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Precision medicine requires a different type of clinical trial that focuses on individual, not average, responses to therapy, says Nicholas J. Schork.
Every day, millions of people are taking medications that will not help them. The top ten highest-grossing drugs in the United States help between 1 in 25 and 1 in 4 of the people who take them (see 'Imprecision medicine' ). For some drugs, such as statins — routinely used to lower cholesterol — as few as 1 in 50 may benefit. There are even drugs that are harmful to certain ethnic groups because of the bias towards white Western participants in classical clinical trials.
Recognition that physicians need to take individual variability into account is driving huge interest in 'precision' medicine. In January, US President Barack Obama announced a US$215-million national Precision Medicine Initiative. This includes, among other things, the establishment of a national database of the genetic and other data of one million people in the United States.
http://www.nature.com/news/personalized-medicine-time-for-one-person-trials-1.17411
(Score: 2) by sjames on Tuesday May 05 2015, @09:36AM
That's not really what is being suggested. Instead, a drug may show an effect in aggregate but in fact turn out to help (for example) half of the treatment group and do nothing for the other half.
There is a real need to follow the effects on the individual to better identify the subset that was greatly helped vs. the subset that gained no benefit. "Individualized trials" is an analysis method in addition to analysis in aggregate.
Once past the trial, individual patients need to be followed up to see if their treatment is actually having the desired result. There';s a lot of people taking a lot of statins, for example, and deriving no benefit at all from them.