Medical Epidemiology

This course emphasizes epidemiologic principles in the context of clinical populations and associated clinical research design and conduct. The text for the course is Designing Clinical Research (2^nd ed.) by Stephen B. Hulley, et.al.  (Lippincott Williams & Wilkins).

There are 7 weekly meetings early in the first year of CSTP training. The class sessions consist of approximately 1 hour of didactic lecture associated with assigned reading. The remainder of the session is a class discussion focused on practical application of the session material to specific clinical research situations identified by the instructor and students. Students are also encouraged to complete the exercises at the end of each assigned textbook chapter, and these exercises may also form the basis for class discussion. .

Biostatistics I

Technical and scientific literature in the health and life sciences has become increasingly quantitative and Bio- statistics is at the core of biomedical research.  This course emphasizes a problem solving, hands-on computer oriented approach.  Its primary objectives are to provide a broad introduction to fundamental bio statistical concepts and procedures.  Most of the material relates to the design, analysis, and interpretation of epidemiologic, clinical, and laboratory studies.  The following types of problems are discussed: 1. Examination, summarization, and presentation (both graphically and numerically) of results in a single sample of counts or measurements.  2. Comparisons of two or more samples.  3. Association of variables, including two-way cross classifications.  After completing these courses, students should be able to:

1. Understand the very basic role of statistics in research.
2. Select appropriate statistical methods for most data sets.
3. Demonstrate an understanding of the logical foundation for commonly used basic statistical inferential procedures.
4. Perform basic statistical analyses commonly used in biomedical investigations. 
5. Use at least one of the most commonly available statistical packages, such as NCSS or STATISTIX, to perform basic statistical analyses, and interpret computer outputs for many commonly used statistical procedures.
6. Evaluate most statistical analyses reported in the medical and health care literature.

Advanced Biostatistics II

This course is a continuation of Biostatistics I and covers four topics of fundamental importance in epidemiology and clinical research: Simple and Multiple Linear Regression, Simple and Multiple Logistic Regression, and Survival Analysis including Kaplan-Meier methods and Cox Regression.

As the 1^st Semester course, this course emphasizes a problem solving, hands-on computer oriented approach and its primary objective is to familiarize the students with the use of the techniques used in the analysis of the above topics, as well as the proper presentation and interpretation of the results.  After completing the course, students should be able to:

1. Understand the principles underlying each of the methods presented.
2. Select the appropriate statistical method for analysis of a given data set.
3. Use at least one of the most commonly available statistical packages, such as NCSS or STATISTIX, to perform basic bivariate and multivariate linear and logistic regression analyses, as well as survival analyses.
4. Interpret computer outputs for the statistical techniques covered in the course.
5. Evaluate results of statistical analyses reported in the medical and health care literature on bivariate and multivariate linear and logistic regression analyses, as well as survival analyses.

Critical Reading of the Research Literature

Overview: The purpose of this course is to provide participants with the skills necessary to efficiently access research information and critically evaluate it in the preparation of clinical research studies.

Goals:

In order to develop new and meaningful clinical studies, researchers must be able to locate relevant information about others’ work and evaluate it.  Researchers must thus be familiar with computerized databases and effective strategies for extracting information from them.  They must be familiar with typical research designs used in clinical research, the statistical techniques commonly used in each, and be able to evaluate the appropriateness of research methodology.  Researchers must be able to critically read results and discussion sections of research reports to evaluate the appropriateness of authors’ conclusions and to become able to identify gaps in current research that may yield meaningful follow-up research.

Course text: Greenhalgh T: How to read a paper.  London: BMJ Books, 2001.

Specific objectives:

At the conclusion of this course, participants will be able to:

1)      Identify at least two computer-based bibliographic databases and at least one method for accessing each;

2)      Identify key differences between cohort, case control, and randomized trials;

3)      Explain the rationale for the use of placebos and randomization in clinical research;

4)      Given a research study in the participant’s field of interest, identify threats to validity (e.g., manner of participant recruitment or selection, randomization, or bias in application of treatments);

5)      Determine whether an author’s conclusions are consistent with data presented;

6)      Differentiate between relevant discussion and speculation in the discussion section of a manuscript;

7)      After reading an article in his or her area of interest, state an idea for at least one follow-up study that would extend the article’s results; and

8)      State at least one element that should be present in each of the sections of a typical research paper (in each of the abstract, introduction, methods, results, and discussion sections).

