Clinical-Scientist Training Program Part 2

Clinical-Scientist Training Program - go to program home

e. Additional Illustrations of Multidisciplinary Trainee Programs: Three additional examples of programs for clinician-scientist trainees that are presently ongoing illustrate how our programs integrate expertise from outside Wilmer, and deal with important ophthalmic disorders as well as systemic problems.

1). Trainee David Friedman, MD MPH, recently completed a 5 year program entitled: Outcomes of Vision Restoration in Nursing Home Residents that prepared him to conduct patient-oriented research in ocular disease and outcomes research into the effects of ophthalmic treatment. Epidemiologist James Tielsch, of the School of Public Health, acted as his Lead Mentor. As in the example above, he attended required coursework and elective courses concentrated in the first year.

This has led to his completion of the requirements for the PhD degree in Epidemiology. The mentored research carried out by Friedman concentrated on interventions for vision restoration in nursing home residents His multidisciplinary team of mentor investigators included Epidemiologist Sheila West and Psychophysicist Kathleen Turano.

2). Trainee Nathan Congdon, MD MPH, engaged in a 5 year program: Clinical Trials in Cataract Prevention, a three-phase training program: 1) coursework in the theory of clinical trials at the Center for Clinical Trials under Dr. Curtis Meinert, and additional courses in biostatistics, epidemiology, ethics, and human subjects research ; 2) mentored research training in the Age-Related Eye Disease Study (AREDS), a randomized, controlled clinical trial prospectively exploring the impact of anti-oxidants and systemic health on the progression of age-related cataract (supervised by Study Chairman, Dr. Frederick Ferris (Wilmer faculty); 3) In the final phase of training, he designed and executed a follow-up on the Linxian Cataract Trial in China, the first randomized, controlled trial to demonstrate that supplementation with anti-oxidants might retard progression of cataract. Dr. Sheila West will be Lead Mentor through the three phases of training.

3) Trainee Ron Farkas, MD studied the molecular biology of glaucoma damage to retinal ganglion cells. His Lead mentor was Don Zack, MD, PhD and the faculty interacting as his mentor group included Harry Quigley, MD and Jeremy Nathans, MD, PhD. Dr. Farkas learned to manipulate rodent models of optic nerve disease, including experimental glaucoma and optic nerve transection. He constructed gene arrays that study specific groups of genes expressed by retinal ganglion cells, and studyied the changes in such expression when ganglion cell disease occurs. In addition, human tissues from persons with glaucoma were studied. Techniques that are applied in this work included Western blotting, transgenic mouse modeling, various forms of PCR technology, gene sequencing, viral vector gene therapy, and immunohistological microscopy. 

f. Research Environment, Resources, Facilities:
Candidates for the Wilmer CS Program will have access to Lead Mentors both within the Wilmer Institute and at other areas of the Schools of Medicine and Public Health. To illustrate the breadth of patient-oriented research programs within the Wilmer Institute, the following is a list of research groups and their faculty leaders:

It may be helpful to describe several of these groups within the Wilmer Institute to show the potential that will be offered to trainees by access to the group.

1)The Division of Ocular Immunology specializes in research and clinical patient care of patients with uveitis and is directed by Dr. Douglas Jabs. The group currently holds 11 NIH-funded grants, including leadership roles (study Chair) in epidemiologic studies and clinical trials. In addition, approximately 90% of patients with CNV Retinitis and other immune-mediated ocular disorders in the Baltimore metropolitan area are managed here, providing outstanding opportunities for clinical research on ocular complications of AIDS. A database of all AIDS patients has been maintained for approximately fifteen years, including demographic information, data on visual function, and dated entries of all diagnoses. Additional information is kept on patients diagnosed with cytomegalovirus retinitis and retinal detachment. It serves as clinical center for several multicenter studies, including the Cytomegalovirus Retinitis and Viral Resistance study, a prospective observational study. The office suite includes 2645 square feet of space, including a large conference room facility. The Division of Ocular Immunology has weekly administrative and educational meetings. 

