Drug discovery is known to be a long, expensive process. On average it can take decades and cost more than $1 billion to bring a drug to market. Yet, despite the large investment in time and money, less than 10 percent of drugs succeed in obtaining U.S. Food and Drug Administration (FDA) approval. Two factors are driving significant changes to the drug discovery and approval process—the sharp drop in the cost of high-throughput genomic sequencing and the growing recognition that molecularly targeting therapies to a smaller subset of patients increases effectiveness. Randomized controlled trials (RCTs) have been the gold standard for the design of clinical trials needed to obtain drug approval. But in the era of personalized medicine RCTs may not be the best fit. RCTs require enrolling hundreds or often thousands of patient participants. After the fact, post-hoc analysis identifies if there is a population subset that particularly benefited from the therapy. However, personalized medicine focuses on identifying baseline predictive markers that will reduce the trial and error effect in therapy selection. Increasingly, these baseline predictive markers are being incorporated early in the drug discovery process. So, experts say that further along the clinical trial spectrum—in phase II and […]