ABSTRACT
The Institute of Medicine and US Food and Drug Administration (FDA) recognize that activating clinical trials in the United States is lengthy and inefficient. Downstream consequences include increased expense, suboptimal accrual, move of clinical trials overseas, and delayed availability of treatments for patients. An in-tandem processing initiative is here highlighted that transformed the activation of clinical trials (TACT), reduced the activation time by 70%, and offers a paradigm for enhanced translational readiness.
Subject(s)
Clinical Trials as Topic , Drug Approval/methods , Translational Research, Biomedical , Clinical Trials as Topic/methods , Clinical Trials as Topic/organization & administration , Clinical Trials as Topic/standards , Evaluation Studies as Topic , Humans , Organizational Innovation , Quality Improvement , Translational Research, Biomedical/organization & administration , Translational Research, Biomedical/standards , United States , United States Food and Drug Administration/organization & administrationABSTRACT
Institutional review boards are charged with overseeing that human studies research is conducted in accordance with federal and state regulations and with their own policies and procedures, with the goal of minimizing risks to participants and maximizing the quality of the research data. Nutrition research often involves vulnerable populations, including children and the cognitively impaired, for whom there are specific regulations. Ethical issues are common in nutrition research, and both the investigative team and the institutional review board should seek input regarding ethical issues that arise.
