Real World Data for Emergency Use Approval of COVID-19 Therapies         
[Thursday, April 23, 2020]

With more than 850,000 confirmed cases and more than 47,000 death from COVID-19 in the US alone, the pandemic has overwhelmed practically all aspects of our healthcare and life. But there is a silver lining. Although there is yet no approved therapy, the patients infected with the coronavirus are being managed by their physicians and healthcare workers using a myriad of available drugs and are showing various degrees of responses. More than 95% of the confirmed infected patients survive the disease, but as yet there are no recommendations from the FDA or CDC as to what practices or drugs work better once infected leading to widespread misinformation about practically all aspects of the disease and its management. These are an ideal condition for a detailed real world data analysis of the practices and treatments used by the patients to identify trends in disease progression and management using available therapies. The demographic distribution of the patients and the speed of the spread of the infection offers an opportunity to collect detailed information on the patients and how they deal with the infection. This data can be used to build treatment guidelines tailored to different patient populations. This can also be used to build a catalog of the various ways patients are managing their disease and evaluate if any treatment regimen is better than others and, theoretically, even used to support emergency use authorizations for previously approved drugs for use in COVID-19. Getting an emergency use authorization requires preliminary clinical evidence that does not necessarily need to come from clinical trials; it can come from the real world evidence as well. There are about 150 clinical trials currently ongoing in the US but it could take months and longer for any effective treatment to emerge from the ongoing trials. However, real world data may offer some readily available near-term answers. Now only if the medical records can be accessed easily. In the pandemic, that is already happening. Patients are eager to share their experiences to help their families and friends from the pandemic. About time someone take them up for it.