Clinical Researcher

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.

This article highlights the urgent need to explore solutions that enhance the robustness and efficiency of cancer clinical trials and research programs as it delves into the role of the microgravity environment in advancing cancer research.