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Population Sciences

The ITM Population Sciences Cluster provides CTSA trainees and investigators with support and education in study design, biostatistics, epidemiology, research ethics, health outcomes analysis, and epidemiological investigation. The Population Sciences Cluster is led by Ronald Thisted PhD (Chair, Dept of Health Studies) and Lainie Ross MD/PhD (Prof of Pediatrics and Assoc Director of the MacLean Center for Medical Ethics). The Cluster has area leaders in each of the principal disciplines represented: Theodore Karrison PhD (biostatistics), Diane Lauderdale PhD (classical epidemiology), Jerry Krishnan MD/PhD (clinical epidemiology), Marshall Chin MD/MPH (health outcomes), and Mark Siegler MD (clinical medical ethics).

The Cluster sponsors a Population Research Methods Unit (PRMU) that provides integrated, interactive, and collaborative access to the Cluster's key methodologies for all ITM investigators and trainees. The PRMU will draw on and expand access to resources in epidemiology/biostatistics, outcomes, and research ethics that are currently available either to a restricted set of investigators or as one-time consultation services. The PRMU represents a single point of ongoing access to expertise in all of these disciplines. PRMU collaborators will participate from inception through completion of studies in a coordinated team effort. The PRMU will provide support for Biostatistics and Epidemiology, including research study design and data analysis support through the Biostatistics Laboratory. Expertise in data collection instruments and their validation and in large-scale public-use data sets will be provided by professionals from the Health Outcomes Core of the Center for Health and the Social Sciences. The Research Ethics Consultation Program of the MacLean Center for Clinical Medical Ethics serves as foundation for the PRMU's efforts to help investigators describe, understand, and negotiate the ethical issues that arise in the course of conducting innovative translational research. In all, these intellectual-capital intensive "dry core" services will greatly enhance the efficiency and ultimate value of our clinical and translational studies, by ensuring robust study designs, proper interpretation, and ethical per-formance. By integrating access through a single point of contact – the PRMU – and by participating continuously through the life of a project, the PSC will have a transforming impact on our research.

The Biostatistics Laboratory offers state-of-the-art collaboration with investigators in the areas of study design, data acquisition, and statistical planning and analysis. Despite its name, the Laboratory encompasses a broad range of methodological expertise. The Lab currently has 9 full-time PhD experts in biostatistics, epi-demiology, genetics, and related fields, 3 professionals with MS-level training in biostatistics, and 3 staff with BS or MS-level training in computer science. Laboratory members have substantial experience in protocol development; data analysis and statistical computing; execution of phase I, II, and III clinical trials; case-control and prospective cohort studies; data quality control; interaction with data and safety monitoring boards; and generating statistical reports for both safety monitoring and publication. The Biostatistics Lab has funded collaborations with every clinical department. It staffs the UCCRC and GCRC Biostatistics Cores, provides biosta-tistics and epidemiology support for the Breast Cancer SPORE, multiple PPGs, and collaborative agreements, and serves as Data Coordinating Center for the NIH Consortium on Genetics of Inflammatory Bowel Disease.

Theodore Karrison PhD, the senior statistician for the GCRC and UCCRC, directs the Biostatistics Lab and is the area leader for Biostatistics. Lab biostatisticians and epidemiologists work closely with Dept of Health Studies faculty, including biostatisticians James Dignam PhD (breast and prostate cancer clinical trials), Paul Rathouz PhD (likelihood methods, psychiatric statistics), Vanja Dukic PhD (reproductive endocrinology, epi-demic models, Bayesian methods), and Tyler VanderWeele PhD (causal inference). Examples of work by PSC biostatisticians include Dr Dignam’s investigation of how characteristics such as obesity influence cancer prognosis and alter the efficacy of treatment regimens; Dukic and Dignam’s development of multiresolution Bayesian methods for studying time-dependent failure patterns in cancer treatment, Dr Rathouz’s innovative methods for dealing with incomplete data, and Dr Karrison’s contributions to response-adaptive designs for clinical trials.

