To develop and integrate methodological and applied research for the design and analysis of clinical trials, advance statistical science in clinical trials, and put these novel methods into clinical and statistical practice, the center is comprised of five major components:

Methodological research
Applied interdisciplinary research
Education
Outreach to industry
Evaluation of clinical trials methods 

Methodological research - The Center will develop methodological research to advance statistical science in the arena of clinical trials. Methodological research areas include

• novel dose-finding methods in phase I clinical trials,

• methods for design and joint evaluation of efficacy and toxicity in phase II clinical trials,

• innovative methods for interim monitoring,

• adaptive methods for the design of phase III clinical trials,
  

• Bayesian approaches to the design and analysis of clinical trials,

• meta-analysis,
  

• cost-effectiveness,
  

• analysis of rare events,
  

• missing data,
  

• analysis of time-to-event data,
  

• design phase II clinical trials,
  

• analysis of longitudinal data, and
  

• categorical data analysis.
  

The UNC School of Public Health and its Department of Biostatistics have strong faculty members who have made contributions in these areas.  Their expertise, research depth, and focus are an important element of the Center.

(back to top) 

Applied interdisciplinary research - Center researchers who are part of the center will work with the academic and industry community locally, nationally and internationally to carry out interdisciplinary collaborative research on existing and future studies. The Center will work closely with the Collaborative Studies Coordinating Center (CSCC) to work on interdisciplinary projects together, to secure grants from the National Institutes of Health, and to secure partnerships with industry. The Center also will engage in applying new methodologies to existing and future studies that are or will be conducted both within and outside UNC.

(back to top) 

Education - The Center aims to increase the number of researchers and practitioners involved with clinical trials and to improve the quality of their work with a two-pronged approach. 

1. Center members teach graduate-level courses about clinical trials to master and doctoral students at the School of Public Health, at other universities in the United States and in other countries.
   
2. The Center will provide access to software, training, seminars and workshops to clinical-trial practitioners and researchers outside the university. 

Graduate-level courses for students

DESIGN AND ANALYSIS OF CLINICAL TRIALS (BIOS 752), offered by the Department of Biostatistics, provides comprehensive coverage on methods for Phase I, II, and III clinical trials for PhD students.

CLINICAL TRIALS IN EPIDEMIOLOGY (EPID 733), co-taught by the departments of Epidemiology and Biostatistics, gives a systematic overview of principles in design, implementation and analysis of clinical trials, with an emphasis on case examples from cardiovascular disease epidemiology.

These courses encourage students, post-doctoral fellows and faculty to learn about the most recent developments in clinical trials and will facilitate further research by students and faculty, thereby enhancing the research activities of the Center.

As the Center develops and grows, it is likely that more graduate-level courses about clinical trials will be created and made available to students in a variety of departments at the School of Public Health.

Training for practitioners and researchers

In the near future, the Center will obtain state-of-the-art software packages to train community practitioners and researchers in clinical trials design and analysis. In addition to training practitioners and researchers to use the software, the Center will sponsor a regular seminar series on research issues in clinical trials, pulling speakers from both within and outside the university and will occasionally host research workshops for discussions on current research issues in clinical trials. The Center will also host workshops and short courses on clinical trials, primarily to educate academics and practitioners on methods for clinical trials.

(back to top) 

Outreach to industry - The Center will serve the research needs of the industry community by forming research partnerships with industry and forming interdisciplinary research teams from academics and industry to solve important research problems in clinical trials. Joint research partnerships will not only result in the development of new statistical methods for clinical trials, but also have the potential of making a tremendous impact on the implementation of new methods in industry and of shaping the practice of clinical trials in the statistical and biomedical community. These partnerships will be essential to create the methodological and applied interdisciplinary balance sought by the Center and will give the Center the unique opportunity of being influential in shaping the direction of the field.  This opportunity has unlimited local and global potential since there are a vast number of pharmaceutical companies and contract research organizations in nearby Research Triangle Park, North Carolina.

(back to top) 

Evaluation of clinical trials methods - The Center is well poised to evaluate new clinical trials methods in terms of cost effectiveness, regulatory issues and health policy with the contributions of outstanding UNC colleagues who have expertise in health policy and economics. For regulatory issues, the Center will be engaged in forum training with the Food and Drug Administration (FDA) and will conduct joint workshops on various design and analysis issues in clinical trials and to provide major input on the most recent, cutting-edge and useful methodologies for the conduct of clinical trials. In this way, the Center can have a direct impact on regulatory issues related to the FDA as well as set the tone and serve as model to other academic centers, industries and regulatory agencies worldwide for the conduct and evaluation of clinical trials.

Through its research and interdisciplinary work, the Center seeks to influence policy, decision-making, research directions and initiatives in clinical trials at the federal and global levels.