Contributed Commentary by Julia Lakeland

November 16, 2017 | Patients are invaluable to the clinical trial process, but in an increasingly competitive and heavily regulated market there is an apparent lack of patients available to participate in clinical trials. Patient recruitment and retention is a common challenge biopharmaceutical companies face, and they are seeking new and innovative direct-to-patient (DtP) solutions that can increase their outreach to the patient community. Existing and emerging technologies such as Interactive Response Technology (IRT), e-Clinical Outcome Assessments (eCOA), mobile apps, wearables, and remote-based monitoring provide the support infrastructure for clinical trial documentation, processing, randomization, communication, and supply management which make remote, site-less, or virtual DtP trials possible. These technologies can make participation in studies attractive to patients who might not otherwise enroll in a study, and can also benefit biopharmaceutical companies through optimized recruiting costs, improved patient interactions, compliance, and quality in data collection and visibility.

In the near future, physical sites could be replaced with virtual sites. Highly patient-centric, DtP trials could use social media platforms to recruit patients to the study, and patients could fill out all of the forms necessary to participate electronically. They would then be connected remotely to investigators and sites. Once enrolled, devices for communication, diagnostics, and treatment could be delivered directly to patients with the resulting data collected via a network of interlinked systems and sent electronically to sponsors and investigators for analysis.

It’s an interesting concept and some critics may feel it is not achievable for all patient groups, which is a reasonable argument.  However, considering how the world has changed in the last 10 years, and the fact that 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, eHealth mobile apps can be discreet and noninvasive to the patient’s lifestyle.  This is an important trend in the healthcare 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 the 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, we announced with a collaboration with Sanofi to advance the use of wearable devices to collect data from trial participants. We’ll examine how data collected from several wearable devices can be streamlined into a single, scalable data system that provides valuable insights.

Integrating Mobile and Sensor Technology With Clinical Trial Systems

The use of technology can improve compliance to the protocol as well as improve patient safety. “Smart packages” for example can monitor dispensing methods and patient compliance while tracking the trial drug from the supply chain to its use in a patient’s home. Monitoring the entire end-to-end supply chain of custody from primary packaging through to the use of the medication in the patient’s life and not forgetting the returns, reconciliation, and destruction of the study medication provides valuable real-world evidence to support regulatory submissions.

Over the past few years, IRTs that provide randomization and trial supply management capabilities and electronic data capture systems have become standard tools for clinical trials to facilitate data collection and ensure that end-to-end supply chain custody is captured, recorded, and reported. An IRT system with patient-centric workflows combined with near-real time monitoring of cold chain shipments and in-pack temperature monitoring conveniently stored in the patient’s home provides a consolidated view of all clinical trial activity. The setup of such IRT systems can also be modified to include mobile apps for patients (or home care attendants) to confirm that they have received a shipment and taken their medication. Mobile applications that connect medical devices and drug packages can issue reminders and give sponsors and investigators access to data which can improve compliance to the protocol. Mobile applications can also be used to engage patients throughout the course of the trial. 

Next generation sensors, wearables, and mobile applications can be used in studies to monitor health and increase engagement with, and communication between, the sponsor, investigator, site and patient. To comply with data privacy regulations and prevent study unblinding, the IRT system should include a protected area to store the patient data without contaminating the study data. It is also important to remember that medications must not only be delivered to the patient’s home but they must also be returned to the clinical site or depot for drug accountability and to destroy unused medication. Returned medication must be destroyed in a GMP-compliant manner so that a destruction certificate can be issued at the site or depot.

Overall, advancements in technologies are re-shaping the way developers conduct clinical trials, and could revolutionize the future of trial structure.