2) The Dana Center for Preventive Ophthalmology is a joint undertaking of the Wilmer Institute and the School of Public Health, with faculty located at both sites. Its goal is "to bring a public health approach to the prevention and control of blindness in the U.S. and around the world". Activities include research, training, and development/implementation of blindness control programs. The center conducts research on the epidemiology and control of eye diseases both domestically and internationally. Faculty epidemiologists and biostatisticians include Drs. Sheila West, Oliver Schein, Beatriz Munoz, David Friedman, Nathan Congdon, Harry Quigley, and Emily West (offices at Wilmer), as well as Drs. Joanne Katz and James Tielsch (offices at the School of Public Health). The Center houses the Biostatistical Core Facility of the Wilmer Ophthalmological Institute. Numerous observational and interventional epidemiologic studies are ongoing on a variety of domestic and international topics. Some notable studies include elucidation of the role of Vitamin A in the prevention of blindness and early childhood mortality, cataract surgery outcomes studies, numerous eye disease surveys in several countries, development of reproducible systems for grading cataract, xerophthalmia, trachoma and glaucoma for epidemiologic research; development of a community-based intervention strategy to prevent trachoma; and population-based assessment of the functional impact of vision loss in elderly persons in a U.S. community (Salisbury, Maryland). The Dana Center is a World Health Organization Collaborating Center for the prevention of blindness. It assists in strategic planning for blindness prevention efforts, and shares responsibility for carrying out programs with academic institutions, international agencies, and private voluntary organizations. It is also a world leader in carrying out training programs, such as the PHO program described above. Trainees who choose mentored research in this area will follow a course either directly within the PHO program as it occurs, or an individual program that is similar to it.

3) The Clinical Trials and Biometry Group, headed by Dr. Barbara Hawkins, is the center at the Wilmer Institute for several major national clinical trials. Faculty members housed in Wilmer Clinical Trials and Biometry (WCTB) take a leadership role in designing, conducting, and reporting large, randomized clinical trials. They collaborate with Wilmer colleagues to identify treatments that should be tested in clinical trials and carry out necessary preliminary studies and investigations; conduct research to improve the design, conduct, and reporting of clinical trials; and train future clinical trialists, particularly those interested in clinical trials in ophthalmology. Expertise within WCTB includes biostatistics, epidemiology, computing and data management, quality-of-life assessment, and quality assurance and monitoring of clinical research. WCTB houses or has housed the coordinating centers for several large national and international clinical trials in ophthalmology, including the Macular Photocoagulation Study, Collaborative Corneal Transplantation Studies, Collaborative Ocular Melanoma Study, and the Submacular Surgery Trials, all sponsored by the National Eye Institute. Dr. Hawkins's clinical trial experience also includes roles in the Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity Trial, the Glaucoma Laser Trial, and the Early Treatment Diabetic Retinopathy Study, also sponsored by the National Eye Institute, and the University Group Diabetes Program that was sponsored by another NIH institute. One of the current multicenter studies now underway concerns quality of life among patients with choroidal melanoma, designed and coordinated within WCTB. Databases from completed and ongoing studies coordinated in WCTB are used to address methodologic issues in ophthalmology research and in the design and conduct of clinical trials. WCTB faculty and staff also engage in the design, conduct, and analysis of studies of other designs, often in collaboration with Wilmer colleagues or colleagues in the School of Public Health. WCTB faculty play a major role in activities of the Johns Hopkins Center for Clinical Trials, particularly with respect to developing and presenting short courses and symposia offered by the Center.

h. Resources Outside The Wilmer Institute
Trainees in the Wilmer Institute will routinely access the associated programs throughout the School of Medicine and School of Public Health with which collaborative, multidisciplinary programs can be constructed. Past or present, ongoing training experiences are now occurring with the following groups of researchers outside the Wilmer Institute, as illustrated above. While it is expected that all trainees will be studying visual disorders, the associated disciplines of study will vary widely and will take advantage of the diversity of both the Wilmer faculty and the resources of the Johns Hopkins campus.

1)The Center for Clinical Trials is a cooperative venture of the Departments of Epidemiology, Biostatistics, and International Health at the School of Public Health, and of the Departments of Ophthalmology, Medicine, and Oncology in the School of Medicine. The goal of the Center is "to promote the use of clinical trials as an evaluation method and to facilitate research and teaching efforts in relation to clinical trials and other studies". One Center's effort toward this goal has been the establishment of the Training Program in Vision Research, one of two such programs in the nation, which has included the training of vision researchers for nearly ten years. This program offers a monthly seminar series, and annual presentations by participants of research in progress. The senior personnel of the Center, Drs. Curtis Meinert and James Tonascia, have extensive background in collaborative design, conduct, and analysis of multicenter clinical trials and prospective observational studies (many in vision-related research), including the Diabetic Retinopathy Study, the Glaucoma Laser Trial Followup Study, the Coronary Drug Project, the University Group Diabetes Program, the Childhood Asthma Management Program, and other major trials. Wilmer Institute faculty members who are members of the Center include Drs. Barbara Hawkins and Marie Diener-West, important contributors to ophthalmic trials.

