Clinical-Scientist Training Program

Introduction

The Wilmer Ophthalmological Institute, founded in 1929, serves as the home for the Department of Ophthalmology, Johns Hopkins University School of Medicine. It has 92 full-time faculty members engaged in research and received more federal research direct support in recent years than any other ophthalmic department in the U.S. Total research support from federal, non-profit, and private sources totals over $20 million in direct costs annually.

The Wilmer Institute has been recognized nationally by the U.S. News and World Report survey and by vote of its peers as the premier ophthalmic teaching center in the United States (Ophthalmology Times). Patient-oriented research training for MD and PhD students has been an important goal for Wilmer. This is particularly important in the light of the recognition that clinician-scientists are becoming a smaller proportion of those conducting research and successfully competing for federal research dollars. To demonstrate our commitment to research training, Wilmer has several programs to develop the next generation of clinician-scientists (CS).

The Wilmer CS program utilizes multidisciplinary resources from the Johns Hopkins Schools of Medicine and Public Health. Laboratories of several departments have hosted CS trainees based at Wilmer. Other interactions that may be included in a CS program are the Clinical Research Center, the Welch Center, the Gerontology Research Center, programs in the Departments of International Health and Epidemiology at the School of Public Health, and the Clinical Trials Program of the School of Public Health.

Clinician--Scientist Program Description

A. Purpose and Objectives:

The objective of the Wilmer CS Program is to foster the development of clinician-scientists. As the largest and most active Institute for ophthalmic science, the Wilmer Institute has begun a program for CS development that utilizes governmental grants, private philanthropy, faculty commitment to education, and core facilities throughout the Johns Hopkins School of Medicine and the Bloomberg School of Public Health. The Wilmer program provides training in laboratory and clinical investigations, including methods of clinical trials, public health, epidemiology, and outcomes assessment. The specific objective is to provide the training and mentorship that will lead each trainee to be successful as faculty members in Schools of Medicine and Public Health with their own funded, independent research programs.

B. Program Description:

1. Overview: The Wilmer CS Program is an important commitment of our faculty. We use multidisciplinary research programs that provide training in innovative and effective approaches to the understanding of and therapy for visual disorders. We support several trainees in multiple areas in 3 to 5 year research training experiences. These include didactic instruction appropriate to the area being studied, training in laboratory techniques where this represents relevant approaches for the trainee, patient-oriented research experience with one or more Mentors for clinically oriented programs, and an environment that nurtures skills in human research ethics and methodology, along with practical skills in funding and collaboration.

2. Wilmer CS Training Programs: Since 1999, a Wilmer committee for CS training has concentrated on development of clinician-scientists under the Maumenee Program. Over a dozen CS trainees have entered academic ophthalmology after receiving CS training at Wilmer since 1985. Eight of these are present Wilmer faculty members: Donald Zack, MD, PhD, Richard Semba, MD MPH, Eliah Duh, MD, Peter Gelbach, MD PhD, Patrick Tong, MD PhD, Shannath Merbs, MD PhD, David Friedman, MD, MPH, and Nathan Congdon, MD MPH. Others have moved to successful academic careers at other institutions. Our CS program is presently training 10 mentees.

Before 2003, we funded CS training by helping candidates to apply for individual K08 or K23 awards, and this is still included in our overall approach. In 2003, we obtained the first K12 departmental CS program awarded by the National Eye Institute and candidates now have the option of occupying one of our 4 slots to begin CS training in similar fashion.

The CS training program can be coordinated with another research activity, the Public Health Ophthalmologist (PHO) program, centered in the Dana Center for Preventive Ophthalmology at Wilmer. This one-year academic program assists the clinician candidate in acquiring skills in epidemiology, biostatistics, and the specific problems relevant to visual disorders in the world. The Dana Center and the Hopkins School of Public Health merge public health and ophthalmology, offering the perspective of epidemiologic research and community-based action. The Dana Center, by virtue of its faculty of ophthalmologists, epidemiologists, and biostatisticians, can uniquely support this program. Each student enrolls in the Master of Public Health degree program of the School of Public Health, taking required courses and electives.

Another Wilmer research training program that can be coordinated with CS training is the Visual Neuroscience Training Program (VNTP). This multidisciplinary program trains candidates in research in the visual neurosciences as a collaboration of the Departments of Neuroscience and Ophthalmology. It combines research opportunities and a specially designed didactic program headed by Dr. Ruben Adler (Program Director).VNTP elective courses include laboratory methodology as well as patient-oriented research are: Cellular and Molecular Biology of Photoreceptors in Health and Disease (Adler and other faculty), Development of the Visual System (Sundin and Zack), Introduction to Visual Psychophysics (Massof and staff), Advanced Visual Psychophysics (Massof and staff) and Molecular Mechanisms of Sensory Transduction (Nathans). A series of seminars by invited speakers is offered as part of the VNTP. Our CS Program trainees will have access to VNTP lectures, and mentorship in patient-oriented research with mentors who are participants in the VNTP program.

