Democratizing Access to Clinical Trials through Remote Patient Monitoring

September 14, 2022 - Digital monitoring techniques quickly embraced during the COVID-19 pandemic are changing the relationship between clinical trials and patients, paving the way to increased enrollment, greater patient diversity, and cheaper trial costs.

“One of the biggest challenges in clinical trials is enrollment. It’s often why trials are delayed, and some trials end prematurely because the clinics can’t get enough patients to participate. It’s not because patients don’t want to participate but because traditional clinical trials make it difficult to participate,” explained Komathi Stem, Chief Operating Officer at Glooko, who has experienced the harsh reality of the present challenges in traditional clinical trials firsthand.

After members of her family were diagnosed with cancer, they longed to be included in cancer trials. However, common logistical issues that often plague others seeking participation also affected Stem’s family, such as getting patient records to the site, not meeting clinical trial requirements, difficulty locating trials, traveling long distances, and sacrificing time away from your loved ones to participate.

Access to clinical trials is a crucial issue for Stem, who believes those fighting for their lives should never have to choose between spending their final moments with their loved ones or at an on-site clinical trial.

“Accessibility is actually one of the best advantages of a digital trial,” she said. “People often forget that accessibility is a huge problem in brick-and-mortar clinics.”

When digital technologies are introduced, clinical trial access for patients drastically increases, leading to better enrollment numbers, larger data sets, and greater patient diversity.

How Democratizing Access Benefits Trial Participants and Staff

According to Stem, digital technology and remote patient monitoring are transformative tools for all stakeholders involved in a clinical trial, opening the door to a slew of advantages, such as making it easier for patients to participate and for staff members to oversee the trial participants.

“These remote patients can do a lot of things from the comfort of their home versus having to schlep into a clinic, find parking, and take time off from work,” noted Stem.

With the rise of telehealth fueled by the COVID pandemic, “patients have learned to engage and develop relationships with healthcare professionals in a virtual environment,” said Stem. “Sometimes, the patient’s family can be part of the visit and give their observations. Essentially, there’s much more information to gain from a virtual visit.”

Hybridized trials can support the needs of patients and staff in ways that traditional clinical trials cannot, but it is important that technology is deployed in the correct ways to build upon the necessary trust and relationship between the patient and clinicians.

Digital services particularly benefit older individuals, who have more trouble securing transportation to clinics. Virtual care “is sometimes the only way these people have to engage and interact if they crave that in-person interaction,” she added.

Stem notes that digital technology and remote patient monitoring also benefit clinical staff in relieving typical pain points such as enrollment and patient adherence, which contributes to added stress.

Additionally, remote patient monitoring can help maintain regimen adherence with frequent contact via text reminders and phone calls, which are often automated in a digital clinical trial. Digital automation in a clinical trial reduces the logistical burden on the staff while benefiting trial participants, explained Stem.

“In cases where participants are required to perform a task with their device, the study team can send digital reminders to improve adherence and reduce incomplete or missing data.”

While some may express concern over the logistics needed to digitize clinical trials, patients are becoming increasingly connected to the world of digital health, with roughly 85% of the American population owning a smartphone.

“Even in lower income classes, smart devices are their tie to the rest of the world. People almost have to have a smartphone these days but most people don’t live near clinical trial sites or can take time off from work.”

Even in cases where participants do not own smart devices, smartphones can be provisioned, which ultimately increases accessibility and community inclusion, Stem clarified.

Ensuring Consistency and Accuracy in Digital Trials

In a clinical trial, “remote patient monitoring addresses data incompletion and improves the quality of the data,” said Stem.

Although issues still exist with digital clinical trials, numerous tools can reduce accidental human errors. “The beauty of a digital solution is it reduces human error because the researchers can include threshold parameters,” added Stem.

For example, if a participant inputs a data point beyond that threshold, an alert can confirm or correct the error.

“When using real-world data as evidence in trials, some of the biggest concerns are incomplete or missing data. Remote patient monitoring devices solve that problem because a majority of the data is passively collected,” said Stem.

Passive data collection is the key to lowering trial costs and improving efficiencies. Additionally, this transformative digital approach minimizes risk to patients participating in trials because of the added 24/7 oversight, reduces the study timelines with faster patient enrollment, and provides quicker and more reliable data analysis.

Remote monitoring provides “a much more holistic view of what’s happening in the patient’s life and their experience in the trial, not just when they come into the clinic. For example, in hypertension, there is a well-known white coat syndrome that affects readings.”

White coat syndrome is fairly common and occurs when a patient’s blood pressure raises due to the added stress of being in a clinical environment, resulting in abnormally high blood pressure readings. Remote patient monitoring may be the key to effectively mitigating this medical phenomenon.

“The regulators are ahead of the industry and are encouraging the industry to introduce and integrate more digital aspects into their submissions,” Stem noted. In time, this effort should increase the use of digital solutions in the industry.

Finding a Partner    

With the recent interest and popularity, there’s been an influx of digital health companies expanding and marketing their capabilities for decentralized and hybrid trials.      

Stem advised trial sponsors looking to digitize their clinical trial design to look for a partner rather than a vendor and one with regulatory rigor and a global footprint.

Additionally, securing a trusted partner with therapeutic experience allows the study team to concentrate on the scientific aspects of the trial and not the logistical elements. According to Stem, a trusted partner “will help with trial design, give advice, and have deep experience in remote data collection and device management.”

Although clinical trials are the medical industry’s best tool for validating new drugs, therapies, and products, they are time-consuming, expensive, and risky. As the industry embraces the powers of telehealth technologies, digital integration could be the answer to conducting safe and effective research at a lower cost.

“Fundamentally, digital integration reduces the cost of clinical trials, which is the biggest line item in drug development, and, ultimately, gets new treatments out to patients faster,” Stem concluded.

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About Glooko

Glooko improves health outcomes of people with chronic conditions through its personalized, intelligent, connected care platform. Our proven technologies make lives better by revolutionizing the connection between patients and providers, driving patient engagement and adherence via digital therapeutics, and accelerating the speed of clinical trials.