The FDA recently revamped the methods it uses to determine which foreign and domestic drug manufacturing sites warrant inspection or other types of surveillance and at what frequency. The agency also introduced a multiyear resource planning process that will enable it to better use resources and plan frequencies of product sampling as well as inspections.
This two-part series of articles looks at how the application of new technologies around data analytics has proven beneficial for the biopharmaceutical industry and regulators alike. The first article explored how technological advancements such as use of real-time data, predictive modeling, and artificial intelligence are gaining regulators’ acceptance and enabling the more efficient development of effective drugs and treatment solutions. This article examines the current environment of collaboration in the industry, along with technologies that will open opportunities to utilize data across life science sectors, including cross sector intelligence (CSI), the convergence of information across multiple sectors, enabling intelligent data-driven decision making.
Advancements in biosensor technology are becoming increasingly common in the consumer space, with wrists adorned with Fitbits or similar devices, clothing embedded with “intelligent” fibers, and personal safety devices seen in healthcare facilities across the nation. Our culture is increasingly accustomed to tracking health metrics through smartphones and simple recreational wearables. In the pharmaceutical space, we are now seeing where success in the consumer segment can translate to value-adds for clinical trials.
Previous articles on Clinical Leader have discussed the potential benefits of wearable devices for remote patient monitoring in clinical trials. In addition to possible increases in trial efficiency and reduction of costs, “wearables” have the potential to collect data better reflecting patient functioning and response in the real-world setting. According to the Clinical Trials Transformation Initiative’s Mobile Clinical Trials (MCT) Program, mobile devices, including wearables, offer the opportunity to collect more complete and informative data than ever before. Mobile devices may also reduce the patient burden in clinical trials, thus enhancing the patient experience. Companies are exploring the use of wearable devices in the post-marketing setting as well, as a component of patient care.
Integrating clinical trials within registries offers several opportunities: avoiding duplicative data collection, identifying and recruiting patients more efficiently, and accelerating decision making, to name a few. These efficiencies have the potential to reduce clinical trial costs — especially when a registry is used to conduct multiple clinical trials.