Predicting the outcome of clinical trials by computer?

Clinical trials are very expensive, time consuming and frequently yield inconclusive results.

An article in Wired magazine described a computer simulation model that can predict the results of drug trials in humans, without actually giving a single patient a pill.

The model is called Archimedes, and is based at the San Francisco company of the same name. Its creator, David Eddy, spent two decades programming information about anatomy, physiology, disease, risk factors and their response to different drugs. The article explains how Archimedes was able to almost exactly predict the true results of the CARDS trial (examining the effects of statin therapy on cardiovascular outcomes in diabetic patients) ahead of unblinding of that study.

Whilst the underlying algorithms and assumptions of Archimedes are a trade secret, do you think it gives us a glimpse into the future of clinical trials? Where studies of drug efficacy will be simulated on hundreds of thousands of patients? There’s also evidence that the adverse effects of drugs (for example hepatotoxicity) can also be predicted with reasonable accuracy. This is achieved by comparing the molecular structure of the drug in question with millions of others that have a known side effect profile.

Personally, I think these developments are fascinating, but I think the era of the large-scale clinical trial will be here for a while yet. Whether big pharma can leverage these types of simulations to screen for likely efficacious molecules with few adverse effects on human physiology remains to be seen.

What do you think? Let me know in the comments below.