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.
Providing flexibility to an experimenter in meeting physical and practical constraints and ensuring efficient and cost-effective data collection methods in pharmaceutical, biotechnological, agricultural and engineering studies have thrown up unprecedented challenges to the design theorists in the field of statistics. The trade-off methodology dwells on an ingenious inter-play of subsets of "experimental designs", keeping the scientific information unchanged, or augmenting it in each iterative process. This trade-off methodology combines mathematical, statistical, and computational tools and holds rich rewards for those who master its secrets. In order to resolve the scientific issues mentioned above and to improve on the scientific information provided by a design, innovative design-based techniques using trade-off theory are developed, both in the classical sense as well as in the context of experiments being impacted by many factors. In addition to trade-off methodology innovative results on crossover designs for the purpose of controlling and reducing variability and the cost of the experiments as in biopharmaceutical trials, drug abuse liability trials, and in the evaluation of new drugs for unwanted effects on electrical properties of the heart, which includes QT/QTc cardiology trials in safety assessment have been conducted . The results have appeared in a book in addition to several peer reviewed journals. Further, the related discoveries have been disseminated to researchers and scholars in professional conferences. Nine doctoral students participated in the project. Six of these students obtained their PhD degrees and they are now employed by various organizations in the United States. Three of the graduated students were female. One graduate student who is involved with finalizing her dissertation is also a female. During the research several undergraduate students in UIC Honor College were mentored.
