Can Clinical Trials Rise Faster Without Losing Their Flavor?

My good friend is just getting into baking sourdough bread. She is having a tough time with the time commitment, which may seem odd, since the actual time spent interacting with the dough is only around 30 minutes, spread over a couple of days. The lion’s share of the time is spent idling, waiting around for the dough to build protein networks and rise without going too far and deflating. Her time commitment is that even if she isn’t actively “working” the dough, she still has to be aware of what’s going on and is dependent on things largely out of her control. This echoes some parts of the clinical trials process.

The sourdough baking process includes prepping the starter, mixing, kneading, shaping, optional second shaping, and baking. Clinical trials have a similarly stepwise process:

• Preclinical research
• Phase 1: safety and dosage
• Phase 2: effectiveness
• Phase 3: confirmation in a larger population
• Regulatory approval
• Phase 4: long-term effectiveness and safety, occasional

Each of these phases requires approval, oversight, data cleaning and handling, and a lot of paperwork. Overall, it takes an average of 10-12 years for most drugs to go from concept to market, with around eight years spent in clinical trials.^[1,2] On April 29, 2026, the US FDA announced a pilot program, currently underway, for real-time clinical trials.^[2] The “real-time” part of this is that the clinical trial sites involved in this pilot program send data to the FDA as it comes in.^[2] The idea is that this will allow FDA reviewers to see safety signals and data in real time, streamlining the process and hopefully getting drugs to market more quickly.^[2]

One major stated goal is to reduce “dead time” between clinical trial phases when no clinical trial is underway.^[2] The director of the FDA states that up to 45% of that 10-12 year period is time when no clinical trial is actively collecting data, and that this pilot program is designed to punch down that time.^[2] This may not be as effective as the FDA hopes, however, as some of the “dead time” they are hoping to cut is actually spent ensuring data quality and proper safety oversight. Think of it like baking the sourdough. My friend doesn’t actually have a problem with the 30ish minutes spent measuring, mixing, and kneading dough, but instead has issues with the 24+ hours of rising time between steps. This rise time is what makes sourdough have its signature flavor and characteristics. If you add instant yeast to the dough, it will rise much faster, but it won’t really be sourdough anymore.

This pilot program may help in some cases where time is of the essence, such as with a new pandemic. In fact, the FDA director used a theoretical pandemic as one of the example cases for implementing real-time clinical trials, which is undermined because in response to the COVID-19 pandemic, vaccines were fast-tracked and approved in under a year.^[2,3] It is clear that regulatory hurdles can be overcome in times of need, but it is less clear that real-time clinical trials - or the future proposed AI approval process - are the best methods to speed this process up while retaining high-quality data and making sure patient safety is the primary focus. If real-time clinical trials can achieve faster results without sacrificing safety and quality, it would be a real benefit to patients waiting for investigational medications. Hopefully, we can find a way to bake a flavorful, well-risen loaf without too much frustrating wait time.

References

[1] US Food and Drug Administration. (28 April, 2026). FDA Announces Major Steps to Implement Real-Time Clinical Trials. https://www.fda.gov/news-events/press-announcements/fda-announces-major-steps-implement-real-time-clinical-trials

[2] Brown DG, Wobst HJ, Kapoor A, Kenna LA, Southall N. Clinical development times for innovative drugs. Nat Rev Drug Discov. 2022 Nov 1;21(11):793-4. https://doi.org/10.1038/d41573-021-00190-9

[3] Wherry EJ, Jaffee EM, Warren N, D'Souza G, Ribas A. How did we get a COVID-19 vaccine in less than 1 year?. Clinical Cancer Research. 2021 Apr 15;27(8):2136-8. https://doi.org/10.1158/1078-0432.CCR-21-0079