Remix.run Logo
mft_ 7 months ago

I'm sorry, but for industry-sponsored trials your figures are off by up to an order of magnitude, despite the numbers in the (18 year old) reference.

Phase I: a small biotech I know of in oncology has phase I costs in the order of $500,000 per patient; this is a higher-end cost, due to their sites being in the US (more expensive than Europe) and because as a small biotech they're had to outsource virtually every aspect of running the trial. In big pharma, per-patient costs were more like $70-100k per patient, but this was just the pure money paid patient (to the site, and external costs like drug supply and shipping) and ignored the cost of laboratory, clinical, operations, and data management work that was being done in house. All told, it would typically be hard to get even a phase I study completed for less than 10x your estimate, and this is before you consider any additional recruitment needed between dose escalation and phase III.

Phase III: again it depends on many factors, but in big pharma a trial cost of $100-200k per patient was again not unreasonable, and typical phase III trials where you're comparing to a meaningful established medicine are larger than 100-200 patients. A biotech I know of is unable to run a phase III for a promising drug without finding a partner to support the majority of the cost (which is >100m EUR in oncology) and they're not wasting money.

---

A less anecdotal approach is to consider the total R&D costs of companies across a given timescale, and divide by the number of successes. It's a pretty old reference too, but Matthew Herper did this in 2013. [0] Yes, there were some outliers with low costs, but you'd have to understand the details for context. The typical costs were in the hunderes of millions to billions per successful drug.

[0] https://www.forbes.com/sites/matthewherper/2013/08/11/the-co...