"90% of drugs that pass animal tests fail in humans."
It's one of the most repeated claims in the debate on animal research. A new industry survey shows why the claim does not hold up. The IQ Consortium asked 45 pharmaceutical companies how they use new approach methodologies (NAMs). The answer: almost all of them, all the time.
🔹 98% use in vitro models
🔹 84% use computational models
🔹 73% use NAMs to de-risk drug targets
🔹 58% use them to judge efficacy when picking lead candidates
🔹 84% use computational models
🔹 73% use NAMs to de-risk drug targets
🔹 58% use them to judge efficacy when picking lead candidates
This means that the drugs that enter clinical trials have already been selected largely using cell-based and computer methods. That is especially true of decisions on whether a drug will work, and lack of efficacy is the biggest single reason drugs fail in the clinic.
Clinical attrition reflects how hard human biology is to predict across the whole preclinical toolkit, not the failure of any one method. The 90% figure also ignores the drugs that animal studies stopped before they ever reached a patient.
Industry clearly wants to use NAMs more. The barriers it reports are scientific and regulatory, not cultural, or that the research community is to ‘old fashioned’ and conservative. 84% of companies are uncertain whether regulators will accept NAM data, and 80% are unsure how well NAMs predict human outcomes. The authors put it well: regulatory acceptance is "at its core, an evidence challenge."
That's the right way to frame the transition to NAMs. It should be driven by evidence, so patient safety is never compromised.
From Kirk Leech, EARA Executive Director