News By: Gary Cramer

This column shares feedback received recently on careers in the medical device research field and the state of the sector from Stacey Banks, MS, MBA, CCRC, ACRP-MDP, Director of the Clinical Research Support Office for Inova Health System in Virginia, and Danyel Carr, MS, CCRA, Senior Director of Clinical Affairs for Argon Medical in Texas.

Although the U.S. Food and Drug Administration’s oversight of medical devices first came under the Food, Drug, and Cosmetic Act in 1938, the regulation of medical devices started in 1976. The pathways for medical devices and drugs to reach the market are quite different, as summarized in this article.

Real-world evidence and externally controlled trials play increasingly critical roles in achieving marketing authorizations for drugs undergoing research and development, but sponsors must navigate a diverse body of regulatory guidance documents to prepare for successful regulatory engagements.

This column provides an overview of the Health Insurance Portability and Accountability Act's (HIPAA’s) key data privacy and security measures, along with some steps organizations engaged in clinical research can take to ensure they are in compliance.

Informed consent, a cornerstone of ethical research involving human subjects, presents a unique challenge in emergency medical cases. However, utilizing exceptions to obtaining informed consent in emergency research offers significant benefits.