Home visits performed during a clinical trial not only increase retention but also reduce the load on clinical sites, allowing for the recruitment of more patients or the conduct of more trials. Due to the complexity of coordinating home visits for clinical trials, some CROs have developed offerings that are unique to this type of patient care. With this approach, patients can receive their clinical trial treatments without leaving their homes. This considerably minimizes the stress on patients and their loved ones by reducing the number of visits to research locations. As a result, the clinical research organization working on the Veristat project now offers a wide range of services and procedures that were once only available at clinical research sites. These are now given to everyone who takes part in a home-based study.
Meeting patients where they are
Meeting patients where they are in virtual clinical trials predates the epidemic and enhances patient conveniences and experience. Changing technologies and services have made it possible for clinical trials to move closer to participants. Tools like eConsent, remote patient monitoring, telehealthcare, and eCOAs (electronic clinical outcome assessments) help researchers engage with trial participants even when they can’t visit them in person. More treatments can be performed outside of research sites thanks to home and mobile healthcare, along with alternative-care settings.
Traversing a new regulatory landscape
All players in the clinical research industry—regulators, sponsors, contract research organizations, trial sites, and patients—are adapting to rapid change. There is greater room for innovative technologies and startup inventions to meet the rising demand for clinical trial data sources and remote patient connections. Patients are the primary focus of clinical trials, and soon the industry will develop more efficient methods of conducting clinical trials electronically with connected devices, drug delivery to the patient’s home, and timely virtual contact, resulting in more precise data capture, greater transparency, and greater patient trust.
How technology helps
High-speed Internet access on smartphones and tablets has greatly simplified the process of collecting real-time data and remotely monitoring patients’ symptoms and their activity levels. Researchers are interested in learning whether or not this idea can be implemented successfully and whether or if it enhances the standard of care for patients. They also can assess the potential benefits of virtual visits in terms of reducing caregiver stress and travel time. Researchers are increasingly using mobile devices like smartphones and tablets to collect data from study participants, including taking vital signs, measuring the intensity of symptoms, and providing patients with consent forms and questionnaires. Patients’ pill boxes not only track how much they move, but they also have sensors that let researchers know if they are taking their pills as prescribed.
The shift from paper to eCRFs a decade ago improved clinical trial efficiency, and the trend towards remote-based clinical trials may transform the business in 10 years. As the number of people who can take part in clinical trials grows, study participants will have less trouble and get better care at home. Because of this, it is important to think about how to include this method in a full clinical development strategy.