2) The General Clinical Research Center (GCRC) of the Hopkins School of Medicine is comprised of the following:

• The Pediatric Unit is housed on a newly completed 5,445 square foot facility, funded for about 500 research patient-days yearly, and over 1,400 out-patient visits.
• The Adult In-Patient Unit, on an 18-bed medical floor, is funded to cover up to 1,500 patient-days per year.
• The Adult Out-Patient Unit has over 8,000 visits annually, and is fully staffed to accommodate all sorts of protocols.
• The Neuro-Behavioral Research Unit, recently funded, featuring state of the art functional MRI capabilities, at the Kennedy-Krieger Institute. The GCRC also has support facilities to help investigators accomplish excellent research:
• The nursing and technical staffs are dedicated professionals, trained in the methods of research.
• There is a Bio-Informatics Core, with a fulltime system manager, which offers a wide range analytic and data analysis support.
• A dietary staff of 8.5 FTE is fully capable of whatever research nutritional needs exist.
• We have two MD/PhD Biostatisticians available (1.0 FTE) for consultation.
• GCRC Administrative staff is in place to assist in all elements of GCRC use.
  The Wilmer Institute has interacted with the GCRC in several past research and training endeavors. One area of interaction has been the study of systemic complications of therapy for HIV/AIDS. The GCRC Direction, Christopher Saudek strongly endorses our use of GCRC for the CS program (see letter of support, Appendix).

3) The Department of Epidemiology and International Health, School of Public Health has long-standing relationships with the Wilmer Institute for training and research. The Dean of the Bloomberg School of Public Health, Alfred Sommer, MD, was a Wilmer faculty member and founded the Dana Center for Preventive Ophthalmology described above. He directly participates in training in our PHO program, whose graduates receive the MPH degree. The Department of Epidemiology is the oldest autonomous Department of Epidemiology in the world, with 100 faculty members and post-doctoral students. Wilmer trainees have participated in departmental seminars, and the Division of Chronic Diseases journal club, which meets biweekly. In addition, the School sponsors a large number of special seminars on topics of general public health interest, to which trainees will have access. The Department of Epidemiology (through cross-appointed members of the Wilmer faculty, including Advisory Committee member Dr. Sheila West) offers full access to the academic resources of the School of Hygiene and Public Health and its library. Faculty in International Health has served as mentors in clinician-scientist (K23) programs based in the Wilmer Institute (Drs. James Tielsch and Joanne Katz). The interactions possible with these investigators are parallel to those in Epidemiology and broaden the scope of research to include a large number of patient-oriented health issues of worldwide interest.

4) The Johns Hopkins Program for Medical Technology and Practice Assessment is a center with the mission to define clinical, management and policy strategies that will contain health care costs while preserving or enhancing quality of care. To achieve this mission, Program faculty conduct research in the following areas: technology assessment, analysis of alternative clinical management strategies and practice variations, analysis of health care financing, development and application of methods for measuring quality of care, and use of practice guidelines and medical education to develop strategies for improving health care. The Program places a major emphasis on economic costs and quality of life in addition to clinical outcomes. One of the recent past trainees described above, Dr. David Friedman, conducted an extensive evaluation of the costs and outcomes of cataract surgery in collaboration with this Program.

5) The Welch Center for Prevention, Epidemiology and Clinical Research
The primary mission of the Welch Center for Prevention, Epidemiology and Clinical Research is to generate and disseminate the knowledge required to prevent disease and its consequences and to promote the health of the public. To meet this challenge, the faculty of the Welch Center integrates clinical expertise with a comprehensive knowledge of epidemiologic methods. The work in the Welch Center reflects the joint efforts of a group of faculty, staff and students dedicated to disease prevention, health promotion and evidence-based health practices. This work has three hallmarks. First, it is focused on diseases and conditions, which impose a substantial burden on the health and resources of the public. Second, it spans the full range of research methodology including observational epidemiology, randomized controlled trials and effectiveness and outcomes research. Third, it is fundamentally interdisciplinary and relies on active collaboration with faculty from throughout the Schools of Medicine, Public Health and Nursing because biologic, environmental and clinical factors interact in causing illness and disability.

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