Able Quote by Francis Collins
“When a drug comes out [that's broadly prescribed] there are going to start to be a lot of people on it [in a million person cohort] and you might get therefore an early signal of something unexpected that hadn't come through in the clinical trials. And I'm sure [drug companies] would love it if, in fact, FDA, recognizing that, would say, OK, maybe you don't have to do your trial with 30,000 people because we're going to find out shortly after registration because we'll have a lot of people taking the drug and we'll be able to see what happened using PMI.”
About This Quote
Source Speech: Interview on pharmacovigilance, 2015
Large-scale post‑marketing data can reveal rare adverse effects missed in trials.
In simple terms: Real‑world data catches hidden drug risks.
Use post‑approval monitoring to ensure safety.
Themes
Mood
Type
When to use this quote
- new drug launch
- clinical trial design
- health policy
- patient safety
Key Concepts
Questions to Reflect On
- How can we improve data collection after drug approval?
- What safeguards protect patients before signals emerge?
Limited by reporting bias and data quality.