| 摘要 |
This invention provides a device, and method and system for its use, for monitoring participants in clinical trials so that participant self-reporting, which is known to be notoriously inaccurate, can be minimized or eliminated. In preferred embodiments, the device is self-contained and self-powered, resides on or in a body cavity of the participant, collects data monitoring medically relevant aspects of the participant's behavior and of the local device environment, and stores data in a memory on-board the device. An accompanying external station reads stored data and prepares it for use. Devices may include electrically-active sensors and non-electrical active sampling sensors. A preferred embodiment of the device is in clinical trials of microbicides inhibiting transmission of the HIV virus. |
