For automated capture of end points, aims were to (1) develop and test methods to collect end point–defining image files for patients participating in clinical trials, (2) develop a data model and ...
The US Food and Drug Administration (FDA) is working on ways to facilitate greater use of real-world data (RWD) to help understand the safety and efficacy of medications used during pregnancy and ...
Background The increasing global burden of long-term illnesses necessitates high-quality data to inform effective interventions, particularly in low-resource settings. Despite the critical role of ...
International regulators will increase cooperation for observational studies conducted in three key eras during the coronavirus pandemic. Building a strong infrastructure to monitor vaccine safety and ...
Clayton Irvine, PharmD, MBA, MS, explains that leveraging high-quality, real-world data; cross-institutional collaboration; standardized care pathways; advanced technologies; and integrated ...
Drug safety during pregnancy is an area of continued importance as substantial uncertainty persists regarding the safety of many medications, and the use of ...