|GWU Biostatistics Center: About Us |
ACTIVITIES OF THE BIOSTATISTICS CENTER
STATISTICAL METHODS. The application of state-of-the-art statistical methods is required to insure that collaborative clinical trials and epidemiologic studies meet rigorous scientific and biostatistical standards. An important activity of the Biostatistics Center is the evaluation and development of new statistical methods to meet the unique needs of planned or ongoing investigations.
STUDY DESIGN. The careful design of the study plan in the successful conduct of any scientific investigation is an essential activity. The Biostatistics Center has actively participated in the statistical design of all types of medical investigations including multicenter therapeutic and intervention clinical trials, and epidemiologic cohort and case-control studies. Principal activities include protocol preparation, sample size evaluation, generation of randomization sequences and the implementation of quality assurance programs.
DATA MANAGEMENT. The Center has established procedures for all aspects of data management for the projects in which it participates. This is necessary to ensure that the data which is analyzed and reported in scientific publications is of the highest quality. This is a technologically demanding task because some of these studies are among the largest medical investigations conducted by the National Institutes of Health. Data management activities include forms design (and revision), centralized and distributed data entry procedures (with verification), extensive computerized data editing, computerized updating of corrections to master files, and organization of summary data files for specific statistical analyses.
STATISTICAL ANALYSIS AND PUBLICATION. The ultimate aim of these activities is to allow state-of-the-art statistical analyses of study results in order to address the scientific objectives of each study. The results of these analyses are usually summarized in a report which is used as a basis for the development of scientific manuscripts for publication. Periodically during each study, interim analyses are also performed to protect the welfare of patient participants.
ADMINISTRATION. In addition to these statistically-related activities, the Biostatistics Center has an administrative division which assumes various responsibilities associated with managing a university-based research organization. Direct on-site support services include financial management, business administration, contract and grant administration, and personnel services.
The George Washington University Biostatistics Center was established in 1972 within the GW Department of Statistics. The primary objective of the Biostatistics Center is to provide statistical leadership in the design, execution, and analysis of multi-center clinical trials and epidemiologic medical investigations, and to insure that the results of such studies are of the highest scientific integrity and meet rigorous biostatistical standards. These investigations include major medical research programs, especially multi-institutional studies of national and international scope, in both the public and private sectors. Such research provides a testing ground for new and developing statistical methods, frequently leading to major advances in the field of statistical methodology.
The Biostatistics Center has participated in dozens of major research projects, including both clinical trials and case control studies conducted under the auspices of the National Institutes of Health (NIH) and other Federal agencies, and also in collaboration with pharmaceutical companies in the private sector. In addition, the Center participates in population-based epidemiologic studies, and conducts grant-supported research in biostatistical methods. Through these activities, the faculty and staff of the Center have published hundreds of articles related to statistical methodology, clinical trials or epidemiologic methods, and many hundreds of articles presenting the results of medical investigations, and several books.
In the role of coordinating center for collaborative studies, the Center's functions include: statistical design of the study; development of data collection forms and manuals of procedures; all aspects of data management with emphasis on adherence to protocol and quality of data; training and certification of clinical personnel; generation of monitoring reports; development of new statistical methodology; statistical analysis of results; and preparation of statistical and scientific reports and publications.