Adverse effects are one of many reasons why drug development is so expensive, and one reason why this week’s BioGPS Featured article is so interesting.
The drug development process typically looks something like this:
Not only does it take a long time to develop a drug, the risk of failure is quite high and each failure is costly. According to a study last year in Nature Biotechnology, about 10% of all indication development paths make it through phase I clinical trials (looking at safety) successfully. Because of the small numbers in Phase I, it’s hard to determine if observed side effects are general or patient-specific.
This week’s featured article aims to use multi-omics to “estimate the systemic impact (side/adverse events) of (novel) therapeutic targets.” The researchers focus on rheumatoid arthritis which is a very complex disease and also accounts for 20% of the Top 10 clinical trial failures in 2013 as ranked by the size of the writedowns associated with the trial outcome.