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Telehealth Tools Impact the Clinical Trials Sector

By Vera Gruessner

- The discovery and approval process of drug development can often span many years and clinical study researchers as well as sponsors and medical technology innovators are coming together to reduce this gap. On February 18, many representatives from the healthcare technology industry came together at the Close the Gap Now conference in New York City.

Among the many representatives at the conference, AMC Health, a provider of telehealth technology solutions, presented their findings on the benefits of incorporating mobile technology in clinical studies, according to a company press release.

Michael O’Brien, President of AMC Health’s Clinical Trials Division, based in New York City, spoke with on the tools he finds most effective in promoting remote care and patient engagement in clinical studies.

“Clinical researchers can collect biometric data, patient-reported outcome data, and create a virtual video connection with a patient at home,” O’Brien discussed some potential capabilities of telehealth tools. “In today’s world, it can be a mobile device or it could be a BYOD downloaded app to a particular device that can collect biometric data from sensors that are either inherent in the device or connected by Bluetooth.”

O’Brien went on to explain how new tools could take patient surveys, allow for secure messaging, and engage patients in dialogue about their condition. The addition of high quality bi-directional video can enable clinical trial specialists to conduct a virtual visit with their subjects and ensure they are using the proper techniques in collecting medical data.

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“The element of video provides a richer virtual visit experience for both the patient and the clinical trial investigator,” O’Brien said. “With video connectivity, they can direct you, observe you and engage you in questions and answers. They can have you perform tests of motor function that can be directly observed. They can ensure the use of proper technique in terms of collecting biometric measures and view that data in near real time.”

Technologies with these capabilities are able to increase the recruitment of subjects across a broad geographic spectrum, providing access to those who are unable or unwilling to maintain the travel schedule required for most trials. Other benefits of telehealth tools include collecting data over the course of the subjects’ home life activities and providing a clearer understanding for researchers on whether to alter their study or shut down certain trial stages.

“We’re going to improve the connectivity to patients that to this point has been limited to in-person visits in a more convenient way for clinical subjects to participate,” O’Brien explained. “We’re going to be able to collect more data that’s more immediately available for analysis.”

“And that may advise a clinical team to alter treatment of a patient, or shut down a study early,” he emphasized.

The biggest risk of telehealth technology, according to O’Brien, is the execution of technology into a clinical trial setting in which both patients and researchers may not be familiar with the new tools. Greater training of both staff and subjects will mitigate the effects of this potential risk.

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Including telehealth in the clinical trial sector is hoped to reduce dropout rates of subjects among promising studies. While there are a limited number of telehealth pilot programs taking place around the nation and exact numbers on dropout rates are not available, there is belief that including these technologies will increase retention and improve patient engagement.

“If you can engage a patient and you can make it more convenient for them to participate, the combination of those two things can keep patients more interested in participating,” said O’Brien. “Everyone that we talk to – whether they are patients, clinical coordinators, or sponsors – innately understands the potential benefit that can come from improved recruitment or retention.”

Patient privacy and security is vital in the telehealth sphere and vendors continue to develop secure technologies that are validated to ensure data integrity is maintained, and is provided securely to the clinical study team. Since this is a highly regulated field, vendors follow the highest level of security with regard to video messaging and other mobile tools. Quality management systems are often used to test compliance of new features or updates.

“In each one of these studies, there is a survey questionnaire given to patients to ask their level of satisfaction, what was different about their experience, what they liked about it, [and] what they didn’t like about it,” O’Brien spoke about patient satisfaction with remote care. “In conversation with patient groups and sites that are engaging those patients, the initial benefit and value to patient satisfaction is the convenience to participate from home.”

The burdens of travel or discomfort with the collection of certain data at a clinical study site often leads to higher dropout rates. Telehealth, on the other hand, solves these issues by providing technologies that collect data in the comfort of one’s home.

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Nonetheless, some clinical trial subjects are wary about how the technology will affect their home life. This leads developers to be careful in implementing an effective strategy when introducing technology into the home. In order to ensure higher satisfaction, there is greater stress put toward respecting patients’ home life conditions and collecting data in a non-disruptive manner.

“The technologies that are the next frontier are those that can be integrated and non-disruptive to daily living, while recognizing and supporting patients as they participate in this advancement of new drug development,” O’Brien concluded with the next steps developers will need to take.


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