data-integrity
3 stories tagged "data-integrity"
Investigations
The FDA Will Now Accept Real-World Evidence for Devices Without the Patient Records Behind It
The curation that turns raw medical charts into "regulatory-grade" evidence happens inside private vendors like Roche-owned Flatiron Health. The public record does not show who, if anyone, independently audits it.
InvestigationsPennsylvania Announced Two Measles Deaths Its County Coroner Never Recorded
Pennsylvania classified two Lancaster County fatalities as measles-associated, including a newborn the county coroner says he certified as dying from a ruptured spleen and blood loss. The CDC won't add either to the national count until the record shows measles caused or contributed to the deaths.
InvestigationsNEJM Retracted the Study That Approved Amgen's Vasculitis Drug. It Had Never Done That in 200 Years.
The FDA says the drug's superiority result came from re-scoring nine patients after the trial was unblinded. It is still on U.S. shelves while Amgen fights the withdrawal.