Clinical Trials Are in Crisis—And No One Wants to Talk About It
By Jenna Levenson, PhD, RN, MS
There is an elephant in the biotech boardroom and it is wearing a lab coat.
As NIH budgets drastically shrink, venture capital becomes more selective, and pharma tightens R&D belts, the clinical trial ecosystem is being slowly starved.
Yet many in biotech are still posting celebratory press releases while internally downsizing trial operations and delaying critical studies.
Now What? Fewer trials are getting off the ground First-in-human studies are being deprioritized Patients with rare and urgent diseases are waiting even longer.
This is not just about macroeconomics. It is about how clinical trials have failed to defend their value at the C-suite level. Clinical trials have become too expensive, too slow, and too disconnected from ROI.
Here Is What You Are Not Seeing
Mid-stage trials are the first to go with Biotechs shelving Phase 2s until market conditions improve.
CROs are consolidating which leads to higher prices and lower flexibility. Some niche vendors are thriving while others struggle with being replaced by bloated bureaucracies.
Innovation in protocol design has stalled as decentralized trials do not always translate to faster and cheaper execution.
As a Result - Talented clinical teams are being laid off while nonclinical departments grow.
How Do Biotechs Save Their Programs & Investigators Make Smarter Decisions?
If you are still trying to run your 2022 playbook in 2025, you are already behind. Here is the new operating reality:
Simplify protocols—complexity is a cost multiplier.
Use AI judiciously—not as a buzzword, but as a true enabler of efficiency.
Make the case to leadership that trials aren't just a spend—they are the strategy.
Get creative with funding—federal grants, non-dilutive capital, and shared-risk models must be part of your playbook.
Co-design with patients—not for PR, but because irrelevant endpoints won’t cut it anymore.
This is Not Just a Funding Problem—It is a Vision Problem
We need clinical leaders to speak louder. We need biotechs to stop treating trials like cost centers. And we need investors to stop funding “AI-in-biotech” startups that cannot define what a protocol deviation actually is.
If we want to avoid a full-blown research recession, the time to act is now.
Have you felt the pressure to scale back trials? Are you seeing trial design stagnate? Let’s Talk.