Grantsmanship

The Grantsmanship course has been organized to fit into a six week timeframe.  Each class introduces a new section(s) of an R01 level application using the PHS 398 format.  The purpose of the course is to formally review the grant writing process, covering each section of the grant in sufficient detail.  It also requires that trainees write their own “practice” application that is subsequently reviewed by the participating faculty in a manner similar to that used by federal funding agencies.  The trainees also have the opportunity to witness the mock review of an application to familiarize themselves with the process. 

Objectives:

By the end of the six-week module, the participants will have prepared a draft of an application for grant support in the format of the NIH.  This product will reflect the participants’ learning of basic principles for constructing a grant application, including focus on the scientific contribution of the proposed research, framing of aims in terms of scientific payoffs, appropriate inclusion of preliminary studies, and thorough specification of methods.  Faculty will provide feedback for each proposal with the eventual goal of preparing it for submission to a funding agency.

Behavioral Issues in Clinical Research

Consistent with the increasing recognition of the importance of behavioral factors in the production and treatment of disease as well as in the management of clinical research, our curriculum includes a course on behavioral factors in disease.  This course provides fellows with basic information on behavioral risk factors for disease and the role of behavioral interventions in clinical research (e.g., changing diet and increasing exercise in the control of hypertension).  Lectures focus on theories of behavior change and learning as the basis for the design of interventions. This base provides needed background to understand how to design interventions to change research participants’ behavior.

Other topics covered in this course include issues related to the management of clinical research and multicenter clinical trials, including the role and responsibility of the principal investigator and an overview of management issues related to contracts, budgeting, and supervision of research staff.  The course includes presentations on recruitment and retention of participants in clinical research, including the importance of recruitment of minority participants.  Strategies for promoting retention will be discussed and methods to promote adherence to research protocols will be presented.

Overall goals for the course:

The goals for this course will be to acquaint fellows with the importance of behavioral factors in disease and the potential role of behavioral interventions in affecting disease course.  Additional goals will be to acquaint participants with management issues related to clinical research and to provide them with specific information about the problems of recruitment, retention, and adherence in clinical research.

Specific objectives for the course:

At the conclusion of this course, participants will be able to:

1. List three modifiable risk factors for various diseases and describe their importance for studies of disease prevalence and treatment;
2. State key characteristics of classical conditioning and instrumental learning and provide one example of behavior change strategies based on each.
3. List cognitive prerequisites for behavioral change, list techniques to enhance patients’ readiness for change, and explain how these may affect the design and outcomes of treatment studies; and
4. Describe typical patterns of patient nonadherence to treatment regimens, list several techniques for enhancing patients’ adherence, and develop a plan for dealing with nonadherence in treatment studies.

The course consists of 3 lectures taught over 3 weeks. 

Ethics

The “standard of care” for training clinician-scientists has changed, for the better. It is now universally recognized that science alone is inadequate to the task, and that a comprehensive training program must include instruction in and opportunities to discuss and debate ethical and social issues related to research. These issues tend to fall under two main headings: research integrity or the responsible conduct of research and human subjects protection. The former emphasize issues such as data management, conflicts of interests, publication and authorship and the like; the latter focus on valid consent, privacy and confidentiality, questions related to the concept of “acceptable risk” and others. It is our position that the two domains are actually linked in ways too often overlooked.

Ethics education will be threaded through the entire curriculum, better to underscore the breadth and utility of the kinds of conceptual skills that applied ethics brings to bear in clinical research. Hence, ethical issues will be addressed during parts of the curriculum devoted to research design, epidemiology, genetics, statistics and others, as appropriate. These ethics modules will focus on valid consent for research, challenges in obtaining consent in community contexts, the need to evaluate risk against a background of social and individual benefit, and the core issues related to the responsible conduct of research.

Experts in bioethics and IRB process from around the country developed the Collaborative IRB Training Initiative (CITI) program, hosted and coordinated at the University of Miami.  The CITI human subjects research educational program consists of 13 Parts each focused on a different aspect of bio-ethics and human subjects research. Each Part, developed by experts in the "IRB community" has an associated quiz. The software maintained at the University of Miami, compiles the quiz scores.  Our trainees are required to complete and pass this course.

