“This is one of the first studies to evaluate the ability to conduct traditional clinical trial visits remotely directly in a participant’s home,”
New York, NY (PRWEB) June 22, 2016
AMC Health, a leading provider of telehealth solutions, and University of Rochester Medical Center announced today that they have enrolled their first patient in a remote clinical trial in patients with Parkinson’s disease. The study is part of a larger Phase III clinical trial, and will integrate the use of video, biometric data collection, and onscreen assessments.
“This is one of the first studies to evaluate the ability to conduct traditional clinical trial visits remotely directly in a participant’s home,” said URMC neurologist Kevin Biglan, M.D., the principal investigator of the REACT-PD study. “If successful, the study will help lay the foundation for the virtual conduct of increasing proportions of clinical trials, reduce the travel and time burdens on research participants and their families, and increasingly allow anyone anywhere to participate in research.”
Approximately 40 participants at 10 clinical research sites will be enrolled. The sites were chosen based on the number of eligible participants and their willingness to participate. Participants will complete several virtual visits over the course of the study in conjunction with their in-person visits in the larger study. Virtual visits will be conducted via the telehealth platform developed by AMC Health which deploys a mobile solution including a smart phone and biometric sensor devices to collect a range of data. The study will measure the feasibility to conduct remote assessments, the reliability of remote assessments compared to the in-person assessment, the value of virtual research visits as measured by time and travel saved, and the preference of patients to participate in remote visits.
“This study is another example of telehealth’s capability to remove the logistical barriers for patients participating in clinical trials, while ensuring the quality of the data collected” said Michael O’Brien, President, Clinical Trials Division, AMC Health. “The life of a Parkinson’s patient can be challenging enough. Telehealth can decrease the burden on these patients and their caregivers by allowing clinical trial visits to be conducted in the comfort of their home.”
AMC Health has been performing groundbreaking work in remote patient monitoring and engagement since its founding in 2002. Launching its Clinical Trials division in 2013, the company continues to leverage its expertise in telehealth across the healthcare continuum to advance innovation in clinical trials. AMC Health’s Clinical Trials platform is a 21 CFR Part 11 compliant solution to manage the complexities of clinical trial data collection.
REACT-PD will be the first sub-study within an ongoing, randomized, double blind, multi-site clinical trial to evaluate the ability to conduct a virtual clinical trial visit directly in the participant’s home in comparison to in-person visits. The results will inform the feasibility, reliability and value of conducting clinical trials virtually and can serve as a model for increasing access, participation and retention in future clinical trials. The study is being led by researchers at the University of Rochester with support from the National Institute of Neurological Disorders and Stroke.
AMC Health’s e-Visit solution allows study subjects to participate in video visits from home, which enables research sites to collect biometric and subjective data, remotely. This will allow patients who live far from a traditional clinical trial site to participate via virtual visits in place of, or as a complement to, face-to-face site visits. Among its many benefits, virtual visits can expand the geographic recruitment area by reducing the travel and time burden on patients.
Click to Tweet: @AMCHealth and @UR_Med deploy #virtualvisit for Parkinson’s Phase III clinical study: REACT-PD #telehealth #clinicaltrials #evisit
About AMC Health
AMC Health’s Clinical Trials division provides a suite of solutions on a telehealth platform for Study Sponsors, CROs and Sites, to remotely collect biometric, observational and subjective data from study subjects at home, for use in clinical trials. AMC Health’s Clinical Trials platform is a 21 CFR Part 11 compliant solution to manage the complexities of clinical trial data collection. The platform utilizes a toolkit of Bluetooth-sensor devices, smartphone mobile applications and bi-directional video to create an e-visit to replace or augment traditional study visits. For more information, visit http://www.amchealth.com/solutions/clinical-trials.php
About University of Rochester Medical Center
One of the nation’s top academic medical centers, URMC forms the centerpiece of the University’s health research, teaching, patient care, and community outreach missions. Over the last 5 years, URMC has garnered more than $1.28 billion in biomedical research, landing the University of Rochester School of Medicine and Dentistry in the top one-quarter of U.S. medical centers in federal research funding.
Mark Michaud, University of Rochester Medical Center