The New York Times article also brings up the point that the genetic make up of each individual and the responses of those genes make it very hard to predict an outcome for individualized medicines. Later on in the article, this is a very important when they come to the discussion on how Phase I, II and III trials work. Leaf points out that doing tests on small populations can't even begin to replicate the genetic diversity that is seen once a drug goes to the market. Often drugs are tested for use on an older population, but younger individuals are the ones who are participating in the trial.
What does Leaf suggest could be the popular answer to all of this? Develop drugs that have a way to identify whether or not an individual's genes are likely to react to a medication. Do clinical trials based on whether or not it's likely to work in that person.
This past year at Partnerships in Clinical Trials, Dr. Eric Topol joined us and mirrored many of the sentiments that Leaf shares in his articles. Do clinical trials as they stand really work? And how can we make them or effective to treat patients better more often?