The Evaluation of Evidence for Regulatory Decision Making
The Importance of the Clinical Research Enterprise in Assuring its Quality and Success
2017 SOCRA Annual Conference Opening Plenary
Dr. Robert O'Neill, PhD, Senior Statistical Advisor, FDA
Virtually every clinical study of a medical product that reaches Phase II or Phase III can have commercial implications and will be subject to regulatory oversight (e.g. IND or IDE), and eventually regulatory review if submitted to support market approval and health claims. Dr. O'Neill will discuss important aspects of study planning, conduct, analysis, reporting, quality assurance, monitoring, staff training and competencies relevant to the clinical research enterprise. The perspective will be that of the regulatory scientific review of evidence to support claims and the components of that process.