Integration of the Basic and Clinical Sciences to Provide Training in Translational Research

The NIH and Congress have been concerned that the graduates of M.D./Ph.D. programs have not been conducting translational research. We contend that one of the reasons that M.D./Ph.D. students have not conducted clinical investigation (translational research) is that they have been only trained to conduct bench research and, therefore, when they complete all their training, they naturally continue their basic science research. In response to these concerns and keeping with the philosophy of the program which is to rigorously train M.D./Ph.D. students the program has a series of options available to its students that will allow them to receive training in clinical investigation, while still learning the rigors of hypothesis driven research. Below are listed opportunities that our program provides for its trainees to gain a better experience in translational research.

As part of the NIH roadmap initiative a major emphasis has been placed on clinical and translational research. The Medical University of South Carolina is committed to the concept of developing an enhanced infrastructure to facilitate clinical and translational research.

1. Medical Scientist Training Program Elective Clinic in Translational Sciences

Course # MDCOR-871
Course Co-Directors:
Perry V. Halushka, Ph.D., M.D. Program Director, MSTP
Lina M. Obeid, M.D. Associate Program Director, MSTP

Duration: 15 weeks (one 1/2 day per week)
Credit hours: 2.5 per semester.

The goal of this elective is for MSTP students to learn how to better integrate the basic sciences and their area of research interest with a meaningful clinical/translational experience. The elective is conducted during the student's Ph.D. training. The students are expected to discuss the patient's problems from a literature/research perspective. They will work in a clinic, one-half day a week with an extramurally funded clinician-scientist who is chosen based on his/her demonstrated commitment to research. This is an elective clinic and is not required of MSTP students. The mentors for this elective could help the students with a potential clinical study that may evolve from their basic science project. The course plan for the Elective Clinic in Translational Sciences follows:

Objectives

1. Create an environment where students begin to develop an appreciation for the process of translational research.
2. Introduce students to mentors who can serve as role models.

Structure

1. Requires prior approval from dissertation advisor and graduate program coordinator,
2. Students attend clinic no more than one half-day a week and with the same faculty mentor,
3. One semester blocks
4. Program will be pass/fail
5. one semester may be used to satisfy one month required for a clinical elective in the senior year of medical school.

Choosing Mentor: 1) A list of mentors who are clinician-scientists is provided and approved by the Associate Program Director and/or Program Director. 2) Whenever possible and/or appropriate the students will choose a mentor/clinic that is related to their dissertation research.

Schedule with Mentor: 1) Introductory period to gain familiarity with the clinic. 2) Mentor assigns patient(s). 3) Students will evaluate no more than one new patient per clinic and will see their return patients. 4) Students are responsible for patient care (history, physical examinations, diagnosis and treatment plan) while the patient is under the care of that clinic.

Clinical Research: 1) Students will research the latest concepts concerning the patient's disease and discuss them with the clinician-scientist.

Expectations of Students: Students are expected to: 1) demonstrate a detailed understanding of the pathophysiology and treatment of the disease, 2) provide support for diagnosis and treatment that they propose, 3) demonstrate knowledge of current literature and provide references and 4) acquire proficiency in the history and physical examination.

Expectations of Mentors: Mentors are expected to: 1) constructively challenge student's knowledge of current research literature, 2) practice evidence based medicine and 3) help the student gain skills in the history, physical examination, differential diagnosis and treatment.

Evaluation of the MSTP clinic in translational sciences: Both students and mentors will be required to fill out an evaluation form at the end of each semester.

2. Rotation in the GCRC

The General Clinical Research Center

During the senior year of medical school, MSTP students have the opportunity to spend a month in the General Clinical Research Center. The center is the hub of clinical investigation. The time is spent in a series of experiences that provide a significant exposure to clinical/translational research. Students spend time working with clinical researchers, attend Institutional Review Board meetings, attend GCRC advisory committee meetings, attend lectures about clinical research topics and meet with the support personnel for the GCRC. The major objective is for the student to write a clinical protocol based on the discoveries made during the basic science research that he/she conducted during the PhD years. A full protocol is developed along with an informed consent. The student works with a mentor and obtains all the help necessary to fully develop the protocol. At the end of the course the student formally presents his/her protocol to members of the GCRC and selected other individuals. While this experience per se will not make the student an accomplished clinical investigator, it will break down some of the myths and barriers real or perceived that have impeded MD/PhD students from conducting clinical research. Below is a representative schedule for the rotation in the GCRC for MSTP students.

Course title: General Clinical Research Center Rotation
Course Co-directors: Dr. Thomas C. Hulsey and Dr. Perry Halushka

Goal: Students will develop an understanding of and foundation in the principles of Clinical Investigation.

Objectives: Students will:

• Actively participate in the protocols being conducted in the GCRC
• Attend the GCRC advisory committee meeting.
• Attend an IRB meeting.
• Develop a clinical investigation protocol based on their dissertation research and present it for approval.
• Participate in the Controversies in Medicine Seminar Series.
• Learn statistical approaches used in clinical investigation.

Week 1: Introduction to GCRC and clinical research

Week 2: The research process

Week 3: Protection of human subjects

Week 4: Regulatory guidelines

Week 5: Manage a research study/project

Week 6: Communication of findings