What I am working on now
Can a drug safety study stay fair when each site has few patients?
Once a medicine is on the market, safety studies compare the people who take it with people who take another one. That is only fair if the two groups are alike. With few patients per site, the standard way of making them alike can fail, and it fails most often right after approval, when few people have taken the new medicine yet.
My Innovation Mandate takes the methods from my multiple sclerosis work to this problem. The data are Optum's health records and insurance claims from the United States. In them, payers, providers and regional health systems act as the sites.
- Not shown yet
- Whether the methods carry over. In my multiple sclerosis study each patient was a few dozen clinical measures, while in claims data a person is a very long list of billing and diagnosis codes.
- How I will judge it
- Step by step against what is done today: whether the two groups end up alike, and whether that holds without adding bias.
- Who this is for
- Teams that run safety studies across sites, and anyone whose network is made of many small ones.
An Innovation Mandate: a personal grant from the Flemish government, with Johnson & Johnson Innovative Medicine as industry partner.
How it came about