COVID-19 and subsequent lockdowns across the globe have left biotechnology and pharmaceutical companies struggling to rescue clinical trials already in process, and keep upcoming trials viable in a starkly different landscape.
The coronavirus pandemic has impacted all parties in clinical trials. Patients are either unable to attend follow-up and treatment appointments, or they are fearful of leaving their house—especially to go to any medical facility. Labs, hospitals, and outpatient centers have closed to all but the most ill and are slowly reopening. Companies have had to either lay-off employees or find ways to shift to work from home options. And investors are both shaken by the markets and eager to identify any pharmaceuticals that might change the face of treatment for hundreds of thousands of newly diagnosed patients.
KPI sat down (virtually) recently with Sandra Shpilberg. Sandra founded Seeker Health and is the author of the book New Startup Mindset (already receiving well-deserved high praise). Seeker Health was created as an end to end solution for enrolling people in clinical trials; leveraging multiple social media platforms to inform patients, engage with them, and prepare them for participation in clinical trials. Sandra sold Seeker Health to Eversana in 2018, and her expertise in building a patient recruitment platform, and creating, growing, and selling a business is extensive and invaluable. She’s now started a new company, Adnexi, using technology for discovery and management of patient advocacy and KOL relationships.
Ms. Shpilberg’s advice to biotech executives in light of the coronavirus pandemic is to redesign the way clinical trials, the enrollment experience, the retention experience, and the commercial experience are presented and handled. “You have to begin to adopt these technologies that are already there. Virtual trials already exist. Virtual retention is there. All these things are there, but people were dragging their feet to adopt them because the in-person model was working. But the in-person model is no longer working.”
Clinical Trials Have a Long History of Challenges
Even before COVID-19, clinical trials were facing substantial challenges in recruitment, retention, and completion. According to David Shaywitz, estimates of the number of eligible patients participating in clinical trials may be as low as 2%. Patient recruitment was listed as the biggest challenge for professionals in Katie Rutter’s summary for Informa Connect, a European-based organization.
The cost of this low enrollment is staggering. Atlant Clinical reported that “80% of clinical trials fail to meet enrollment timelines and up to 50% of research trial sites enroll one or no patients… 72% of studies run more than one month behind schedule, with sponsors standing to lose $660,000 – $8 million for each day that the trial delays a product’s development and launch.
Low enrollment can begin to be addressed by creative problem-solving. As Sandra Shpilberg shared with us, leverage social media to discover who are the patient advocacy groups for a disease/condition. These groups are now some of the first places people go with a new diagnosis. Companies can also use online resources to find out who are the authors writing journal articles about specific topics. Tools such as Adnexi, can be leveraged to discover PAG and KOLs. Removing the dependency of in-person interactions will reduce and even eliminate some costs while increasing accessibility.
Let’s look at some options for clinical trials, both in the middle of a pandemic, and going forward, that will enable the same research, patient care, and science to continue using remote-focused tools and strategies. (Note: For specific recommendations and access to government guidance you may benefit from this presentation prepared by the Critical Path Institute’s PRO and ePRO consortia.)
The ability to provide more accurate and efficient patient monitoring has long been an ideal for the healthcare industry. James Caffrey, Leader of Strategic Projects & Ventures, Monitoring & Analytics for Philips identified remote enablement as essential to patient monitoring progress in an article for HIT Consultant in June 2019: “Remote enablement is the practice of remotely accessing… a patient monitoring system, to enable faster diagnosis and ensure optimal performance and productivity… [more efficient software updates allow] a crucial element to ensuring their cybersecurity needs are met.”
Better cybersecurity and remote updates mean that monitoring no longer requires manual, in-person fixes while providing better safeguards against cyber threats. Philips announced on May 26, 2020, that they’ve received FDA and CE mark clearance for a wearable device that allows for remote monitoring of hospitalized COVID-19 patients; a breakthrough that could substantially improve patient care and outcomes while reducing exposure risk to healthcare providers and decreasing the time needed to conduct patient evaluations.
In Caffrey’s article, much of the focus was on the security of devices that allowed for remote enablement, and the benefit of lowering the risk of cyberattacks, lower costs, and improving efficiencies. With COVID-19, remote enablement now has another selling point—decreased exposure between individuals. The advantages of this to clinical trials are substantial. Patients don’t need to take trips to sites for monitoring and providers receive real-time information about patient health without forcing contact between the two.
In January 2020, Scripps Research Translational Institute released the results of a study that used data available from one of the most popular wearables—Fitbit. They used information about user’s heart rates and sleep cycles to identify an emerging flu outbreak in real time. The study didn’t require any identifying data, and the information could be used to proactively deal with outbreaks weeks before they present in the healthcare setting.
Wearables aren’t a new thing. Clinical trials have used products like Holter monitors and continuous blood glucose monitors for decades. But these were/are used for a limited amount of time and only collected one data set.
Modern wearable devices can provide clinical studies with a substantial amount of data without impacting the patient’s daily routine in any way. Resting heart rate, minutes spent exercising, and sleep information are generally more reliable when provided by a wearable. Patients can record their vitals at any time using things like their Fitbit, Apple watch, or Poonyah all-in-one-device. When it comes to clinical trials, wearables decrease the patient’s self-reporting requirements and make them feel less like they’re being watched—leading to less changes in behavior, an ideal outcome.
Mobi health news reports that between 2000 and 2018, use of digital devices (including wearables) in registered clinical studies grew more than tenfold. One researcher wrote, “For patients, connected digital products can reduce the burden of trial participation and increase the inclusivity of clinical research by fostering remote monitoring and encouraging the enrollment of individuals who might otherwise be unable to participate due to socioeconomic circumstances or travel limitations.”
