Development of Innovative Statistical Tools in Design of Scientific Experiments and Surveillance Studies

在制药、生物技术、农业和工程研究中，为实验人员提供确保高效和经济高效的数据收集方法的灵活性，给设计理论家带来了前所未有的挑战。研究人员在经典意义上以及在析因实验和交叉设计的背景下开发基于设计的创新技术，并立即应用于生物制药试验、药物滥用易感性试验和评估新药对心脏电特性的有害影响，其中包括安全性评估中的QT/QTC试验。及时检测和预防各种不良健康事件，如药物毒性，在与公共卫生有关的监测和IV期临床试验中正变得越来越重要。调查员还探索和开发了相关的创新监测战略，并对照几个众所周知的最佳标准，参照统计指标的作用[如虚警率、真实警报的延迟时间、可控平均运行时间]，检查了它们的相对表现。研究人员研究了在及时检测和干预的意义上，应以多高的频率和多高的效率监测不良事件发生率的策略。该项目开发了创新的统计理论和相关的计算方法，以解决一些关键的设计和监测问题，这些问题迄今尚未得到充分解决，涵盖制药、生物技术、农业和工程研究等领域。研究人员了解尖端技术，以处理实际生活中的一些问题，例如(I)环境因素对药品质量或药品或储存条件的保质期的影响，(Ii)医学和公共卫生中的监测问题[复杂的怀孕病例、大流行性流感、西尼罗河病毒、严重急性呼吸系统综合症[SARS]、空气/地表水中有害污染物的辐射排放]，以及第四阶段临床试验中的药物毒性研究。实践者利用这些发现在这些领域进行更有洞察力的实验和数据收集技术。高级本科生和研究生接受统计方法方面的培训。

Providing flexibility to an experimenter in ensuring efficient and cost-effective data collection methods in pharmaceutical, biotechnological, agricultural and engineering studies have thrown up unprecedented challenges to the design theorists. The investigator develops innovative design-based techniques, in the classical sense as well as in the context of factorial experiments and crossover designs with immediate applications in such areas as biopharmaceutical trials, drug abuse liability trials, and evaluation of new drugs for unwanted effects on electrical properties of the heart, which includes QT/QTc trials in safety assessment. The issues of timely detection and prevention of various types of adverse health events such as drug toxicity, are gaining importance in surveillance related to public health and phase IV clinical trials. The investigator also explores and develops relevant innovative surveillance strategies and examine their relative performance with respect to several well-known optimality criteria and with reference to the role of statistical indicators [such as false alarm rate, delay time for true alarm, in-control average run length]. The investigator examines strategies for determining how frequently and how efficiently the adverse event rate should be monitored in the sense of timely detection and intervention, incurring minimal cost.The project develops innovative statistical theory and related computational methodologies in resolving some critical design and surveillance issues, not adequately addressed hitherto, covering such areas as pharmaceutical, biotechnological, agricultural and engineering studies. Researchers learn about cutting edge techniques to deal with some real life problems such as(i) the effects of environmental factors on quality of drug substance or shelf life for drug product or storage conditions, (ii) surveillance issues in medical sciences and public health [complicated cases of pregnancies, pandemic influenza, West Nile virus, severe acute respiratory syndrome [SARS], emission of radiation from hazardous pollutants in air / surface / water] and in drug toxicity study in Phase IV clinical trials. Practitioners utilize the findings for more insightful experimentation and data collection techniques in these fields. Advanced Undergraduate and Graduate students are trained in the statistical methods.