Is it Time to Abandon the Use of P-Values in Early Phase Translational Trials: Why (Effect) Size Matters:
∗Address for correspondence: Dr Douglas L. Mann, Editor-in-Chief, JACC: Basic to Translational Science, American College of Cardiology, Heart House, 2400 N Street Northwest, Washington, DC 20037, USA. E-mail: E-mail Address: [email protected] Ph ase 1 clinical trials are primarily designed to test the safety of new drugs or devices. However, increasingly, phase 1 studies are being used as hypothesis-generating studies to help inform endpoints for larger phase 2 studies. Traditionally, researchers have