3. Description of Wilmer CS Program
a. Summary: The Wilmer CS Program will build upon the framework that already exists for the programs that have successfully recruited and trained clinician-scientists. Clinicians who have completed specialty training in clinical medicine will be preferred for acceptance. They will engage in a 3-5 year program that includes an initial year of didactic coursework, including required courses in specific areas. They will identify on entry or within the first year a Lead Mentor and (where indicated) a team of other mentor faculty to supervise their training. They will use the multidisciplinary facilities, and define appropriate coursework and research endeavors. The CS Advisory committee will supervise the program.

b. Selection Process: The CS Program Advisory Committee will select trainees. Those applying for a position will be provided information possible programs and how these may fit into the personal needs of the trainee. Generally, candidates will be selected once per year in October, to begin in the following July; in some cases, programs may be considered to start at other times. During the application process, candidates will be put into contact with faculty members who might serve as the Lead Mentor. This will allow candidates to determine their level of interest and to ascertain the availability of courses, programs, research projects, and collaborative mentors. Simultaneously, these preliminary interactions will allow faculty to assess the likelihood that the candidate will be an appropriate match for training. The Advisory Committee will serve as a conduit for interactions between candidates and mentors. It will also keep track of these interactions by determining through telephone or electronic interview what were the strengths and weaknesses perceived by both candidate and mentor in each other and in the application process.

c. Design of Training Program: The time between selection and commencement of training will allow a finalization between the candidate and mentor(s) of the initial year of training in detail and a general plan for the entire 3-5 year program. Formal didactic courses will be applied for and a schedule for the first year settled upon. All trainees will accomplish required coursework, and in addition, there will be a wide variety of courses taken by each candidate depending upon their individual needs. The required coursework for all participants will include: 1) one course in Federal regulations on human subjects research and bioethics; 2) instruction in scientific integrity(conflict of interest, responsible authorship, policies for handling misconduct; 3) training in the responsible conduct of human and animal research; and 4) biostatistics and data management, including study design, analysis, and security of data records. These required areas will be selected by participants from the available offerings at the School of Medicine and School of Public Health, as approved by the mentor and Advisory Committee. In addition to the required didactic coursework, a variety of courses have been useful to our trainees. These will be selected with the advice of the mentor and Advisory Committee. For some candidates, the course work will lead to an advanced degree (MPH, MHS, PhD).

d. Example of a Training Program: The present plan designed by trainee John Kempen and his mentors illustrates the integration of didactic coursework into trainee plans. This training program involves research carried out within the Coordinating Center of the Studies of Ocular Complications of AIDS (SOCA) Research Group, under the primary mentorship of Dr. James Tonascia, a faculty member of the School of Public Health. SOCA is an on-going multicenter activity that designs and conducts clinical trials and epidemiological studies of ocular complications of AIDS. Dr. Sheila West, a senior ophthalmic epidemiologist, Dr. Douglas Jabs, chairman of SOCA, of the Wilmer faculty, and additional faculty of the Hopkins Center for Clinical Trials (School of Public Health) are assisting as a team in his training. During the period of the award, Dr. Kempen meets with Dr. Tonascia (Lead Mentor) weekly, with Dr. West twice a month, and with Dr. Jabs at least monthly. In order to assure optimal use of the training period, a mentor committee consisting of Drs. Tonascia, West, and Jabs meets with Dr. Kempen quarterly to review progress, and to outline goals for the upcoming three months. For this trainee, formal courses are taken in the following areas: 

1. Ethical issues
2. Data management
3. Assessment of sources of bias and confounding
4. Data analysis
5. Budgeting and business management

Attention was given in non-course seminar work to the following areas that were tracked in mentor meetings:

1. Critical literature review and synthesis
2. Study design and implementation
3. Oral presentation skills
4. Written skills

The majority of this course work was accomplished during the first year of study. For this trainee, the remainder of the course work was determined by the requirements for the PhD degree in Epidemiology. His research projects investigate quality of life outcomes and cost-effectiveness of AIDS treatments. He takes part in the outcome analysis of a clinical trial, for which Dr. Tonascia has primary responsibility. He will learn multi-center clinical trial methodology, incorporating quality of life and cost factors into analyses. He will be involved in the activities of a coordinating center team, including strategic planning, design of new trials, development of study forms, grant proposal preparation, study implementation and execution, data management and quality assurance, data analysis, ethical issues, and reporting of results. His degree of responsibility in these roles will be gradually increased over the award period as his capability grows.

These activities will occupy 90% of trainee time. During the remaining 10%, the trainee is funded by the Wilmer Department of Ophthalmology, participating in clinical activities within the Wilmer Ocular Immunology Service. The table shows time allocation for this trainee:

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