Alemayehu Demissie, Alvir Jose, Levenstein Marcia, Nickerson David
Specialty Care Business Unit, Clinical Affairs, Statistics (DA, JA, ML) and Worldwide Research & Development, Clinical Quality Management (DN), Pfizer, Inc., New York, USA.
Perspect Clin Res. 2013 Oct;4(4):221-6. doi: 10.4103/2229-3485.120171.
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.
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.
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.
Proper implementation of the strategy can help to optimize resource utilization without compromising trial integrity and patient safety.
确保患者安全以及试验质量和效率的有效临床试验策略涉及一种综合方法，包括前瞻性识别风险因素、通过适当的研究设计和执行减轻风险，以及实时评估质量指标。通过使用数据驱动技术来识别与试验相关的质量问题预测中最相关的风险因素，这种综合质量管理计划也可以得到加强。在本文中，我们使用从实际临床试验中收集的数据来说明这种方法。
采用了几种统计方法，包括Wilcoxon秩和检验和逻辑回归，以识别风险因素与质量问题发生之间的关联，并将其应用于辉瑞赞助的临床试验质量数据。
只有一部分风险因素与质量问题有显著关联，包括：研究是否使用安慰剂、药物是否为生物制剂、异常的包装标签、复杂的给药方案以及超过25项计划程序。
该策略的正确实施有助于优化资源利用，同时不损害试验完整性和患者安全。
