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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…

By admin, ago
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…

By admin, ago
Systemic lupus erythematosus (SLE)

The Invisible Disease

“I got diagnosed in my early 20s”  “I wanted to so badly say, ‘You guys have no idea. I’m in chemotherapy. You’re a–holes.’ I locked myself away until I was confident and comfortable again,” (despite of sparked rumors of addiction.) “had to take a break from my career last year to deal with Read more…

By admin, ago

Damn, it is the data!

Artificial intelligence (AI), machine learning (ML), deep learning (DL), and natural language processing (NLP) are hard-to-avoid buzzwords at professional conferences, scientific journals, technological news, social media, and, of course, any vendor’s marketing pitch. Many enthusiasts have even made the splash in media that AI is going to revolutionize everything and Read more…

By admin, ago