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:
Click here to go the Tufts CSDD Impact Reports page.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.