Throughout, while our Ethics Module aims to promote scientific integrity, and so will address examples of frank wrongdoing, it is acknowledged that modern scientific research raises questions on which reasonable people disagree. One of the goals of the module is therefore to provide a conceptual or analytical framework for critical decision making. The motivation for this approach is that ethical problems arise in a wide variety of circumstances and it is not feasible to review or predict all of them; introducing an analytical framework arguably provides students with some of the tools necessary for evaluating different and novel kinds of problems as they arise; and this best prepares students to meet future challenges to scientific integrity.

In addition to the formal ethics lectures, trainees are expected to attend “Dialogues in Research Ethics”.  “Dialogues” is a luncheon series sponsored by UM Bioethics that provides faculty, students, and staff frequent discussions on pertinent medical ethics topics. Trainees are expected to attend these sessions.  A listing of the topics from 2001 to present can be found in Appendix IV. 

Research in Multicultural Populations

Clinical Instructions in Cultural Context– This module gives students a background in how to approach study participants who may have very different approaches to Western Biomedicine than college educated white non-Hispanics.  Upon completion of this module, the students will be able to identify resources for solving specific problems of a cultural nature, anticipate problems in communicating instructions, and develop plans for addressing those problems. Such instances occur frequently in Miami where the population is diverse and the majority of the population Hispanic.

HIV and Culture– HIV testing, management of HIV patients, and questions of adherence to clinical regimens receive attention in this module, with a focus on cultural aspects of these activities.  Students completing the module will be able to describe key issues in recruitment and maintenance of culturally distinct populations in clinical trials.

Drugs and Culture– The core leader’s considerable experience in research on the consequences of street drug use forms the basis for this module, in which students learn about intercultural variation in use patterns, rigorous characterization of medical outcomes of drug use, and design of studies for future investigation.

Participants Live in Cultural Context– This module emphasizes the value of developing “natural habitat” perspective on the behavior of study participants.  Students completing this module will be able to list the advantages of observing behavior of study participants in natural habitat and using their observations to improve interventions.

Molecular Biology & Genetics, Cell Biology/Biochemistry

The Molecular and Cell Biology Core courses for the Clinical Scientist Training Program were designed to succinctly review the topics in each of these fields most relevant to a career in biomedical research, providing a solid foundation on which individual interests and knowledge could be enhanced an strengthened. These courses build on previous experience and strengths in research and teaching within our institution.  Key medical school faculties, therefore, have been chosen to participate in these courses. The course consists of 6 lectures taught over 6 weeks.

The content of these courses was decided by an advisory committee of individuals who have considerable experience in coordinating and teaching similar graduate and post-graduate courses on campus, as well as from feedback received from the CSTP trainees.  Thus, considerable thought has been placed into the content and organization of these modules.  Instructors are asked to emphasize the following points within their individual lectures: integration of basic and advanced knowledge to applications in clinical research; paradigms of human disease; practical applications of selected methodologies, local (university) examples/models of particular pertinent research investigations, and ethical issues.  The applicability of this information is integrated into several penultimate lectures at the end of each module.  In the Molecular Biology/Molecular Genetics core, the last two lectures focus on gene therapy (featuring a speaker of national recognition), and a panel of medical school faculty who are actively spearheading translational research projects.  In the Cell Biology/Biochemistry Core, the last two lectures focus on highly complex and relevant topics- Cancer Biology and Cell Cycle/Apoptosis. 

The faculty members giving these lectures are nationally-funded and recognized as leaders in their respective fields, as well as active participants in translational research in these areas.  It is anticipated that at the completion of these modules, trainees will be poised to address more advanced related topics, as well as enter into a laboratory setting, using the information and knowledge gained from these core courses. 

Orientation

Each summer, the CSTP hosts an “Introduction to Clinical Research”.  The Program uses this to present the CSTP to the University Fellows and Faculty, and to give an overview of various aspects of Clinical Research.  The topics covered include:  An introduction from Dean John Clarkson, an overview of the types of careers available in Academic Medicine, an overview of Epidemiology, a discussion on mentorship, why it’s important, and how to choose a mentor, an introduction to the CSTP, and a panel of Fellows, Junior faculty and Senior faculty who discuss why they chose a career in clinical research. This has been an invaluable way to introduce the CSTP to a broad audience, inform them of the courses, and emphasize the importance of clinical research in medicine.