This article discusses key concepts in patient preference assessment of particular importance for regulators and researchers that are addressed in the MDIC Framework for patient centered benefit-risk assessment as well as the unique public-private collaboration that led its development.
Increasing digitization across the healthcare continuum has revolutionized medical research, diagnostics, and therapeutics. This digitization has led to rapid advancements in the development and adoption of Digital Health Technologies (DHT) by the healthcare ecosystem. With the proliferation of DHTs, the term ‘digital biomarker’ has been increasingly used to describe a broad array of measurements. Our objectives are to align the meaning of ‘digital biomarker’ with established biomarker terminology and to highlight opportunities to enable consistency in evidence generation and evaluation, improving the assessment of scientific evidence for future digital biomarkers.
With an increasing interest in cocrystals due to various advantages, demand for large-scale cocrystallization techniques is rising. Solution cocrystallization is a solvent-based approach that utilizes several single-component crystallization concepts as well as equipment for generating cocrystals. Solution-based techniques can produce cocrystals with reasonable control on purity, size distribution, morphology, and polymorphic form. Many of them also offer a scalable solution for the industrial production of cocrystals. However, the complexity of the thermodynamic landscape and the kinetics of cocrystallization offers fresh challenges which are not encountered in single component crystallization. This review focuses on the recent developments in different solution cocrystallization techniques for the production of pharmaceutically relevant cocrystals. The review consists of two sections. The first section describes the various solution cocrystallization methods, highlighting their benefits and limitations. The second section emphasizes the challenges in developing these techniques to an industrial scale and identifies the major thrust areas where further research is required.
Real-world data sources, including electronic health records (EHRs) and personal digital device data, are increasingly available, but are often siloed and cannot be easily integrated for clinical, research, or regulatory purposes. We conducted a prospective cohort study of 60 patients undergoing bariatric surgery or catheter-based atrial fibrillation ablation at two U.S. tertiary care hospitals, testing the feasibility of using a patient-centered health-data-sharing platform to obtain and aggregate health data from multiple sources. We successfully obtained EHR data for all patients at both hospitals, as well as from ten additional health systems, which were successfully aggregated with pharmacy data obtained for patients using CVS or Walgreens pharmacies; personal digital device data from activity monitors, digital weight scales, and single-lead ECGs, and patient-reported outcome measure data obtained through surveys to assess post-procedure recovery and disease-specific symptoms. A patient-centered health-data-sharing platform successfully aggregated data from multiple sources.
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