Gates Package — page 1007

Now, this is how it works in nonpandemic times. In the emergency that COVID was, it needed to happen much, much faster. The U.S. government and other funders put up the money for some of the Phase 3 trials--the most expensive step in the process, because it involves so many people--even before drug candidates had been approved. Scientists also put off studying facets of the drugs that weren't crucial in an emergency. It was akin to proving that a car will get you where you need to go without exploding halfway there, but being a little unsure about its gas mileage or how well the tires will handle snow. For COVID, there wasn't an agreement in advance on a standard protocol for doing trials and deciding what data to collect within or across countries. During COVID, a lot of time and money was wasted because multiple, poorly designed clinical trials tested the same products but didn't produce conclusive evidence either way. We need to standardize the approach to trials ahead of time, ensuring that they're well designed and set up to provide definitive evidence as fast as possible. One of the few trials that was done well was the RECOVERY trial in the U.K, which looked at a number of drugs, including dexamethasone: It was ready to go within six weeks and included 40,000 participants at 185 sites.16 Some new ideas may push the limits of what regulators are comfortable with. One is that, if you test positive, you could get an immediate text message giving you the chance to volunteer for a clinical trial that needs people with profiles like yours. Simply click "Enroll Me" and you'll start the process; if you're selected, you'll get access to treatment--either the one being studied or the best one already in use--and you'll be helping speed up the clinical trial. Another innovation I hope to see is putting regulatory submissions in the cloud and in a standard format, so it can be reviewed by all the regulatory groups without duplication.