This morning's meeting started off with a panel discuss on the new European rules to make patient level data available to the public for all commercially sponsored studies and whether we should do the same in the US. On the panel were representatives from the FDA (Janet Woodcock), the European Medicines Agency (EMA is the FDA equivalent in Europe), PhRMA (representing industry) and patient advocacy groups.
In the US, we now have a requirement to post (through clinicaltrials.gov) information about every human subject clinical trial along with overall results. In Europe, they are taking it to another level (more information is available on the EMA website) with patient level data (de-identified for confidentiality) so all trial results are publicly available. This could potentially happen even before the drug/device gets approved or the study is published. This is a very interesting development that has policy, regulatory, commercial and ethical implications for the sponsor, study site, investigator and patient. It will be interesting to see how this plays out in Europe and what happens in the United States.