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

Time	Monday	Tuesday	Wednesday	Thursday	Friday
8:00-9:00	Introduction to GCRC Welcome	Overview of basic, clinical and translational research	Select PI or research mentor	Collaborative research models and opportunities on campus	Independent research project; Spend time with PIs/mentors; Library time
9:00-10:00	Intro continued: Lab, nutrition, dexa, etc.	CTSA	Take CITI course	Collaborate models continued
10:00-11:00	Introduction to good clinical practice	Review GCRC studies	Continue CITI course	Community-based participatory research models
11:00-12:00	Campus resources	Review GCRC studies	Funding opportunities	CBPR models continued
12:00-1:00	Lunch	Lunch/Translational seminar series (last Tuesday of month)	Lunch	Lunch
1:00-2:00	Tour of campus research offices (ORP, IRB, etc.)	Attend GCRC in-services for coordinators (last Tuesday of month)	Funding opportunities continued	NIH online training

Week 2: The research process

Time	Monday	Tuesday	Wednesday	Thursday	Friday
8:00-9:00	Discuss and select project for clinical project: evidence-based medicine (EBM), systematic review of literature, or research study	Meet at Writing Center	Research designs continued	Sampling plan including sample size determination and analysis plan	Work pm review of literature or study proposal
9:00-10:00	Introduction to EBM	Writing Center	Discussion of article critique assignment
10:00-11:00	Develop a searchable clinical or research question	Introduction to GCRC Bioinformatics Services	Visit off-campus sites participating in research	Preparing the research budget
11:00-12:00		Intro to Clinical Epidemiology
12:00-1:00	Lunch	Lunch	Lunch	Lunch
1:00-2:00	Format for performing systematic review of the literature	Epi continued	Developing the measurement model for systematic review or meta-analysis or research study	Critique assignment Select participants will present a critique of an assigned article and lead the discussion from 1 to 5 PM
2:00-3:00	Begin searching the literature	Online exercises on research designs
3:00-4:00			Attend GAC meeting (3rd Wednesday of the month)

Week 3: Protection of human subjects

Time	Monday	Tuesday	Wednesday	Thursday	Friday
8:00-9:00	Overview of human subjects concerns	Health literacy and cultural perspectives	Bioethics presentation	Data safety and monitoring	Work on projects
9:00-10:00		Health literacy continued
10:00-11:00	Elements of informed consent		Attend a bioethics committee meeting	State and federal laws pertaining to animal studies
11:00-12:00		Create an informed consent and HIPAA document	Ethical issues involving tissue/biological samples	Diversity training
12:00-1:00	Lunch	Lunch	Lunch	Lunch
1:00-2:00	Ethical considerations in the conduct of human research	Observe the consenting process for English and non-English speaking subjects, both for adult and pediatric studies	Talk to basic science researchers involved with genetics studies	Critique assignment Select participants will present a critique of an assigned article and lead the discussion

Week 4: Regulatory guidelines

Time	Monday	Tuesday	Wednesday	Thursday	Friday
8:00-9:00	Standard operating procedures	Maintaining regulatory documents	Introduction to the research proposal review process	Prepare for journal club	Work on projects
9:00-10:00	Investigator brochure	Industry-sponsored studies	PHS-398 Writing a grant application
10:00-11:00	Adverse events, serious adverse events, reporting and tracking	Observe activities of research-sponsored monitor		Journal Club: Critique and Discuss Article
11:00-12:00
12:00-1:00	Lunch	Lunch	Lunch
1:00-2:00	Investigational drug/device issues	Meet with Drug Discovery committee	Attend IRB review session
2:00-3:00	Source documents Case report forms

Week 5: Manage a research study/project

Time	Monday	Tuesday	Wednesday	Thursday	Friday
8:00-9:00	Data management systems	Submit an IRB application	Effective strategies for managing research team or writing groups	NIH study sections and the review process	Work on projects
9:00-10:00
10:00-11:00	Online exercise for entering and analyzing a small data set	Tools for monitoring compliance: focused audits, monitoring, safety reviews	Roles of study coordinator	Advertisement regulations
11:00-12:00
12:00-1:00	Lunch	Lunch	Lunch	Lunch
1:00-2:00	Journal club	Maintaining research fidelity	Study recruitment	Journal club

Week 6: Communication of findings

Time	Monday	Tuesday	Wednesday	Thursday	Friday
8:00-9:00		Student presentations	Student presentations	Student presentations	Student presentations
9:00-10:00
10:00-11:00
11:00-12:00		Review/critique	Review/critique	Review/critique	Review/critique
12:00-1:00	Lunch	Lunch	Lunch	Lunch	Lunch
1:00-2:00	Begin student presentations				Course evaluation