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Course Descriptions (2009-2010)

The curriculum during Year 1 is devoted mainly to didactic coursework. At this time the student begins the pursuit of a mentor-based clinical research project. In Year 2 the trainee participates in a course in management skills at Harvard Business School. The second-year effort is focused on the clinical research project. At the conclusion of the program, the student submits a thesis, which can take the form of either a traditional master’s thesis or two research papers of publishable quality on which the student is first author.

Intensive Introductory Program
Monday through Friday

This course consists of three segments: Introduction to Biostatistics, Introduction to Clinical Epidemiology, and Introduction to Human Investigation. Both Introduction to Biostatistics and Introduction to Clinical Epidemiology are ongoing courses at the Harvard School of Public Health. The biostatistics course is modified to allow Scholars students to choose from among three focused "tracks" of study in the second half of the course.

Introduction to Biostatistics
John Orav
Kerrie Nelson

Provides a detailed introduction to the theory and application of statistical techniques that are commonly used in clinical research. Topics include: probability distribution, significant testing, confidence intervals, sample size calculation and power, measures of association, stratification in matched analysis, T tests, nonparametric analysis, analysis of variance, correlations and linear regressions. By the end of the course, students should be able to conduct all of the basic statistical tests, recognize the assumptions behind their analysis, and identify the multivariant models that could be used. This course is held at the Harvard School of Public Health.

Introduction to Clinical Epidemiology
E. Francis Cook
J. Katz
D. Singer

H. Baer

Addresses the design, implementation, analysis, and interpretation of clinical research projects, including cohort, case-control, and experimental studies. This course covers instruments to measure various dimensions of health, techniques to measure the reliability and validity of these instruments, common types of biases that occur in clinical research, methods for identifying and controlling for confounding, common analytic strategies, questionnaire design, "grantsmanship," and manuscript preparation. This course is held at the Harvard School of Public Health.

Introduction to Human Investigation
Munish Gupta
Jonathan Williams

The course consists of a series of separate but related modules—(1) introduction to clinical research, (2) the Institutional Review Board (IRB) process, (3) introductory human genetics, and (4) bioinformatics. Broad issues relative to research in human subjects cover the applicability of various methodologies in addressing specific physiologic questions and the role of institutional review boards. The genetics component consists of introductory lectures, tutorials, and journal clubs to address basic principles of human genetics including population genetics, genotyping, linkage analysis, analysis of complex traits, and pharmacogenetics. The bioinformatics component covers accession and manipulation of private and public databases, computational analysis, and computational techniques in functional genomics. This course is held in the Medical Education Center (Tosteson Building) at the Harvard Medical School.

Biostatistics 213
John Orav

This course introduces students involved in clinical research to the practical application of regression analyses. Linear regression, logistic regression, and proportional hazards survival models are covered, as well as general concepts in model selection, goodness-of-fit, and testing procedures. Each lecture is accompanied by a data analysis using SAS and a classroom discussion of the results. The course introduces but does not attempt to develop the underlying likelihood theory and uses as little calculus as possible. Upon completion of the course, the student should be able to carry out his/her own multiple linear and logistic regression analyses and will have had an introduction to Cox regression as well.

Longitudinal Clinical Research Seminar / Bioethics
Jonathan Williams
Munish Gupta

This course is designed to provide the opportunity for close interactions with faculty from a variety of clinical research disciplines. The goals of the course are to (1) provide students with practical information from a variety of areas relevant to patient-oriented research, (2) encourage students to apply and refine concepts learned to their ongoing clinical research projects, (3) foster the development of critical thinking in the art and science of clinical investigation, and (4) sharpen skills in the development and conduct of patient-oriented research and in the presentation of research findings. The first eight-week period of the fall semester consists of a bioethics curriculum for all first-year students co-directed by Robert Truog and Dan Brock. A mock study section, which allows students to review grant applications, is conducted in the spring semester.

Genetics in Clinical Investigation
Benjamin Raby


The success of the Human Genome Project has placed powerful tools in the hands of clinical investigators, offering an opportunity to explore the roles of genes in the pathogenesis of both rare and common disorders, eventually leading to the development of new approaches to diagnosis, prevention, and treatment. The primary goals of the course are to teach clinical researchers to (1) recognize opportunities to address genetic questions in clinical investigation, (2) appreciate the major approaches to research in genetics, and (3) understand the basics of study design and data analysis. Students will become familiar with how the genetic contribution to a phenotype can be recognized, basic principles of population genetics, technical approaches to genotypic analysis, identification of genes and mutations and use of genetic testing, use of computer databases in genomic research, principles of ethical conduct of genetics research, parametric and non-parametric linkage analysis, association analysis, studies of gene expression, principles of pharmacogenetics, and integration of genetics into medical practice. This course is held in the Medical Education Center (Tosteson Building) at the Harvard Medical School.

