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  "path": "/t/thinking-clearly-about-association-studies-risk-factors-and-causal-salad-included/28679?page=2#post_28",
  "publishedAt": "2026-04-06T06:51:13.000Z",
  "site": "https://discourse.datamethods.org",
  "textContent": "Thank you for your questions. I selected this drug as an example randomly - one that was approved on this basis. Agree that withdrawing the drug for safety concerns is inconsistent with the context of terminal disease. I’m not familiar with the indication or what other drugs may have been approved after that approval. It was just an example how observational studies can be acceptable in some cases but there are many others. (Worth noting that HIV advocates pushed the FDA to consider conditional approvals based on surrogate endpoints)\n\nAI Query response: Between 2002 and 2021, the FDA granted 116 accelerated approvals for oncology indications based on single-arm trials. **Endpoints** : Roughly **98%** of these approvals rely on **Response Rate (RR)** or **Duration of Response (DOR)** as surrogate endpoints.\n\n  * **Line of Therapy** : Most (approx. **74%**) are for **second-line or later** treatments for metastatic disease.\n\n  * **Confirmatory Trials** : Manufacturers are required to conduct post-approval randomized controlled trials (RCTs) to verify clinical benefit (often using overall survival or progression-free survival).\n\n  * **Success Rate** : About **38–43%** of these indications eventually fulfill their requirement to verify clinical benefit and convert to traditional approval.\n\n\n",
  "title": "Thinking Clearly about Association Studies (Risk Factors and Causal Salad included)"
}