By Joseph Constance
Remote patient monitoring (RPM) and virtual, decentralized, clinical trials have gained momentum as the pharmaceutical industry harnesses these strategies to tackle COVID-19-induced clinical trial disruptions.
These strategies have been percolating in the background for some time. They would have appeared eventually, even without COVID-19. While we are part of an industry that likes to consider change pensively, the pandemic spurred their use as companies look to technology to keep the business of running clinical trials as close to schedule as possible.
And these strategies are here to stay, with the benefits and advantages they offer, playing an integral part in the move toward patient centricity. RPM is about more than technology. It’s part of a larger equation to make clinical trials more accessible to participants. RPM helps patients center around the clinical trial protocol. It provides subtle notifications and guidance along the patient journey. You might even harness RPM technologies to combine data from different sources to identify novel outcomes.
RPM utilizes digital technologies to collect medical and other health-related data from individuals in one location, such as their home or office, and electronically transmit that data securely to health care providers or clinical trial staff at a different location so that they can assess an individual’s current health condition and progress in a virtual clinical trial.
Remote monitoring has become pervasive among consumers. It is estimated that the global remote patient monitoring market could total $2.14 billion by 2027. The market is experiencing greater demand thanks in part to the growing use of the internet and the emergence of advanced technologies in the healthcare arena. Digital health itself has developed into a successful business, attracting several participating businesses from both within and outside of healthcare.
Assisting Clinical Trials
RPM can optimize the clinical trial experience in a number of ways, such as by:
- Enhancing study design.
- Streamlining the enrollment process.
- Growing patient centricity and engagement.
Faced with much paper documentation, clinical research associates have to manually verify data contained within many files for source data review and source data verification. In addition, to share information with monitors remotely, sites often shift to printing, sharing documents by email, or enabling direct access to electronic medical records (EMRs). But when done manually, these practices can introduce errors or create compliance issues with the Health Insurance Portability and Accountability Act (HIPAA). Email and paper methods of exchanging information add to data-sharing and collaboration complexity.
Remote monitoring systems can streamline the sharing of source information to authorized individuals, preventing unauthorized access to identifiable patient information and reducing tracking and filing errors.
To do the best possible job, RPM technologies — software, apps, instrumentation – have to meet the needs of patients and clinical trial sites by being user friendly, quick, readable, portable, secure, and compliant with the Institutional Review Board, HIPAA, and the like. RPM technologies should enable enrollment while the patient is at the trial site, and enable direct, paperless entry. Platforms should offer screening, consent, patient and provider surveys, and coordinator data entry.
Improvements for the Patient
RPM reduces the patient burden. Fewer site visits required. Those participants with mobility issues, travel concerns, and chronic and debilitating illnesses have a greater opportunity to participate in the trial.
Participant diversity can be improved through remote monitoring. Race, biological sex, age, disease, and location can be accounted for with the right processes. Screening and consent can be completed remotely, and a telemedicine app provided for patients to use at their homes. Moreover, remote monitoring and tech-based recruitment solutions avoid physicians’ bias when it comes to selecting patients for trials.
A search of Clinicaltrials.gov shows that more than 500 clinical trials have been completed or are underway which involve some aspect on remote monitoring, ranging from studies examining the Efficacy, Safety and Cost of Remote Monitoring of Patients With Cardiac Resynchronization Therapy, to studies involving Remote Monitoring and Social Support for Hypertension Management.
An Acceleration of Virtual Trials
“The growing use of real patient monitoring is largely due to the accelerating adoption of virtual trials and the need to monitor at a same or similar level as you would have had in a supervised medical setting,” explains Ivan Jarry, Chief Executive Officer at four-year-old ObvioHealth, a virtual research organization (VRO) involved in managing virtual clinical trials.
The company has launched a hybrid clinical trial for the treatment of COVID-19, using a study design with digital data capture to remotely monitor patient vitals. This Phase II/III study is examining the safety and efficacy of RedHill Biopharma’s RHB-107 (upamostat), using ObvioHealth’s clinical trial ecosystem, including five digital devices, a patient-centric smartphone application, and home healthcare visits.
The company says it developed and launched one of the first patient-centric apps downloadable on smartphones that enables people to participate in clinical trials from their homes. Since its launch, the company has undertaken 40 studies involving 22 blue chip clients, implemented in 28 countries, and in more than 16 different therapeutic areas.
Making the Patient the Center
“With real patient monitoring and virtual trials, the patient is more than just a patient,” says Jarry. “The patient actively participates in the study. For example, they may have to take their own blood pressure, instead of having a nurse do it. They need to make sure the measurement is done properly. They become more involved.”
RPM also helps the trial staff see, based on data from remote devices and apps, whether a patient is properly following protocol, performing tests properly, and self-medicating properly, according to the executives. “For us, it’s a way to have a continuous flow of data on adherence and compliance to the protocol,” notes Jarry.
But RPM still has some hurdles to overcome. While RPM improves clinical trial accessibility, those who reside in rural or underdeveloped areas are challenged because such locations are not wired, making it difficult to reach populations that need care. Moreover, there still is need to develop specialized technology that targets more specific diseases so that clinicians can obtain more in-depth data. Optimizing remote technology also will enhance the patient experience in clinical trials.
Another challenge involves training patients to use devices and apps properly. Training normally done at the study site might have to be done remotely by virtual study coordinators, according to Jarry and Craig Gravina, Chief Technology Officer at ObvioHealth.
