Accelerated approvals (AA): not so fast!
Everardo D. Saad, MD, Medical Director and Consultant, IDDI Marc Buyse, ScD, Chief Scientific Officer and Consultant, IDDI The development…
Everardo D. Saad, MD, Medical Director and Consultant, IDDI Marc Buyse, ScD, Chief Scientific Officer and Consultant, IDDI The development…
Ensuring clinical data is ready for regulatory submission This eBook is a must-read that will enable clinical professionals to better…
Randomized controlled trials (RCTs), particularly in phase 3, are the preferred sources of evidence for drug approval and reimbursement decisions….
The COVID-19 pandemic has a major impact on the conduct of most on-going clinical trials, in particular on the treatment…
The need to consider randomization whenever feasible in expansion cohorts The purpose of IDDI comments on FDA Draft guidance is to…