FDA_RWE_RWD

FAQs about the FDA Guidance on the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products

Analyzing real-world data (RWD)1 to generate real-world evidence (RWE)2 is an emerging trend in the healthcare community. RWE is routinely used to evaluate a treatment’s real-world effectiveness, safety, and economic value, but it has also been increasingly leveraged in clinical trials. To promote the progression this field, FDA has published Read more…

AI and LLM for RWE

Leveraging Large Language Models like ChatGPT for Real-World Evidence Generation

Large Language Models (LLMs), including ChatGPT, have gained significant traction since late 2022, sparking debates about whether they’re mere hype or a genuine revolution. However, their undeniable utility spans personal and business activities, including but not limited to proofreading and editing, language translation, coding and debugging, and content creation. At Read more…