Hey friends! https://abs.twimg.com/emoji/v2/... draggable="false" alt="👋🏼" title="Waving hand (medium light skin tone)" aria-label="Emoji: Waving hand (medium light skin tone)"> I wrote my first newspaper article.

In this perspective piece, I talk about the importance of randomized clinical trials even in the most challenging settings (like pandemics!). And I outline smart ways to accelerate this process.

1/ https://www.washingtonpost.com/outlook/coronavirus-hydroxychloroquine-trials-research/2020/04/10/fa003ada-7a7a-11ea-a130-df573469f094_story.html">https://www.washingtonpost.com/outlook/c...

2/ Many are anxious to use investigational drugs to treat covid19 patients, but we don’t yet know if any of these work. We tend to overestimate the promise of drugs (it works in the lab!) and underestimate the risks (it can cause fatal arrhythmia). https://www.acc.org/latest-in-cardiology/articles/2020/03/27/14/00/ventricular-arrhythmia-risk-due-to-hydroxychloroquine-azithromycin-treatment-for-covid-19">https://www.acc.org/latest-in...

3/ There’s a reason why we use randomized clinical trials even for Ebola or late-stage cancers. Many drugs don’t work at all for severe cases, and those that do are often only mildly or moderately effective. https://www.nejm.org/doi/full/10.1056/NEJMoa1604330">https://www.nejm.org/doi/full/...

4/ Outside of the rare miracle cure, randomized trials are the only reliable way to sort out whether patients do better because of the drug or whether they would have recovered on their own.

5/ So how do we accelerate clinical trials to match the intense pace of pandemics? Our key recommendation is to run flexible, multi-site trials with new locations added over time. This is described in our recent article in @NEJM. https://www.nejm.org/doi/full/10.1056/NEJMsb1905390">https://www.nejm.org/doi/full/...

6/ This flexible structure, which we call a core protocol, speeds enrollment. And it is particularly valuable here because it makes the trial robust to the unpredictability of outbreaks. Even if an outbreak ends in one spot, the trial can continue in a new hotspot.

7/ Hundreds of trials are underway now, including a few large ones using this core protocol approach (WHO’s Solidarity trial, and NIAID’s adaptive trial). The goal is to produce rapid and reliable evidence on the performance of these drugs.

8/8 Until then, we must protect the safety of patients now and in the future by restricting the use of these drugs to clinical trials and other limited settings. This is the evidence-based approach taken by the EMA. FDA take note! https://www.ema.europa.eu/en/news/covid-19-chloroquine-hydroxychloroquine-only-be-used-clinical-trials-emergency-use-programmes">https://www.ema.europa.eu/en/news/c...