Tufts CSDD Impact Report on European-Specific Clinical Trial Under-Representation

Tufts CSDD released its May/June Impact report featuring demographic under-representation in clinical trials in Europe. The report summarizes analysis of a dataset made up of 1,731 clinical trials and 943 pivotal trials—representing 446 drugs and biologics—supporting EU Commission approvals of new medicines under the Centralized Procedure between 2007 and 2019. The data were collected using EMA Annual Reports, the annexes to the Annual Reports, the Human Medicines Highlights, EudraCT, European public assessment reports and other public resources.

Highlights include the following:

  • During 2007-19, only 64% of pivotal trials supporting the EU Commission approval process reported any data on study participants’ race, and only 29% provided data on ethnicity.
  • The percentage of Black participants decreased significantly, while the percentage of Asian participants increased between 2007 and 2019. No significant changes were observed among other demographics.
  • Although demographic reporting has increased over time for both EU and FDA, the results in the most recent time period still show a high level of under-reporting.

Click here to go the Tufts CSDD Impact Reports page.