by Ruanne Barnabas, Associate Professor, UW Global Health
“I’m glad the study is randomized,” my father said over WhatsApp video from his assisted living facility thousands of miles away in Cape Town, where he has been under lockdown for 32 days in a tiny apartment with my mother. “Yes, dad,” I answered without the surly teenage overtones of knowing better. We both understood that despite the real risks he and my mother face during the COVID-19 pandemic, and the craziness of my home schooling two children while working at home in Seattle, real science – the kind that uses strict scientific and unbiased methodologies – is urgently needed to answer questions that could potentially save lives.
Since the global pandemic began, the media has repeatedly put a spotlight on hydroxychloroquine as a potential drug to fight COVID-19, lurching from one topic to the next. Last week, as I gave a public lecture, I was asked “is it ethical to conduct a clinical trial with a placebo arm during the coronavirus pandemic?” This week I faced questions about “whether the FDA drug safety communication means that participants will not want to enroll in hydroxychloroquine COVID-19 clinical trials?”
The FDA notice clearly stipulated that clinical trials for hydroxychloroquine as prevention and treatment should proceed. As a lead researcher for a hydroxychloroquine for COVID-19 post-exposure prophylaxis study, we are redoubling our efforts to conduct safe, rigorous studies to questions that urgently need evidence despite the waxing and waning popularity of hydroxychloroquine. We are staying true to rigorous testing methods to learn about what works.
I think about Gregor Mendel – known as the "father of modern genetics" – patiently growing his pea plants, ensuring that he knew which pea had been planted where and carefully recording the results over generations, to discover the fundamental laws of genetic inheritance. This kind of rigor, patience, and expertise needed to conduct sound clinical trials is not made for catchy headlines or soundbites.
For hydroxychloroquine, data are encouraging – in the laboratory hydroxychloroquine stops entry of the virus into cells and inhibits viral replication – we don’t know yet whether it can prevent or treat early COVID-19 in people. The best way for us to learn this is through clinical trials, which are conducted with participant safety as paramount. Independent data and safety monitoring committees closely follow study results to ensure that we learn about drug efficacy and safety as quickly as possible. Clinical trials provide the best evidence to save lives – we need them more than ever during this pandemic. And my father agrees.