Data Safety and Monitoring Boards Should Be Required for Both Early- and Late-Phase Clinical Trials
Gail A. Van Norman
Abstract
Phase I and II clinical trials increasingly combine therapeutic and toxicity endpoints. Recently, therapeutic agents have even achieved U.S. Food and Drug Agency approval based on early phase trials alone. These developments point to new challenges in assuring the safety of human research subjects and patients. Given their size and use of real-world patients, phase III studies warrant independent monitoring by a Drug Safety Monitoring Board (DSMB). Requirements should also be extended to include many phase I and II clinical trials. Measures should be taken to establish and standardize minimum qualifications for service on a DSMB.
Topics & Concepts
Clinical trialMedicineIntensive care medicineSafety monitoringData monitoring committeeFood and drug administrationPhase (matter)Phases of clinical researchEnd pointPharmacologyInternal medicineBioinformaticsComputer scienceOrganic chemistryChemistryBiologyReal-time computingStatistical Methods in Clinical TrialsHealth Systems, Economic Evaluations, Quality of LifePharmaceutical Economics and Policy