improving patient health and providing proactive treatment far earlier.
For example, Current Health’s platform continuously and passively monitors patient vital signs, such as oxygen saturation, pulse, respiration rate, skin temperature and activity levels, to capture ICU-level insights on patient health outside the four walls of the hospital. The platform also integrates wirelessly with a range of best-in-class peripheral devices, to capture vitals such as blood pressure, weight, spirometry, axillary temperature and, most recently, glucose.
By leveraging data analytics set at the individual or population-level, the platform can identify early deterioration based on changes in combined vital signs and symptoms, allowing for better, more proactive care.
OSP: What kinds of adjustments does RPM require a clinical trial team to make?
SW: First, it’s important to acknowledge that the process of selecting a RPM platform will be a new experience for clinical trial teams. When evaluating various wearable devices, they’ll have to make important decision around which vital signs they want to track during the trial and the frequency of data capture they need to meet their specific trial end points.
During patient enrollment, a clinical trial team must explain the data collection process, how the data will be used, and get patient buy-in to use the monitoring device as needed. During training, patients must fully understand how to use the wearable device, but also the value of patient adherence and continued use throughout the trial.
Additionally, with RPM, clinical trial teams have access to more patient data than ever before. This means they need to invest in data management tools in order to fully understand the data being collected and identify trends.
OSP: Could you please talk about the benefits RPM can help a trial team obtain?
SW: By collecting critical biomarker data at scale, RPM can paint a holistic picture of how the treatment impacts a broad population. This can improve the clinical trial team’s understanding of adverse events, how they present across specific demographics and populations, help determine the viability of the drug and enable pharma companies to bring viable treatment solutions to market faster.
This data can also improve the safety and effectiveness of the trial: By continuously and passively monitoring participant’s vital signs, the trial team can be alerted to any issues throughout the trial and can move quickly to address them, ensuring that the participants’ safety is never at risk.
OSP: Could you share examples of how RPM is currently being put into play?
SW: Current Health is working with health systems and pharmaceutical companies to support COVID-19 monitoring. These organizations are using Current Health’s RPM platform and wearable device to continuously monitor vital sign data, such as oxygen saturation levels as well as body temperature, heart rhythm, respiratory rate and activity levels for patients participating in the studies.
This continuous monitoring ensures the safety of participants as well as provides insight into biometric profiles associated with COVID-19 disease progression. By collecting this large amount of patient information, healthcare companies can accelerate the path to treatment and bring vaccines to market as quickly and safely as possible.
Additionally, we are working with pharma companies who are thinking about how RPM can be used to extend treatment delivery into the home. In particular, we’re seeing considerable growth in clinical trials that are looking to change drug labelling to allow in-home, rather than in-hospital, drug administration. This is particularly true for oncology therapies where adverse reactions can be serious but easily treated if caught early. This shift to at-home therapy is largely driven by patient desire to minimize risk of exposure to COVID-19, which is now supported by technology such as telemedicine and remote patient monitoring that has become widely adopted due to the pandemic.
OSP: How is RPM helping with COVID-19-specific research?
SW: Current Health is currently collaborating with Mayo Clinic to accelerate the identification of COVID-19-positive patients and predict symptom and disease severity in patients, healthcare workers and other at-risk individuals in critical service sectors. Using digital biomarkers collected by Current Health’s FDA-cleared remote monitoring sensors and platform, experts from Mayo Clinic and Current Health are able to expedite identification and assessment of treatment efficacy and improve care for patients with or at risk of COVID-19 infection; through this collaboration, Current Health and Mayo Clinic aim to improve patient outcomes while preserving and optimizing health system capacity worldwide.
OSP: How different do you think the clinical trial landscape post-pandemic will look like, compared to what it was in the months before the virus landed on us?
SW: Clinical trials have been leveraging tools like RPM during the pandemic so they can collect data at scale to accelerate the path to effective treatment and speed up the commercialization of treatments. This trend does not seem to be dissipating, so it is likely to become permanent in the healthcare and clinical trial landscape.
