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Why are clinical trials so expensive?

by ChristianKl1 min read5th Feb 20215 comments

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While I know that clinical trials such as the trials for vaccines cost hundreds of millions of dollar, I have a hard time understanding why they are so expensive. I read about clinical trials for a vaccine costing 10,000/study participant. Given that the trials are so expensive they seem to be the bottleneck for medical progress. If we find a way to run them cheaper that would massively accelerate medical progress.

What resources do a good job at documenting the costs of clinical trials and how those high costs come about?

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Not sure of all the costs, but my wife and daughter are in one of the trials, and they're each getting paid $1,600 on completion. They also have regular testing visits (not sure how often, though).  Depending on your assumption of how many trials are successful, that might get you a decent part of the way to $10,000 per participant in a successful trial.

A lot of commonly sited drug trial prices are risk adjusted, meaning they take into account the high probability of failure, and are thus many multiples higher than the cost of an actual single trial. 

https://pubmed.ncbi.nlm.nih.gov/26908540/#:~:text=A%20Phase%202%20study%20cost,pain%20and%20anesthesia)%20on%20average. 

"A Phase 2 study cost from US$7.0 million (cardiovascular) to US$19.6 million (hematology), whereas a Phase 3 study cost ranged from US$11.5 million (dermatology) to US$52.9 (pain and anesthesia) on average."

Thus, in reality, clinical trials are not THAT expensive, but they have a high risk of failure. 

What may have made vaccine trials so expensive was the massive number of participants needed to be administered the vaccine and followed to get good data. 43,000 for Pfizer. 

You need to sponsor whole trial centres, pay for the expensive time of doctors, pay for data management and auditing and more. I read a good paper with a breakdown once but was unable to find it for you. There are likely more similar papers. 

3 comments, sorted by Highlighting new comments since Today at 3:35 PM

My (limited) understanding is that the high costs are, in many cases, largely a matter of overhead and regulatory compliance, not technical or technological.

If that's the case, understanding the costs could allow reform of the regulations to reduce the costs and make clinical trials cheaper.

Do you know how much it costs to keep the lights on at a medical research lab? If you think about that then $10K per head is probably cheap.