Adam Kroetsch

@otis_reid Also, a CRO probably would need to vertically integrate or partner closely with sites to drive down costs. That's hard and expensive (some are trying, though!).

@otis_reid It's a good question! Risk aversion is part of it: the safest CRO will get picked over the cheapest CRO. But there's a few other factors hold back competition: The industry is consolidated and entry is hard. Switching costs are high.

Good post by @kroetscha on rapidly rising clinical trial costs (link in next post) but I still am confused why competitive pressures among CROs don’t drive costs down more / encourage reforms like electronic record keeping. Risk aversion doesn’t seem like enough to explain it

First post! The case for sharing clinical trial data, by me. Sharing individual patient data from clinical trials can make a lot of further research possible – including better meta-analyses and learning how to run trials more efficiently in the future. clinicaltrialsabundance.blog/p/the-case-for…

NEW BLOG! @RuxandraTeslo, @kroetscha, @vientsek, @NeuroStats, and I have started a joint blog on Clinical Trials Abundance! We'll aim to publish weekly thoughts, commentary and ideas on how to make clinical trials more efficient & abundant. Subscribe: clinicaltrialsabundance.blog

@doc_BLocke @varma_ashwin97 @calebwatney Agree. What looks like flexibility in the regulations can turn into ambiguity on the ground. We would benefit from more certainty - like safe harbors - so sponsors know what “good enough” looks like.

@varma_ashwin97 @calebwatney Not the aggressiveness of the regulators… the ambiguity. Sponsors are optimizing around uncertainty in how the FDA will ultimately appraise. If things were more certain- even if more aggressive- the system could be a lot more efficient.

25-40% of clinical trial costs come from an excessive quality-check process that the FDA itself has recommended against for over a decade. Great piece from a former FDA official on why the whole system is stuck in a "too big to fail" loop. learninghealthadam.substack.com/p/why-clinical…

You can learn more about the initiative and subscribe to updates here: learninghealthadam.substack.com/p/introducing-…

High clinical trial costs limit what we can study and limit the availability of new treatments for patients. To make trials cheaper and faster, we need systemic reforms to the policy, incentives, and infrastructure that underlie our clinical trials system.

I'm very excited to announce a new research project: the Clinical Trials Efficiency Project. Through this work, funded by Coefficient Giving, we will be advancing systemic reforms to reduce clinical trial costs.

The post is here: learninghealthadam.substack.com/p/the-badness-…

I wrote about the regulatory cascade for the @rootsofprogress fellowship. Thanks to @jasoncrawford for some crucial early input and insight, along with @MikeRiggs and @econpragmatist for feedback! Curious what folks like @ATabarrok @tylercowen @slatestarcodex think about this!

So what do we do? ✔️ Clearer, more specific rules (safe harbors, measurable standards) ✔️ Proportionate penalties (to avoid overcompliance) ✔️ Strong, competent bureaucrats (yes, really) to keep cascades in check

Why do rules and regulations so often mushroom into binders of procedures, audits, and checklists—far beyond what government actually requires? I call this the regulatory cascade. 🧵

The danger isn’t just inefficiency. A culture of zero tolerance for “badness” can distort decision-making and stifle innovation. More process ≠ more safety. Sometimes it just means more clutter.

Key insight: the cascade doesn’t only come from government. Private actors—firms, insurers, auditors, standards bodies—become rulemakers too. And their rules can be stricter, costlier, and harder to escape.

Each layer adds more rules than the last. The result: an entrenched bureaucracy of risk aversion and procedural clutter. Once in place, almost impossible to unwind. This is the regulatory cascade.

➡️ Courts add factors and case law. ➡️ Agencies issue guidance, FAQs, webinars. ➡️ Companies hire Chief Badness Officers, write internal policies. ➡️ Insurers, auditors, consultants pile on. ➡️ Vendors and partners pass rules down the chain.

Imagine Congress passed just one law: “Don’t be bad.” They empower the Badness Police to enforce it. One page of rules, no more. Sounds simple… until the cascade begins.

Join us tomorrow for the Duke-FDA meeting—Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials! #ResearchInPregnancy Register here. healthpolicy.duke.edu/events/scienti…

Today, at 12:00pm EST, @DukeMargolis will be hosting a discussion on the development of #COVID #Vaccine with guests @ScottGottliebMD Peter Marks, Peggy Hamburg @califf001 and others... Register here: healthpolicy.duke.edu/events/safe-an…