Decentralized/Virtual Clinical trials are being transformed by swiftly emerging technologies. Direct-to-patient models require trial data to be protected and accurate. Not all organizations are equipped to do that. Yourway is.
The COVID-19 pandemic has forced the development of novel practices that have augmented production and how business is performed in many industries. Decentralized clinical trials utilizing direct-to-patient services is one significant example.
In times of great strife, adaptation seeds progress, and new technologies have emerged that have positively impacted how clinical trial data is obtained and retrieved for more accurate analysis.
According to Leandro Moreira, Senior Vice President of Corporate Development of Yourway, global scaling and interoperability that are necessary for successful implementation of global clinical studies have been enabled through the early adoption of cloud-based technology followed quickly by increased availability of direct-to-patient data-capturing apps, wearable devices and platforms.
“These technologies and tools designed to capture patient data with higher accuracy are very valuable to support decentralized/virtual direct-to-patient trials,” Moreira emphasized. “Technology-enabled decentralized clinical trials represent a more patient-centric approach to how studies are conducted.”
The key areas in the process of decentralized trials that are augmented by new technologies include resolving the challenges of patient recruitment and retention as well as minimizing the burden on patients who can now receive treatment at home without having to travel to a clinic – this is highly significant in that it dramatically enhances comfort and compliance. Further, more patients are likely to enroll to participate in a clinical study and will be less inclined to drop out before study completion.
Patient engagement and study protocol compliance are also enhanced as a result of increased access to behavioral insights and the availability of nudges reminding patients and providers about important activities to be completed.
The sea change inspired by new technology that resonates is that clinical trials are more personalized. This is a direct result of how data science helps identify individual patient behavior, and how behavioral science facilitates the development of behavior interventions based on unique patient characteristics.
Another critical component of the direct-to/from-patient process is the delivery of investigational medical products (IMP) and ancillary supplies to the patients’ homes, the transportation of samples from the patients’ homes to laboratories, and the reverse logistics of unused IMP for accountability and destruction.
Additionally, Moreira explained, monitoring technologies continue to evolve to provide additional data points and features such as geofencing, monitoring of temperature, location, exposure to UV lights, tilt, and vibration. The increased availability of 5G-enabled technologies will spur evolution of how these communicate, e.g., the accuracy, speed, type, and size of data being transmitted will significantly increase, thus adding extra visibility to logistics processes.
Availability of 5G networks is expected to improve all critical components of clinical trials, including telemedicine, use of wearable devices for continuous monitoring and delivery of information to patients, transfer of large medical files, and faster and more accurate data supporting clinical trial logistics. “Stakeholders will be able to make better, faster, and more informed decisions as a result,” stated Moreira.
In tandem, the use of Internet of Things (IoT) devices in the direct-to-patient studies contribute to data fluidity since it helps create a connected healthcare system with near real-time data access. The type and quality of data and the speed in which data are being transferred are also positively impacted by the utilization of artificial and cognitive intelligence in many areas of the clinical study healthcare eco-system.
The continual growth activity of the IoT, generated by cloud computing, business analytics tools, wearable medical technology such as wearable ECGs, wearable blood pressure monitors and biosensors all combine to significantly improve the generation of evidence and analytics, near real-time capturing of adverse events, and overall availability of more accurate information to patients, study teams and everyone involved in the clinical study.
“IoT has helped add extra efficiency to how Yourway operates,” affirmed Moreira. These efficiencies are embedded throughout Yourway logistics value chain, including warehousing, clinical packaging and biopharma operations, and transportation, including direct-to/from-patient services. Additionally, Yourway’s GMP depots are equipped with IoT devices that continuously complete important tasks such as monitoring temperature of all our temperature-controlled storage rooms and generating alerts when needed.
In addition, these devices add accuracy to inventory management system and practices. Yourway’s transportation tracking platform also relies on the utilization of IoT monitoring devices to capture data, such as location, temperature, tilt, exposure to light, and vibration. “All this combined helps us protect product integrity, promote patient safety, and add the level of desired visibility that clients value,” said Moreira.
Currently, there are several ongoing projects at Yourway to further modernize its operations by adopting additional technologies to benefit client experience and support the growth of its global footprint. With the implementation of new technologies, Yourway has increased ability and efficiency to monitor assets, shipments, and activities in real time and to measure its performance across our global network.
Yourway’s goal is to continue to automate its business processes to reduce manual interventions, which would improve quality and consistency, as well as to apply analytics to identify continuous improvement opportunities and best practices that differentiate Yourway from other providers.
“Other providers with systems that are not integrated or well linked and capable of capturing and managing clinical trial data in a reliable and consistent way are obsolete,” Moreira observed. “The industry today is more equipped with new technologies that help make better sense of big data by analyzing the relationships between various data points instead of just analyzing data itself. Data integration is paramount for organizations to benefit from technology trends.”