Imagine you enter a hospital with a specific set of symptoms. Your caregiver takes your standard baseline temperature and blood pressure measurements, then takes a quick, non-invasive biologic sample. A few minutes later, he or she returns with a treatment plan backed by data compiled via hundreds of thousands of clinical-trial participants whose profiles are similar to yours and whose outcomes fared best with the course of treatment offered.
Crowdsourcing genetic profiles with PrecisionFDA
Dec. 15, 2015, witnessed the beta release of PrecisionFDA, “… a secure, cloud-based platform where participants can access and share datasets, analysis pipelines, and bioinformatics tools, in order to benchmark their approaches and advance regulatory science.”
The Precision FDA platform is designed to make President Obama’s Precision Medicine Initiative a reality. The initiative “seeks to identify genetically-based drivers of disease in order to develop new, more effective treatments.”
The initiative is closing in on individualized treatment plans based upon genetic information or “precision medicine.” Doctors and scientists input information, algorithms, treatment options, and patient outcomes. Members review findings and make recommendations, corrections, additions and evaluations in a secure, globally collaborative environment.
How precision medicine works
Clinical trial participants and individuals suffering from diseases will belong to a non-identifiable database where the results of their experiences will be filed and accessible to member healthcare providers.
New sample data will be compared and contrasted within the database using complicated algorithms. The algorithms will compare samples against existing data and deliver optimal treatment options by running simulated clinical trials for the individual’s genetic profile.
Clinical data from over 100 years of clinical trials will enable physicians to prescribe treatment from an impressive vantage point.
PrecisionFDA is a central location within the cloud where the results of that work can be discussed and reviewed by peers.
Pros and cons of precision medicine
In a personal interview, Jesse Null, Basic Science and Clinical Research Manager for the Department of Surgery, Cedars-Sinai Los Angeles explained the primary advantage of precision medicine: “At Cedars, we utilize in-silica models bioinformatics and Next Gen sequencing to optimize an individual patient’s course of treatment. PrecisionFDA will allow our clinic to leverage big data informatics to reduce decision times for optimal treatment.”
On the other hand, with personal medical information being stored in the cloud, concerns about security are high for many. In FDA Crowdsourcing Its Way to Precision Medicine. But What About Security?, Nextgov columnist, Hallie Golden, states, “The team has not yet determined exactly how it plans to vet people who seek access to the platform.”
Commercialization is also a concern. If not protected, information from the platform could be commercialized against the intention of open access. Linux anyone?
In the end, having global, collaborative open access to clinical trial data is generally considered imperative for doctors to make the best treatment decisions for their patients. But do the benefits outweigh the potential drawbacks? Only time will tell.