Clinical Trials and Biometry Division of the Wilmer Ophthalmological Institute

Clinical Trials and Biometry Division of the Wilmer Ophthalmological Institute

Background

In order for a new treatment to move from the laboratory of an individual researcher to availability in the ophthalmology clinic a number of steps are required. In many cases, the important final step is evaluation of the new treatment in a large clinical trial. In a clinical trial, the new treatment is compared to one or more other treatments, when available, or to no treatment. The outcome of interest in the clinical trial typically is a measure of visual function, such as visual acuity or visual field, but may be a measure of patient satisfaction or vision-related quality of life or benefit relative to cost.

The Wilmer Ophthalmological Institute has a long history of commitment to and participation in clinical trials in order to give their patients new preventive or therapeutic treatments. Since the 1950s, individual faculty members have been instrumental in designing, conducting, analyzing, and reporting findings from national and international clinical trials in ophthalmology. In the 1970s, Argye I. Hillis, Ph.D., the first biostatistician at Wilmer, was recruited to join the faculty. Under her leadership, the group that later became the Clinical Trials and Biometry Division had its genesis. In February 1987, the Division was formally established when it moved into new quarters on the ninth floor of the 550 Building of the Johns Hopkins Medical Institutions campus. From the beginning, the Division has had strong ties with the Johns Hopkins School of Public Health to complement expertise in the School of Medicine.

Mission

The mission of the Clinical Trials and Biometry Division of the Wilmer Ophthalmological Institute (WCTB) is to take a leadership role in designing, conducting, and reporting large clinical trials and similar studies in ophthalmology; to collaborate with colleagues at Wilmer to identify treatments that should be tested in clinical trials and to carry out necessary preliminary studies and investigations; to improve methods of designing, conducting, and reporting clinical trials to be more efficient; and to train future clinical trialists, particularly those interested in clinical trials in ophthalmology; and to design and conduct epidemiologic investigations in important areas of ophthalmology.

Large clinical trials pose both scientific and management challenges to those who are responsible for designing and conducting them. The methods used must be scientifically valid, practical, and efficient so that the findings will be accepted by the ophthalmologic community, applicable in clinical practice, and available as soon as possible. In multicenter clinical trials in which many ophthalmologists participate, investigators at a central office, usually called the coordinating center or the statistical center, play a key leadership role.

WCTB faculty and staff are known worldwide for their expertise in clinical trials. WCTB has housed the coordinating centers for several large national and international clinical trials in ophthalmology, including the Macular Photocoagulation Study, Collaborative Corneal Transplantation Studies, the Collaborative Ocular Melanoma Study, and the Submacular Surgery Trials. All of these trials have been sponsored by the National Eye Institute of the U.S. National Institutes of Health. The National Eye Institute currently also is supporting a study of quality of life of patients with choroidal melanoma which was designed and coordinated from WCTB. Funding from the National Eye Institute to carry out specific clinical trials is the major source of support for WCTB. During the design and development phase of each clinical trial, a number of smaller research projects may be required that may range in size from retrospective reviews of records of 20 or 30 patients, to methodologic investigations of techniques to be used in a larger study, to pilot clinical trials to evaluate methods in patients similar to those to be enrolled in large trials. Epidemiologists and biostatisticians from WCTB work with colleagues at Wilmer to design and carry out these early investigations.

WCTB Faculty Members

Marta J. Marsh, MS
Assistant Professor of Ophthalmology