The journey to approving a clinical drug is long and very expensive. Testing usually begins with an animal experiment that can take months or years. It will take several more years to prove the safety of the drug, move to human trials, and finally test the efficacy in a large group.
But that timeline goes beyond the pandemic.
There are no clinically approved drugs to treat the novel coronavirus that causes Covid-19. Prior to December, there was no known virus to test drugs, of course, spending years investigating. Therefore, doctors have two options. Either treatment or not treating the patient at all. Both present dangerous ethical challenges.
Rebecca Lee, Harvard Multi-Regional Clinical Trials Center The university states that drug use to treat Covid-19 should not be allowed. “Clinical trials have a reason,” she says. “Most drugs will eventually fail.” Clinical trials protect patients from the harm that can result from treatments, and mean that clinicians do not waste time on ineffective drugs. She argues that a pandemic is not a reason to skip these safeguards.
But others are more practical. Arthur Caplan, head of the medical ethics department at NYU Langone, says that it is ethical to use other health-approved drugs as treatment when doctors face suffering patients. You. He says that this happened with Ebola, swine flu, zika, and now coronavirus.
For example, some of the first coronavirus patients in China have been ly given the HIV treatment lopinavir-ritonavir and the rheumatoid arthritis drug Actemra. Now that the virus is widespread around the world, doctors are increasingly looking at treatment possibilities and addressing the difficult ethics of testing their effectiveness while making the safest choice for patients .
Controlled test-with warning
When choosing to use treatments, physicians should be as systematic as possible and carefully document the patient’s medical condition, dosage and timing of treatment, and patient condition at the time of treatment. “It’s not research, it’s not managed, but we want to make observations systematic,” says Kaplan.
A few weeks later, if 10-20 patients do not seem to cause active harm with this drug, scientists can quickly move to the first stages of clinical research, Caplan says.
Many of the current clinical trials of coronaviruses are based on their initial treatment. Early research on lopinavir-ritonavir was The drug is not effective, Because the initial study was small, researchers Investigate furtherThere are also ongoing trials on arthritis medication Actemra, Antimalarial drugs ChloroquineAnd Japanese flu medicine Fabipiravir
Although clinical trials usually take months to years to start, Li believes that current coronavirus testing sets a speed record. Because of the large number of coronavirus patients, study participants can be registered quickly and easily.
However, determining how (and if not) those participants should be treated is not so easy. “Most people believe that placebo is needed for a gold standard exam,” Li says. Strictly speaking, placebo is just a sugar pill so that scientists can determine if the treatment under study is actively helping people.
True placebo ethics does not work in pandemic situations. If the patient is suffering from a serious medical condition, doctors will use “standard care” as a placebo instead. “Since most new drugs are ineffective or harmful, randomization to placebo in addition to regular care will not make it clearly worse.” Public health emergencies
For Covid-19, standard care will support most. The lopinavir-ritonavir study tested drugs for giving oxygen, ventilation, and antibiotics to patients, and for pumping blood, renal function, and blood pressure as needed. Researchers can also perform “adaptation tests”. That is, test different drugs against each other or combine drugs to see if their effectiveness improves. This format allows for faster cessation of certain medications that may not be effective, and allows more patients to receive potentially effective treatments. However, when compared to another drug, as opposed to placebo alone, it may take longer to prove that the drug is effective.
The best clinical trials should also be double-blind. That is, neither the physician nor the patient knows whether they are taking the drug under test. Doctors cannot selectively treat patients who think they are ill. Patients also have less placebo effects because they know they have drugs. However, it can be difficult to achieve without prior planning. The World Health Organization (WHO) trial of coronavirus is not double-blind as an organization You need to balance rigor and speed
Ethical issues are even more troublesome when testing vaccine candidates. Drug treatment is already given to sick people, but vaccines are usually created from scratch and given to healthy people. Determining both safety and efficacy requires a huge number of research participants. Stanley Pearlman, a professor of microbiology and immunology at the University of Iowa, has approximately 10 cases Guillain-Barre syndrome Vaccinations per million people. Almost recovered, 25 have died From vaccines.
Access and harm
Patients are waiting for treatment to emerge as doctors and researchers struggle to balance rigor and speed.
In the United States, the most advanced clinical trials of coronavirus are related to the antiviral drug remdisivir. Unlike most drugs under study, remdecivir is not approved for treatment of health conditions, so patients can only access the drug If accepted for clinical trialStatistically, most drugs are not effective. “It’s more likely it won’t work than it works,” Kaplan says of Lemdecivir.
But hurry does not help the whole patient. “If you don’t do carefully controlled clinical trials, you’ll usually find that using placebo means you’re wasting time going back many years,” Perlman says. Kaplan agrees. If you don’t implement the right criteria, it will be difficult to determine if the drug is really impacting, and your trial will take longer.
“We need to remember that randomized clinical trials are rocks where high expectations are routinely neglected,” says London. He states that about 90% of new drugs did not pass the test, and half of these are insufficient for most advanced tests. “And all these are all cases where researchers and sponsors plan ahead, do specific research in animal experiments, and are ready for human testing.”
Despite working at phenomenal speed, it may take months instead of years to find a cure for Covid-19. Ethical and rigorous research takes time, but requires investment. Without clinical trials, London warns, patients may receive ineffective or harmful treatments, clinicians may waste time on pointless interventions, wasting money on valuable resources You.
If treatment is urgently needed even in a pandemic, a carefully designed trial is the best way to help the patient.
4 Comments