Clinical trials are a necessary—but sometimes messy—part of a long journey in creating healthcare interventions that work. They are costly, take a great deal of time, demand intensive effort, and can have a very high failure rate. All of these factors drive up the costs of medications.
On average, it costs about $1.1 billion (adjusted to 2014 dollars) to develop a new drug. And typically, 90% or more of the development costs are incurred in Phase III trials, wherein a drug must prove its effectiveness in large, double-blind, Placebo-controlled and randomized studies to get FDA approval.
Of all the drugs tested, about 30% clear Phase I trials, 14% clear Phase II trials and only 9% pass through Phase III trials. And this entire process may take anywhere from 6 to 11 years, not to mention the time spent on preclinical drug research.
The mHealth Advantage
On the digital health landscape, various mHealth tools—such as remote patient monitoring, medication reminder services and even social media—can complement different stages of the long clinical trial process.
Remote Patient Monitoring Can Reduce Data Collection Challenges
Finding suitable patients for trials in large numbers and retaining them until completion can be a difficult task, especially in the case of rare diseases. Trial subjects not only have to take the medications on time, but have to report regularly to the trial site for testing and evaluation.
If the trial site is too far or if the frequency of visits is too demanding, chances are high that a significant number of patients may drop out of the trial—which can negatively impact the sample size.
Remote patient monitoring technologies can help do away with these recruitment and retaining problems to a large extent. After an initial face-to-face session, all or most of the required measurements of patients can be taken using existing market-proven and cost-effective telemedicine and patient-monitoring systems.
GlaxoSmithKline has demonstrated the use of mHealth technologies in collecting large amounts of reliable clinical data in a safe and secure way in real-time in compliance with FDA regulations in its Human Performance Lab project.
AMC Health is offering a software application that can be run on tablets and smartphones to enable collection of patient-reported data in clinical trials.
Such remote capabilities reduce logistical burden, as well as the accompanying costs, and facilitate patient-centric clinical trials.
Video Conferencing Reduces the Need for Patient Visits
Video conferencing technologies, which are widely being used in telemedicine and telehealth projects, allow regular two-way communication between research staff and trial subjects without the latter having to be physically present at the trial site. It also helps researchers make sure that all protocols are being followed in the clinical trials.
The U.S.-based Mayo Clinic Health System has already deployed one such telemedicine platform that connects patients and physicians in real-time at a very low cost.
The Northern Maine Medical Center is also using a telehealth platform consisting of cameras, monitors and wireless devices to provide real-time, video-based trauma consulting to replace the traditional telephone consulting approach.
mHealth Tools Improve Medication Adherence and Monitoring Compliance
Making sure that trial subjects are taking their medications properly and that the whole clinical trial process is being monitored in compliance with standards are two important factors affecting the quality of research outcomes.
In the traditional approach, there are not many fool-proof ways to tell if subjects are taking their medications as instructed. A host of mHealth medication adherence technologies can help solve this problem in clinical trials. Further, when a trial subject knows that his or her adherence is being monitored, that in itself acts as a major compliance booster.
mHealth Can Assist in Recruitment of Trial Subjects
Finding patients who are willing to participate in trials and fit the target criteria can be an arduous process if the disease is rare or the subpopulation is spread over a wide geographic area. Too few enrollees, or too high drop-out rates in often long-running clinical studies can adversely impact the sample size and the conclusions that can be drawn from it.
Social media can be a useful tool to recruit trial subjects, especially for rare diseases. Use of remote patient monitoring technologies can decrease the challenges involved in gathering medical data from patients spread over a wide area.
The U.S.-based pharma company, Transparency Life Sciences (TLS), has effectively used crowd-sourcing techniques to recruit trial subjects and telemonitoring solutions to significantly bring down costs in Phase II clinical trials for its new investigational drug, lisinopril, to treat multiple sclerosis.
The Pace is Picking Up
With pharma giants such as Pfizer and GlaxoSmithKline betting big on leveraging mHealth technologies in the drug development process, the use of mobile health tools in clinical trials will see a further boost in the near future.
As mHealth adoption demonstrates the benefits that can be accrued through the use of mobile devices in a safe and effective way, concerns about data quality and regulatory compliance will be reduced, and the potential for mHealth to lessen the burdens of drug development costs increasingly optimized.
Shiva Gopal Reddy has a Bachelor's degree in Physics and a Master's in Applied Psychology and writes frequently on the latest research, impact, happenings and trends in digital health technology.