title: A data-driven approach to quality risk management.
abstract: OBJECTIVE
  An effective clinical trial strategy to ensure patient safety as well as trial quality and efficiency involves an integrated approach, including prospective identification of risk factors, mitigation of the risks through proper study design and execution, and assessment of quality metrics in real-time. Such an integrated quality management plan may also be enhanced by using data-driven techniques to identify risk factors that are most relevant in predicting quality issues associated with a trial. In this paper, we illustrate such an approach using data collected from actual clinical trials.
  
  
  METHODS
  Several statistical methods were employed, including the Wilcoxon rank-sum test and logistic regression, to identify the presence of association between risk factors and the occurrence of quality issues, applied to data on quality of clinical trials sponsored by Pfizer.
  
  
  RESULTS
  ONLY A SUBSET OF THE RISK FACTORS HAD A SIGNIFICANT ASSOCIATION WITH QUALITY ISSUES, AND INCLUDED: Whether study used Placebo, whether an agent was a biologic, unusual packaging label, complex dosing, and over 25 planned procedures.
  
  
  CONCLUSIONS
  Proper implementation of the strategy can help to optimize resource utilization without compromising trial integrity and patient safety.
authors: Specialty Care Business Unit, Clinical Affairs, Statistics (DA, JA, ML) and Worldwide Research & Development, Clinical Quality Management (DN), Pfizer, Inc., New York, USA.
authors: Demissie
authors: D
authors: Alemayehu
authors: Jose
authors: J
authors: Alvir
authors: Marcia
authors: M
authors: Levenstein
authors: David
authors: D
authors: Nickerson
keywords: Clinical trial; compliance; quality risk management; risk assessment and mitigation