“Real World Evidence” on Effectiveness of Experimental Drugs Can Be Extracted From Electronic Health Records

(p. A7) . . . analysis of compassionate-use data, about the experimental drug remdesivir from Gilead Sciences Inc. published in the New England Journal of Medicine, came under criticism. Scientists pointed out that the Covid-19 patients received the drug in centers around the world where care may have differed, data on some patients was incomplete and there was no comparison group.

That study’s first author, Jonathan Grein, of Cedars-Sinai Medical Center in Los Angeles, said given how little is known about the coronavirus and how to treat it, “I think at this point any information is potentially helpful.” He said the study, funded by Gilead Sciences, noted the findings were limited and preliminary. “It is a starting point, an opportunity to aggregate our initial experiences,” he said.

. . .

The FDA . . . has worked closely with companies trying to extract “real world evidence” about patients’ experiences with new or experimental drugs from sources such as electronic health records.

For the full story, see:

Amy Dockser Marcus. “Hundreds Get Plasma in National Study.” The Wall Street Journal (Wednesday, April 22, 2020): A7.

(Note: ellipses added.)

(Note: the online version of the story has the date April 21, 2020, and has the title “Hundreds Receive Plasma From Recovered Coronavirus Patients in National Study.”)

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