Current Edition

Real-world Data can Bridge the Gap Between Traditional Trials and a Patient-centric Future

Patient safety has been the primary focus of clinical trial design since 1947 when the Nuremberg Code outlined the ethical guidelines for clinical research. Consisting of ten points, those most directly relating to patients dictated that trials must be designed to avoid all unnecessary injury or suffering, that patients must give consent and are free to leave the trial at any point. Karen Ooms at Quanticate discusses that the Code pervades all existing guidance and the current world of drug development governed by ICH GCP makes it mandatory to have all necessary steps taken by sponsors, CROs and investigators to keep patient safety as the utmost priority.