Epidemiology is led by area leader Diane Lauderdale PhD, Associate Professor in the Dept of Health Studies. Dr. Lauderdale studies the epidemiology of sleep; osteoporosis; and ethnic disparities in health risk. Within the Biostat Lab, epidemiology is led by Dezheng Huo MD/PhD, the senior epidemiologist in our Breast Cancer SPORE. Collaborating faculty epidemiologists include Habibul Ahsan MD (genetic differences and environmental effects of arsenic exposure), Benjamin Lahey PhD (psychiatric epidemiology), Lianne Kurina PhD (stress and cardiovascular disease), Jerry Krishnan MD/PhD (clinical epidemiology; asthma), and Rebecca Lipton PhD (epidemiology of pediatric diabetes). A few examples illustrate the range of epidemiologic work represented in the PSC. Dr Lipton’s registry of diabetic children in Chicago, the largest of its kind, has made it possible to study the impact of health attitudes and behaviors on risk of diabetic complications as well as ge-netic and metabolic risk factors. Dr. Ahsan has made key discoveries on the health effects of low-dose arsenic exposure and genetic variability in susceptibility to arsenic-induced cancerous and precancerous lesions. Dr Lahey’s epidemiologic work has led to the diagnostic criteria now used worldwide for conduct disorder and at-tention-deficit hyperactivity disorder in children. These epidemiologists will also work closely with clinical epidemiologists of the Community Translational Science Cluster. Indeed, clinical epidemiology has been a key required course in the Pritzker School of Medicine since 1990, taught by Drs. Thisted (Health Studies and PSC) and Ewigman and Hickner (Family Medicine and CTSC). Faculty and Biostat Lab members regularly teach critical appraisal methods; these efforts will be integrated with the Training Cluster. In addition, they have sub-stantial experience and peer-reviewed publications in such areas as risk stratification, cost-effectiveness analysis, medical decision making, evaluation of diagnostic tests, and development of clinical prediction rules.

Health Outcomes support is coordinated by area leader Marshall Chin MD/MPH, Assoc Professor of Medicine, an expert in health outcomes translational research and improving chronic disease care for vulnera-ble patients in resource-constrained settings. He oversees the Health Outcomes Core in the Center for Health and the Social Sciences, which will provide substantive content area and methodological support to investiga-tors performing research that aims to translate knowledge into real-world settings to improve health outcomes. Population translational research draws upon clinical, social science, and quantitative disciplines, and utilizes multiple methodologies. Specific disciplinary and methodological expertise will be supplied for health services research, behavioral science, organizational theory, survey research, qualitative techniques, large administrative database research, cost analyses, and related data management and analysis. Additional expertise is provided by Lawrence Casalino MD/PhD (physician response to incentives, quality care processes), Kathleen Cagney PhD (neighborhood effects on health and health care), Tamara Konetzka PhD (effects of insurance on utilization), Willard Manning PhD (cost-effectiveness analysis) David Meltzer MD/PhD (health economics and policy), Juned Siddique PhD (statistical methods), and Farr Curlin MD (survey methods).

Research Ethics support, under area leader Mark Siegler MD, Director of the MacLean Center for Clinical Medical Ethics, will extend the Center’s Research Ethics Consultation Program, whose mission is to describe, analyze, and manage the ethical dilemmas that may arise in the course of conducting innovative translational research in areas such as genetic testing, risk assessment, screening, high risk therapies or other areas where scientific investigation may conflict with ethical norms. Lainie Ross MD/PhD, co-leader of the PSC, is an international leader on issues in medical ethics and public policy, particularly in the areas of organ transplant and genetic screening, pediatric research ethics and genetic screening. She served as the ethics consultant to Pediatric Research in the Office Setting, and has just published a book: Children in Medical Research: Access versus Protection (Oxford University Press, 2006).

For the last 15 years, Drs Ross, Siegler, and colleagues have pioneered an approach to ethical conflicts in research called "research ethics consultation." By this approach, ethicists work closely with researchers to de-velop protocols that proactively address difficult ethical concerns. An example is a collaboration with UC hepatologists and liver transplant surgeons where a 2-stage consent process for the first live donor liver transplanta-tion was developed. This was a complicated protocol because it involved a child as recipient and parent as donor. The protocol that emerged from this discourse has become the "standard of care" for all programs throughout the world performing live liver donor transplants. In another example, pediatric oncologists proposed a protocol to treat sickle cell disease with bone marrow transplantation. The UC IRB rejected the proposal as too risky, which led the ethics team to survey parents to learn their opinions about whether such a protocol ought to be offered, and found that they weighed the risks and benefits quite differently. The protocol was ultimately approved by the IRB. These examples illustrate the following program characteristics:

1. Early consultation with researchers on issues of subject selection, consent, study design and data analysis.
2. Publication of ethical analyses of research dilemmas so that others may learn from our experience
3. Identification and analysis of hot-button issues that might delay IRB approval
4. Collaboration to analyze unforeseen ethical issues that arise during the conduct of innovative research.

The existing resources for this program are provided by the MacLean Center for Clinical Medical Ethics with its 12 faculty from Medicine, Pediatrics, Surgery, Psychiatry, Obstetrics, and Nursing, and from the Divinity School, the Law School, and Sociology. The MacLean Center has a fellowship in Clinical and Research Ethics. Through the PRMU, we will formalize the research ethics consultation we have provided on an ad hoc basis for 15 years and make it routinely available to clinical and translational researchers throughout the University.