Clinical Researcher

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.

Why is marketing and advertising often overlooked in clinical research? Patient recruitment and retention in clinical research frequently encounter obstacles, resulting in delays and increased expenses. While marketing and advertising have the potential to address these issues, they are frequently underutilized in clinical trials due to ethical concerns, regulatory constraints, and misconceptions about their role.