How useful are observational data for drug regulatory decision making?

09 Mar 2017

We have just been awarded a grant by the Association of the British Pharmaceutical Industry to determine how observational research using electronic health records is used in the regulatory decision making process in Europe. Every year, many studies about drug risks and benefits are published, and they often rely on the use of electronic health records. What we don’t know is how useful these studies are when policy decisions need to be made about drug risks and benefits. This systematic assessment of the evidence will answer this question and also help us to better define future research questions to ensure they are useful for decision makers.