In the not-so-distant future, drug and medical device development could depend on virtual trial sites and a direct-to-patient (DtP) study model.
According to a recent Clinical Trial Supply survey, 24 percent of respondents currently use a DtP distribution model. One-third of those who don’t use DtP today, said they plan to adopt this model in the next 12-18 months.
The move to DtP studies is being driven by the desire to optimize recruiting costs, improve patient interactions, and leverage efficiencies in data collection/visibility using technology and a specialist service provider.
Technologies now in use for clinical trial documentation, processing, randomization, communication, and supply management make it possible for sponsors to conduct trials remotely. These technologies assure patients are carefully monitored while collecting the data required by regulatory agencies. These technological solutions include the following:
- Clinical trial management systems
- Electronic data capture
- Interactive response technology systems
- Electronic clinical outcome assessments
- Patient engagement apps
- E-medication for compliance tracking
- Wearables and diagnostic devices
Highly patient-centric, DtP trials can use social media platforms to recruit and qualify study patients. Patients that qualify would be connected remotely to investigators and sites.
Once enrolled, devices for communication, diagnostics, and treatment could be delivered directly to patients. The resulting data collected is then sent electronically to sponsors and investigators for analysis.
There are also technologies available that can monitor various data points and track drug location, status, and temperature. For example, “smart packages” can monitor dispensing methods and patient compliance while tracking the trial drug from the supply chain to its use in a patient’s home. Mobile applications that connect medical devices and drug packages can issue reminders and give sponsors and investigators access to data. Mobile applications can also be used to engage patients during the course of the trial.
Many consumers already use health technology in their daily lives, whether it is in the form of stand-alone activity trackers or applications on their smartphones. This is an important trend in the health-care industry.
Companies like Pfizer and Sanofi have piloted virtual clinical trials. Pfizer’s 2011 Research On Electronic Monitoring of Overactive Bladder Treatment Experience (REMOTE) trial was the first randomized clinical trial using web- and smartphone-based patient recruitment, enrollment and collection of study data. The trial did not require patient visit a physical study site.
Two years ago, Apple Computer launched ResearchKit, a powerful tool that it said would turn millions of the iPhones it manufactures into “a powerful tool for medical research.” Five studies were launched using the app, covering asthma, breast cancer, cardiovascular disease and Parkinson’s. Cornell University developed a similar application for use on smartphones that use the Android operating system.
In June of 2017, PAREXEL and Sanofi announced a collaboration to advance the use of wearable devices to collect data from trial participants. The companies are examining how data collected from several wearable devices can be streamlined into a single, scalable data system that provides valuable insights.
It is expected that next generation sensors, wearables, and mobile applications will be used in studies to monitor health and increase engagement with the sponsor, investigator, or test site. Remote patients’ data can be collected and placed directly into the EDC to increase compliance visibility, which in turn improves patient safety.
Trials designed around technologies familiar to consumers could motivate people to participate.
For more information on Direct to Patient clinical trials, download our white paper Assuring Success in Direct to Patient Studies: Key Considerations.
 “Assessing the Current and Future State of Clinical Trial Supply.” March 22, 2017. QuickStat.com. Accessed at < http://quickstat.quick.aero/current-and-furure-state-of-cts/>.