CDER s Clinical Consideration for First-in-Human Trials Can the trial proceed? Yes or No If yes, with contingencies or not? If no, partial hold or complete hold from the trial proceeding? E g , One Grade 5 event or 2 Grade 4 events should halt study
Design and Conduct Considerations for First‐in‐Human Trials The dose escalation continues until at least two patients within a cohort of three to six patients experience a DLT The MTD or recommended phase II dose is the dose below the level that is too toxic
Sentinel Initiative - fda. report What follows in this report are the summary findings from a comprehensive final assessment of Sentinel designed to assess the maturity of Sentinel and how it affects regulatory decision-making on safety issues
Sentinel Dosing: Ensuring Safety In Drug Development This aims to assess the drug’s safety and tolerability before proceeding to higher doses Regulatory agencies like the FDA closely monitor sentinel dosing, ensuring patient safety and providing guidance for clinical trial conduct and drug approvals
Designing Dose-Finding Phase I Clinical Trials: Top 10 Questions That . . . The goal of this paper is to provide guidelines for appropriate questions that should be considered early in the design stage to facilitate the interactions between clinical and statistical teams and to improve the design of dose-finding clinical trials for novel anticancer agents
Oncology Center of Excellence Guidance Documents | FDA For information on a specific guidance document, please contact the originating office Another method to obtain guidance documents is through the Division of Drug Information
The New First-in-Human EMA Guideline: Disruptive or Constructive . . . The revision gave guidance on sentinel dosing staggering of subjects within a multiple-ascending dose (MAD) clinical trial, permissible maximum exposure investigation of supra-therapeutic doses and dose escalations above the no-observed adverse effect level