In return, “we the people” will have the benefit of this large set of anonymized health-related information when it comes time to treat our own diseases. Such collaboration between us and pharma companies could significantly reduce the cost, risk and timelines of new therapy development and make treatment much more precise.
In principle, it should be possible to match everyone in a trial against their own historical data as well as the data of a cohort that best matches that individual. And when the trial is over, the person becomes again the placebo control for themselves and for the other matched individuals.
These “crossover” trials could reduce or totally obviate the need for the use of placebo groups in double blind randomized placebo controlled trials which are so difficult to enroll and to interpret because of the limitation in numbers that make individual matching of placebo vs active groups impossible. In fact, such trials are in principle not designed to enable meaningful decisions about personalized therapies. I put my vote behind Eric Topol’s provocative proposal in his 2012 article, “Get Rid of the Randomized Trial; Here’s a Better Way.”
Most importantly, when a new therapy becomes commercially available, the same process can be used to optimize the treatment for that individual – by comparing the efficacy and safety in that person against their own historical data and the data of other people with similar characteristics, continuously enriching the precision of the decision making for each participating individual.
There are already examples of the power of this type of research published recently utilizing the large and detailed database of the Cystic Fibrosis Foundation in which retrospective “real world” trials were conducted to assess widely used medications in cystic fibrosis patients.
Many people have already shown a willingness to contribute data. PatientsLikeMe claims over 600,000 patient-volunteers contributing to their web-based information bank; in addition to information about their disease and the pros and cons of different treatments, some of them are already sending blood samples for analyses of biomarkers etc.
And 23andMe have over 5 million genotyped customers who not only contribute their genetic code to the common pool of knowledge by supplying a great deal of information about their own health as well as that of their relatives, but they have also paid for the privilege!
