Miruna Sasu, PhD, MBA, president and CEO of COTA Healthcare, discusses 3 ways in which the FDA can provide, and has provided, assistance on the capture of real-word data (RWD) in electronic medical records.
Miruna Sasu, PhD, MBA, president and CEO of COTA Healthcare, discusses 3 ways in which the FDA can provide, and has provided, assistance on the capture of real-word data (RWD) in electronic medical records.
Transcript
Can you go into more detail on what else the FDA needs to do to facilitate use of real-world data?
So, they've done a lot. I used to work for the federal government, so I’m a big believer that they need to see industry innovate and then respond to that. And they've done a lot so far. I think one thing I really respect that they did was ensuring the enablement of electronic medical records in general—that was a big deal.
And second was the guidance of how the real-world data should be used for clinical trial regulatory approvals. I think that was a big deal as well—just issuing that guidance to say, “We’re looking and we’re doing this work, and we are open to receiving external controls and databases,” and so on.
The third thing that I think that they can do and should do goes along with the electronic medical records piece. Now that we're going into using electronic medical records for clinical trials and augmenting clinical trials, to ease the burden on patients, to ease the burden on providers, one area of expansion of that would be to capture the data in a way such that it looks more like a clinical trial. And that is at the provider level. Statisticians have a saying, “Garbage in, garbage out.” So, if the electronic medical record, the input into that, is really, really messy, you can only do so much to clean it up and place it in a database for use. But if, at the source, when entering the data, you were very, very clean about how you entered it—and it was processed in an almost clinical trial–like way—then what you can segment out of that data is a lot cleaner and better.
So, I would argue that the FDA should help us figure out a way and help providers figure out a way to work on their electronic medical record data capture, so that it looks a little closer to clinical trial data.
Study Finds ASCT Similarly Safe, Effective in Older and Younger Patients With Multiple Myeloma
November 30th 2023A real-world study suggests high-dose chemotherapy followed by autologous stem cell transplantation (ASCT) is feasible for appropriately selected elderly patients, with similar results seen in older and younger patients.
Read More
Emily Goldberg Shares Insights as a Genetic Counselor for Breast Cancer Risk Screening
October 30th 2023On this episode of Managed Care Cast, Emily Goldberg, MS, CGC, a genetic counselor at JScreen, breaks down how genetic screening for breast cancer works and why it is so important to increase awareness and education around these screening tools available to patients who may be at risk for cancer.
Listen
What We’re Reading: ChatGPT in Health Care; Menthol Ban Meeting; Health System Cyberattack Impact
November 30th 2023ChatGPT is changing health care while also raising questions about artificial intelligence's promises and limitations; 24 Biden officials met with the National Organization of Black Law Enforcement Executives to discuss the FDA’s proposal to ban menthol cigarettes; a recent hospital cyberattack shows how the vulnerability of health care systems can put patients at risk.
Read More
7-Day Dosing of Azacytidine Shows Benefit for Females With High-Risk MDS Not Seen in Males
November 30th 2023Investigators from several medical centers in Japan were surprised to find that women with myelodysplastic syndrome (MDS) had a survival advantage from a 7-day dosing schedule, but that benefit compared with a reduced schedule was not seen in men.
Read More