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Thought leadership and innovation for the Pharmaceutical Industry

Telemedicine – or remote visits – has traditionally been used for patient-physician consultations and the delivery of health care. Today, the value of telemedicine in clinical trials is creating a buzz. With the promise of greater access to research and reduced attrition, what else is driving pharma’s move towards decentralized trials?

 

For Boehringer Ingelheim, patient-centricity is at the heart of its drive to conducting decentralized clinical research, says Brandon Maggio, Associate Director. “A patient’s geographic location and/or socioeconomic status is one of the largest barriers to enrollment and retention in clinical trials. Telemedicine addresses this while also increasing the probability of improved patient diversity. This gives a more accurate representation of a given disease population and how an investigational medicinal product will act within that population.”

Janssen’s interest is driven by the direct-to-patient model’s promise to improve the diversity of trial participants and patient access to clinical trials, says Dimitri Talantov, Senior Medical Director, Janssen Clinical Innovation. “Additionally, by improving clinical operational efficiency, novel medicines make it to patients faster,” he adds.

 

Greater access to trials and a faster path to market benefits both pharma and patients. But, to claim this model of clinical research is patient-centric requires more evidence of patient value. So, just how patient-centric is telemedicine? 

 

Creating connections

“The utilization of telemedicine in clinical research enables patients to engage with investigators and treating physicians more efficiently,” says Maggio. And this is what patients want. They don’t want to enter a trial and be left to wait until its conclusion for any human interaction; they want to feel like part of a team throughout the trial journey. Far from creating a sense of remoteness, decentralized trials that utilize telemedicine can prevent patients feeling isolated by creating more timely and personalized touchpoints.

 

As an example, doxy.me – a telemedicine platform developed by Professor Brandon Welch and colleagues at the Medical University of South Carolina – connects doctors and researchers via video. Currently, 65,000 doctors use doxy.me with about a million telemedicine minutes a week and 8,000 to 9,000 video sessions a day. 

 

This is primarily delivering telemedicine health care, but doxy.me also supports clinical researchers to recruit and meet with participants. “The workflow is very similar to traditional telemedicine services, but we have integrated the ability to obtain consent via teleconsent, which is simply the ability to complete a consent form over telemedicine,” says Professor Welch. “So, researchers can use doxy.me to obtain consent and then to meet up with their participants throughout the study.”

 

Boehringer Ingelheim is achieving similar patient-researcher connection via Science 37’s Network Oriented Research Assistant (NORA®) platform. NORA® allows researchers to interact with patients throughout a clinical study via a video conferencing feature. “The platform can also be used to remind patients to take their study medications at the proper time and let researchers know if participants are adhering to the study requirements,” says Maggio.

 

NORA® enables such efficiency through the direct capture of data with automatic integration to another electronic data capture system. “This allows for more real-time access to, and monitoring of, the data being collected within a clinical trial. One could argue that such features beneficially impact overall trial oversight,” says Maggio.

 

Balancing trial participation and life

A big question is whether patients really want to take part in clinical trials from their own home. Janssen has asked clinical trial participants and they do, indeed, like being able to participate remotely as a result of telemedicine. 

 

“Moreover, other pharmaceutical companies, patient advocacy organizations and technology groups have been collecting patient input from across various disease areas and geographies with similar results,” says Talantov. “One of the most common and strong messages from these surveys is that patients need an adequate balance between clinical trial participation and life.” 

Telemedicine allows that.

 

Patients also want a ‘human’ experience, says Professor Welch – that is, they get easily bored with traditional ways of collecting data such as surveys, which is why attrition is so high in survey-based research. “Capturing data via surveys just isn’t intuitive or natural,” he says. 

This is one of the driving forces behind doxybot, which Professor Welch describes as “a chatbot that replicates how clinicians communicate with patients, asking questions and adapting additional questions based on previous answers.” 

 

Ultimately, doxybot, which Professor Welch plans to incorporate into the doxy.me telemedicine platform, is “a human conversation to collect complete and accurate data while also keeping people engaged.” 

 

The future goal is for an automated process that doesn’t require research assistants to obtain consent or collect data. Patients will be able to check in, express interest in a study, watch an educational video about the study, complete a teleconsent form if they wish to move forward, and then answer any necessary questions via a chatbot. The aim is for an agile process, that is more akin to human-to-human interactions. 

 

Not for everyone – yet 

There doesn’t seem much not to like about telemedicine in clinical trials. However, Talantov does caution that the remote aspect of a visit is not always an ideal solution for everyone. “Face-to-face interactions with physicians and study teams are one of the most important patient engagement factors,” he says. “We need to understand when, for which patient population, and which technology-mediated communication will be most advantageous and when it will not be appropriate for a particular patient engagement.”

 

Another potential challenge is that the patient-centric trial model is a relatively new concept in clinical research. “Initially, it may be time-consuming and burdensome to set a novel infrastructure and to get sites and patients used to the new system or device to enable remote data collection,” says Talantov. “When planning remote visits in clinical studies, we need to carefully evaluate if the benefits outweigh the risks and workload needed to implement a new model.”

 

On a similar note, Maggio says, “Some of the challenges of using telemedicine in clinical trials could be around education and training in telemedicine techniques and etiquette, as well as training on the digital software and tools being utilized within a trial. All of this would be in addition to standard trial training requirements.”

 

Professor Welch agrees that novel models of clinical trials can be challenging to operationalize. However, he says, “As patients become more comfortable with the technology, they are going to demand it. We are starting to see that trend in our culture today. Who goes to the bank anymore? Hardly anyone; we do everything online. Healthcare and clinical research has been lagging in this respect, but people no longer want to go to the clinic for a prescription or to take part in a study. The more people see the possibilities of telemedicine, the more they will demand it.”

 

Advancing the telemedicine model

Telemedicine appears to be both patient-centric and researcher-/physician-centric, so how exactly does the industry move forward with this model?

 

“Decentralization is one of the significant trends in both clinical research and health care at large,” says Talantov. “Currently, health care is driving adoption of telehealth. Moving forward, sponsors and investigators need to actively explore patient-centric clinical trial models to achieve more accessible, more comfortable and more efficient trials.” 

 

Professor Welch echoes this emphasis on efficiency. “Economically, traditional clinical trials are not sustainable due to the time and costs that go into participants and researchers travelling to trial sites,” he says. “Researchers need to embrace this technology now because it will become an integral component of future clinical trials.”