Why Are Clinical Trials So Complicated?

Derek Lowe · 1 May 2020

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About ninety per cent of drugs that enter clinical trials fail.

Their wordsEven under all the constraints and controls that I've been describing here, 90% of our drugs fail in the clinic: can you imagine the failure rate if we tried to go faster and noisier?

Also said by Ruxandra Teslo

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Derek Lowe did not write this page.

Every claim below was made in this piece, quoted word for word and numbered in the order the piece makes them, so you can read it there rather than take our word for it. The sentence above each quote is our reading of the claim, not their wording. Each quote was checked against a stored copy of the page at build time; where the two differ, the quote is the fact.

Our reading
Standardised manufacturing and documentation cannot be skipped when a drug is given to human beings, because the noise they remove is the noise that would otherwise swallow the answer.

Their wordsYou cannot wing it when you're giving a drug to human beings.
Our reading
About ninety per cent of drugs that enter clinical trials fail.

Their wordsEven under all the constraints and controls that I've been describing here, 90% of our drugs fail in the clinic: can you imagine the failure rate if we tried to go faster and noisier?
Our reading
The bureaucracy around clinical trials is Chesterton's Fence: it was built on the harm done by sloppier trials and should not be pulled down without knowing why it went up.

Their wordsThe procedures that have grown up around drug development are a sort of Chesterton's Fence: we shouldn't pull them down without considering the reasons why they were put up.

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