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Monday, March 30, 2020

The race to develop coronavirus treatments pushes the ethics of clinical trials

Olivia Goldhill
Originally posted 28 March 20

Here is an excerpt:

But others are more pragmatic. Arthur Caplan, director of NYU Langone’s Division of Medical Ethics says that when doctors are faced with suffering patients, it’s ethical for them to use drugs that have been approved for other health conditions as treatments. This happened with Ebola, swine flu, Zika, and now coronavirus, he says.

Some of the first coronavirus patients in China, for example, were experimentally given the HIV treatment lopinavir–ritonavir and the rheumatoid arthritis drug Actemra. Now, as the virus continues its rampage around the globe, doctors are eyeballing an increasing number of treatment possibilities—and dealing with the challenging ethics of testing their efficacy while making the safest choices for their patients.

Controlled trials—with caveats

When choosing to use an experimental treatment, doctors have to be as methodical as possible—taking careful note of how sick patients are when given treatment, the dose and timing of medication, and how they fared. “It’s not a study, not controlled, but you want observations to be systematic,” says Caplan.

If, after a couple of weeks and 10 or 20 patients the drug doesn’t seem to cause active harm, Caplan says scientists can quickly move to the first stage of clinical research.

Many of the current coronavirus clinical trials are based on those early experimental treatments. Early research on lopinavir–ritonavir suggests that the drug is not effective, though as the first study was small, researchers plan to investigate further. There are also ongoing trials into arthritis medication Actemra,  antimalarial chloroquine, and Japanese flu drug favipiravir.

While clinical trials typically take months to years to get started, Li believes the current coronavirus trials will set records for speed: “I don’t think they could go any faster,” she says. It helps that there are a lot of coronavirus patients, so it’s easy to quickly enroll study participants.

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