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Summary: A ‘digital tsunami’ has modernized banking, finance and entertainment, allowing entry of unexpected and non-traditional competitors. Telemedicine promises to do the same to healthcare, improving patient access to care while bending the cost curve.  This adoption is driven by widespread availability of smart phones (approximately 2 billion globally), physician shortages, and economic constraints.

Broadly, telemedicine is the use of information technology to deliver healthcare services, and we are beginning to see its impact in modernizing healthcare, which can be extended to clinical drug development.

As a substitute for an in-person visit to a physician or ER, telemedicine offers a promising way to deal with imbalances between supply (physician shortages) and demand (need for clinical care). In the U.S., an estimated one million video telemedicine visits occurred in 2015; the telemedicine market value is currently $6.5 billion/year, and forecast to grow to $24 billion by 2019.

‘Digital tsunami’ alert for healthcare

Mobile and broadband have reshaped industries such as banking, financing and entertainment, opening markets to unanticipated new and non-traditional competition. Consumer experiences have been shaped by interactions with digitally enabled industries such as banking, creating demand for greater access and convenience in healthcare services and by extension, clinical research. Key market drivers include:

The U.S. Department of Veterans Affairs (VA) has been a leader in evaluating telemedicine, and has invested more than $500 million in this area. In fiscal year 2014, the VA had nearly 700,000 veterans participate in telemedicine visits with more than two million episodes of care. The VA’s own analysis of the program found that veterans who received healthcare services via a telemedicine platform had 34% fewer readmissions, and when admitted, had 42% fewer bed days compared with veterans who received care through in-person encounters. The VA also uses telemedicine for delivery of ancillary services – such as teleradiology, telepathology, teledermatology – images are acquired or captured routinely in a clinic, and the data is forwarded to remote specialists for review. Following review by the specialist, the results drive important treatment decisions by the healthcare team.

Kaiser Permanente has also been an early adopter and is implementing telemedicine for access to primary care and specialty care. In addition, other payers such as UnitedHealthGroup are expanding access to telemedicine services across their plans. In contrast, Medicare, has limited coverage of telemedicine services.

Telemedicine could improve management of chronic diseases. For example, a study found that use of remote monitoring of implantable cardioverter defibrillators was associated with lower risk of adverse outcomes, including mortality.

Telemedicine and Clinical Development

Telemedicine platforms could be used to conduct clinical trials.  Some or all study visits could be done remotely (i.e., a virtual visit).  Biosensors and medical devices could be incorporated into the trial and provide a rich stream of continuous or near-continuous data.

It is, however, important to ensure that it is used appropriately in clinical development. Careful consideration is required regarding its application, including the study phase and indication and overall study objectives.

When applied appropriately to clinical development, telemedicine may offer the following payoffs:

  • Reduced patient and partner/caregiver burden involved in clinical trial participation
  • Accelerated recruitment, and extension of the geographical reach of sites
  • Increased convenience, with a likely positive impact on retention
  • Enhanced safety surveillance
  • Cost savings
  • Increased site capabilities.

Moreover, technology could help meet FDA’s demand for clinical trials to enroll a more diverse patient population.  The technology extends geographical reach of research sites.   There exists today, a HIPAA-compliant app that enables clinical and research staff to communicate with patients and their family members easily through encrypted video access via iPad to remotely located interpreters for non-English speakers or deaf individuals.

Teams involved in clinical research should “think like a software company” to consider how mobile technologies in general and telemedicine might increase site capabilities. There are learnings from the Uber ride sharing model, where a mobile technology platform (software) allows the company to link drivers to consumers. But the outcome of this powerful software platform is increased supply of both drivers and cars, and improved customer satisfaction.

Learning from ride sharing platforms, there is an opportunity to leverage telemedicine platforms to increase access to research subjects. One example is to connect Primary Care Practitioner (PCP) sites through a telemedicine platform with a central nervous system (CNS) specialty site to have greater access to new sources of patients.  Many CNS conditions frequently are treated by primary care physicians (e.g., early or prodromal Alzheimer’s disease and depression). Yet, CNS specialty sites typically are selected, almost exclusively to conduct trials in these indications because specialized expertise is needed to confirm diagnosis for study eligibility and to conduct various assessments or ratings that measure change during a trial. 

However, it is now possible to bring in specialized knowledge from a CNS research site to a primary care site. By connecting the CNS specialty and primary care research sites with active clinical practices, a new source of patients is realized (i.e., patients who receive their healthcare services from the primary care practice).  The CNS expertise is brought in virtually from a ‘hub’ site, to support the confirmation of the diagnosis, the determination of eligibility for the trial and assessment of symptoms during the trial.  The basic idea is that the technology creates value by allowing a recombination of research assets. The value created in this example is related to greater access to new patient populations and the ability to support primary sites to conduct studies in new indications.