The need for any kind of treatment to help stem the coronavirus outbreak is acute as cases and hospitalizations continue to mount. But there’s a strong need to balance urgency and evidence.
President Donald Trump’s cheerleading of chloroquine and its derivative hydroxychloroquine — older malaria drugs with limited evidence of efficacy in Covid-19 — is arguably dangerous. As he touts the drugs in press conferences, people are reportedly poisoning themselves via self-administration and hoarding it to create hazardous shortages, making the prudent use and evaluation of it as a treatment more difficult. That said, sitting on medicines while they make their way through a lengthy trial and regulatory process is also a mistake. The worst of the pandemic will arrive soon in parts of the U.S. With vaccines and novel therapeutics far away, inaction has a high human cost.
A potential solution is innovation, not just in cleverly repurposing old drugs, but in how we test whether they work. While cautious use of existing treatments for the sickest patients should continue, simultaneously running a wide variety of ambitious clinical trials will help get more drugs to more patients and could help rapidly confirm what works best, the sooner we can generate data that helps doctors give the right drugs to the right people, the better.
Excitement about chloroquine and hydroxychloroquine isn’t entirely baseless. Other countries have seen enough promise to include it in treatment guidelines. While a widely covered positive French trial that combined hydroxychloroquine with an antibiotic was small and flawed, the results warrant further study. The fact that these are cheap generics with a long history of use could make them especially helpful. On the other hand, this group of medicines can have side effects, and an abstract for a Chinese trial detailed in a recent research note by Evercore ISI analyst Umer Raffat describes poor results for hydroxychloroquine in mild patients. We know far too little to put too many eggs in any one basket.
Traditional trials are rigorously designed, generally run without deviation from the initial plan, and are only analyzed once the data is ready according to a pre-specified plan. Such trials are standard for a reason; it’s a battle-tested process and statistically reliable. But it can be slow and inflexible, which calls for new tools such as so-called adaptive trials that evolve based on incoming data. These more recently developed tests let researchers use data from their ongoing trials to count out treatments or doses that aren’t working and add new arms based on emerging evidence. They can also allocate more patients to regimens that are looking good, and focus recruiting on patients most likely to benefit.
Well-run adaptive trials can be smaller, faster, and more ethical, all features that make them well suited to this moment. And they are growing in popularity. Some researchers and parts of the drug industry have been slow to change, however. Now is the time to push the envelope.
The World Health Organization is taking a positive step with a large and rapidly designed adaptive trial testing multiple coronavirus approaches, including chloroquine and hydroxychloroquine, Gilead Sciences Inc.’s remdesivir and an HIV drug. The worthy priority of the trial is simplicity; it aims to collect data from as many places as possible, without strict requirements that overwhelm health workers.
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It’s a crucial effort and a good blueprint. It needs to be supplemented by further similar studies in the U.S. and around the world to broaden access and answer emerging questions. The WHO trial doesn’t include every promising treatment, and the HIV drug it is testing has already failed to show a benefit in some small trials. The stage of infection, symptoms, age, and pre-existing conditions will likely create variation in how people respond to treatments and what they need, further underscoring the need for a wide variety of flexible designs.
It’d be a good thing if the president used his office to support responsible efforts to speed development. But perhaps his cheering section should be behind the scenes, rather than behind the podium. – Bloomberg
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