There doesn’t appear to be any one device or app that is used more than another for RPM, indicates Gravina. “There is no one device that covers the full spectrum of measures that are needed for more advanced trials,” he notes. On the other hand, the company faces an ever-evolving technology market, according to Jarry.
“It’s a fast growing market, and we want to use the latest technology,” Jarry says. “But six months from now there’s going to be a new device that will combine multiple functions that’s easier for the patient than having several devices. We need to constantly evaluate new devices with the objective of creating the best experience for the patient and making it easier for us to get better data. These are triggers for our virtual study coordinators. They may see an improper reading or may not be getting a proper measurement, which is monitored in real time. This would alert them to intervene and reach out directly to patients to correct the situation, ensuring trial data is as accurate as possible,” Gravina added.
“We also are concerned about data security and privacy,” says Gravina. “We have to be sure that all data is transmitted securely. And we validate devices to make sure that they are adhering to appropriate protocols.”
Those devices that monitor vital signs, such as heart rate, respiratory rate, and temperature have to be validated by the FDA or CE-marked by the European Union. Devices used for research or observational measures, such as activity tracking, do not require validation. “A device doesn’t have to be validated if it is not measuring a primary endpoint. It’s permissible to use a non-validated device to measure secondary endpoints for analysis,” adds Jarry.
The Future: Combining Remote Data
Jarry and Gravina see the future of RPM as more than just taking individual measurements remotely. “A remote device could be more than just one source of data. It could be a source of informative audio and video imagery. We also can learn about your medical history, your recent visits to your doctor, or track continuous activity” Jarry explains. “That continuous flow of data is extremely rich and valuable. For example, we can take continuous temperature measurements every few seconds. Interpreting a continuous flow of data as simple as temperature is way richer than what could do before.
“What’s really interesting is when you combine data from different sources to identify novel outcomes. When you combine data like respiratory rate, oxygen level, and coughing frequency, you might possibly predict COVID-19 progression and recovery, for instance, which might allow you to intervene in a study at an early stage,” Jarry continues. “If it doesn’t look like you’re headed towards success, you might adjust dosage mid-study or identify issues that might be safety-adverse.” he states.
RPM in the Field
There are a number of RPM platforms and devices intended do the job with the patient in mind.
- Florence offers software that facilitates clinical research, including trial document management.
- Zanthion offers an RPM product that uses sensors on the patient and in the environment to collect medical and other forms of health data and electronically transmits that information.
- iHealth offers FDA-approved mobile health devices that measure and track a range of health vitals, including blood pressure monitors and glucometers.
- Bioinetllisense offers a Data-as-a-Service (DaaS) platform BioSticker, an FDA-approved device, which allows for up to 30 days of continuous vital signs monitoring. Designed for remote data capture, this single-use device can be discreetly worn on the upper left chest, and monitors respiratory rate, heart rate at rest, skin temperature, body position, activity levels, sleep status, and symptomatic events.
- Itranslation offers apps that are synchronized with health tracking tools, such as wearables, sensors, and medical devices for RPM.
- Medtronic offers the MyCareLink patient monitoring system for some Medtronic implantable cardiac devices.
- OneLife Technologies, a mobile medical software and data collection company, offers the AT&T LTE-M certified medical and health data wearable.
- Dexcom devices help diabetes patients, their caregivers, and healthcare providers monitor glucose levels.
- The Neoteryx Mitra devices are designed to simplify remote specimen and blood collection at home using volumetric absorptive microsampling (VAMS) technology.
- ChroniSense Medical is marketing the Polso multiparameter vital signs watch, which tracks vital signs, including pulse oximetry, pulse rate, blood pressure, and temperature.
- AiCure offers a medication adherence solution employing artificial intelligence, which visually confirms medication ingestion on any smartphone.
- mTelehealth markets an mTeleHealth Remote Patient Monitoring System that is a solution to remotely collect, store, and report health information.
In February, Current Health, a remote patient monitoring platform, launched Community, part of its effort to build diverse longitudinal datasets for decentralized clinical trials. With its FDA-cleared remote monitoring system, Current Health collects hospital data, such as respiratory rate, heart rate, temperature, oxygen saturation and movement, from patients at home. The system can integrate other monitoring devices, such as those from VivaLNK, Dexcom, and Omron.
Last December, VivaLNK, a provider of RPM solutions, expanded its Medical Data Platform for global partners. The platform is designed for rapid development and deployment of RPM applications, and ensures patient vitals can be captured continuously and delivered to clinical applications.
The platform powers RPM and telemedicine for more than 90 digital healthcare technology partners, and includes applications, such as clinical trials, cardiac monitoring, and remote and in-patient vitals monitoring. The expansion of the Medical Data Platform includes: Vitals Data Service, a turnkey solution designed for continuous remote patient data capture and delivery for clinical trials, and the Sensor Data Kit of wearable sensors and software tools.
Unlocking Patient Data
RPM technology, with the help of wearable sensors and intelligent devices and apps, is enabling clinical trial operations teams to unlock and manage more patient data than previously possible. Obtaining quality data over a continuous period of time helps teams assess how a drug is truly impacting a patient in real time, placing that patient at the center of a clinical trial. RPM enables pharmaceutical companies and clinical research organizations to execute novel clinical trials – virtual trials – that offer a real-time connection with patients.