Artificial Intelligence (AI)
AI has long since passed the ability to perform typical human tasks, and is now used to complete tasks in everything from marketing to banking and space exploration that are beyond the abilities of human brains.
In healthcare, AI is used for robot-assisted surgery, dosage error reduction, cybersecurity, and stroke reduction. The use of AI in healthcare may achieve as much as $150 billion in savings for the US healthcare industry by 2026.
For clinical trials, AI and the AI subsets of Machine Learning and Deep Learning improve the entire cycle: cohort composition, patient recruitment, patient monitoring, and organizing data. AI finds meaningful patterns in large datasets that leads to better patient-trial matching and recruitment. So, from the very start of a trial, AI can ensure better outcomes.
Once patients are recruited, AI facilitates “monitoring patients automatically and continuously during the trial, thereby allowing improved adherence control and yielding more reliable and efficient endpoint assessment” ( Artificial Intelligence for Clinical Trial Design, Trends in Pharmacological Sciences).
COVID-19 is creating a new focus on the use of AI in healthcare. Mobi Health News reports that a UK-based company is working on a project that will use lung X-rays of COVID-19 patients to create a machine learning model to help healthcare providers in identifying the virus. This new drive towards AI and other technologies will lead to more opportunities for use in the clinical trial setting. Tammy Lovell writes, “There has been an emphasis on technology in healthcare and public health to fight the COVID-19 pandemic, including remote monitoring services, telemedicine, apps and diagnostic tools.”
There are apps available for patient recruitment and trial finding, patient monitoring, apps that take and send images, patient-reported outcomes apps, and apps that provide electronic data capture/clinical trial management systems. Shpilberg talks about the importance of connecting this ecosystem; applying analytics to improve the end-to-end process beginning with connecting referrals to what sites are doing. Companies conducting clinical trials become much more efficient when each step of the process ties into the next step.
If a clinical trial is already in progress and impaired by the coronavirus pandemic, an appropriate app may be the best solution for continuing patient monitoring and reporting. Most patients have a smartphone, and it could be as simple as licensing the right app, having the patient download and begin using it, and integrating the data into your records.
Using a patient’s phone during a trial is referred to as a BYOD (Bring Your Own Device) model. It does pose risks. Not all patients have access to reliable internet/cellular services to send and receive data. Your own network on the clinical side may be overloaded and provide challenges to receiving the data. Patients may struggle to learn how to use the app—especially if they don’t have access to someone knowledgeable who can help them. Privacy of data must be preserved.
According to the data collected by the Critical Path Institute, switching to a new mode of administration (like the use of an app) will require approval from the clinical trial license holder if you have one. But it doesn’t always require reporting the change to the Institutional Review Board (IRB). If the change is done to protect patients from an “apparent immediate hazard”, or if the IRB approval didn’t include methods for patient monitoring, you may not need to report it. When in doubt, contact them to be sure.
With more and more patients opting out of preventative care visits, or conducting sometimes less personal telemedicine visits, there is less opportunity for recommending clinical trials to patients during visits. Social media can play a critical role in bridging the gap. Social media provides an immense amount of data that can be used to connect with patients in ways that have never been possible in the past.
PcW Health Research Institute’s social media consumer survey found that 42% of consumers have looked to social media for health-related consumer reviews, almost a third have supported a health cause, 20% have joined a health forum or community, and a quarter of those surveyed had posted on a social media platform about a health experience. For companies facing any part of the clinical trial journey, social media is an avenue for learning about patients, identifying people and groups that are facing specific healthcare needs (including drug and trial insights they are discussing), connecting with those people, and providing messaging that relates to very carefully identified consumers.
Good News for Future Clinical Trial Success
Clearly, one of the biggest challenges for clinical trials has been location. As David Shaywitz wrote for the Timmerman Report in March 2020, “many potential subjects never have the opportunity to participate because they are not located near a trial site and/or the time and travel commitments are prohibitive.” Solving this challenge immediately makes participating in clinical trials accessible to many more patients.
In a March 2018 press release, Novartis announced a partnership with Science 37, committing to launch up to ten trials with a focus on moving to a “site-less” model. Evan Beckman, their Head of Translational Medicine encapsulated the best that remote clinical trials offer for patients: “Remote participation in research has the benefit of improving the breadth of participation from wider community and socio-economic backgrounds, while also allowing us to gather more meaningful real-world evidence in our clinical trials.”
But the good news comes with a caveat. Lionbridge Life Sciences writes, “Even where remote administration is feasible, the foremost consideration should be whether the patient’s setting/home environment and their other circumstances are adequate to protect their safety and privacy.” We talk so much about how technology can rescue current clinical trials and aid in future trials that we can forget the most important component of every trial—the patients.
When it comes to patients, Sandra Shpilberg has some sage advice: “When you have a patient that’s engaged and educated, they’ll go through anything to try and accomplish what they want to accomplish—which might be to go on this drug. What needs to be looked at right now is how best to engage and educate patients about new drugs, about the need for these new drugs, about whether or not they’re the right candidate for it… A lot of patients are opting out of appointments right now because they don’t want to expose themselves to the coronavirus… We need to focus more on directly educating patients because they are the ones who can drive their care.”
There will be new challenges that present themselves as clinical trials shift to a new, remote model. Fortunately, the will and funding to find solutions to these challenges is very present, and we can expect many opportunities to become available.