Translational Pharmacology
David Golan and Donald Coen
First two weeks of January

This course serves as a basic course in clinical pharmacology with application to clinical and translational research. Drug discovery, unmet clinical needs, pre-clinical development, clinical investigation, and manufacturing and regulatory issues are considered, with applications to diseases including cancer, diabetes, and AIDS. The course covers an intensive two-week period wherein lectures, invited speakers, case studies, problem sets, journal clubs, and group projects represent the principal teaching modalities. Case studies presented by industry executives provide a hands-on approach to how pharmaceuticals are developed in the real world and to ethical issues relative to the industry. Problem sets are designed to reinforce basic concepts and quantitative aspects, and journal clubs are designed to promote critical, close reading of the drug case studies and development literature. Facilitated group projects afford students the opportunity to work in teams in a collaborative environment that reflects the manner in which drugs are currently designed. The first third of the course provides students with basic pharmacological principles and concepts and their molecular underpinnings. The second third of the course teaches modern methods to discover and design new drugs. The last third explores pharmaceutical industry issues, pharmacoeconomics, and pharmacovigilance. This course is held in the Longwood Medical Area.

Fundamental Methods of Clinical Trials
Donald Cutlip

The scope of research in human health and disease ranges from observational and epidemiological studies (of small case series to large populations), to outcomes and health services research, to prospectively controlled studies of isolated medical interventions (clinical trials). The conduct and execution of clinical trials are complex and require the integration of a broad spectrum of experts in clinical and basic science medicine, biostatistics, bioethics, data and operations management, technology development, and government regulation. This course will provide the fundamental knowledge-base and practicum experience to equip the clinical investigator with the tools necessary to function as an effective team member in the design and conduct of ethically-sound clinical trials. By further integrating acquired basic biostatistical and epidemiological principles, the clinical investigator will achieve the skill set needed to critically review clinical trials designs and results, to know when to apply alternative treatment allocation schemes or group sequential designs, and to understand the strengths and limitations of a wide variety of post-hoc analyses and meta-analytical techniques. This course is held in the Medical Education Center (Tosteson Building) at the Harvard Medical School.

Inventing Breakthroughs and Commercializing Science
Vicki Sato
Harvard Business School

How do scientists take their research to the marketplace? What is the difference between "open science" and "proprietary technology" and what are the implications for commercialization of both? How does one manage cross-disciplinary teams of scientists, engineers, and MBAs? Commercializing Science and High Technology tackles these issues and applies learning on projects drawn from Harvard labs and local high-tech firms. The underlying theme of the course focuses on innovating across boundaries. While creative breakthroughs can potentially happen anywhere, they are more likely, and more risky, when innovators cross boundaries. We learn how to bridge technological, professional, organizational, and institutional boundaries by crossing boundaries ourselves. Approximately half the class consists of Harvard MBAs and the other half is a select group of science, engineering, and medical students. The course aims to give the student an understanding of today's increasingly complex innovative landscape, where one needs to be comfortable with the strategic, operational, and ethical issues that arise on such a landscape. In addition, the course project provides hands-on experience, with cross-disciplinary teams, in the development of science and leading edge technologies such as genomics, nanotechnology, information technology, and photonics. Students are allowed to pursue their own project ideas as long as they fit within the scope of the course.

Elective Courses

Although the current curriculum of required courses and the mentored clinical research project reflect a full course load for most Scholars, some students choose to take one or more electives—courses into which they may cross register without incurring additional fees. If a student wishes to take an elective course for credit, s/he should keep in mind that the course must be passed with a satisfactory grade in order for the student to receive a diploma from Harvard. Only elective courses that do not interfere with the schedule of required courses are eligible to be taken by Scholars.

The courses listed below have been recommended by previous students but represent just a sampling of available electives. Please note that these courses may not be offered every year and that some of the information provided (e.g., name of course directors) may no longer be valid:

BIO 226 – Longitudinal Analysis
Harvard School of Public Health
James Ware

This course teaches methods of analysis for longitudinal data (repeated measures) using linear and longitudinal regression. Although repeated measures ANOVA might be enough for most students’ needs, some datasets (even those with small sample sizes) require other methods of analysis which are covered in this course. The course is well taught and provides important skills for clinical researchers who use repeated measures analysis in their work. The instructor is excellent, and homework and assignments are not too burdensome. The course is not heavy on mathematics and is very suitable for Scholars students. However, certain parts of the course deal with somewhat advanced biostatistics topics.

BIO 223 – Applied Survival Analysis and Discrete Data Analysis
Harvard School of Public Health
E. Goetghebeur, E. A. Houseman

The first half of the course covers discrete data analysis, and the second part is dedicated to survival analysis. The course imparts important statistical skills but is heavy on mathematics and theory, quite a bit more so than required for clinical application. The material supplements the BIO 213 regression course. Not recommended for most Scholars students unless the material/skills are important for their research.

EPI 233 – Research Synthesis and Meta-analysis
Harvard School of Public Health
Simin Liu

This course covers the basics necessary to perform a meta-analysis. Although the theory may be overwhelming in the beginning, the course is very practical and imparts a useful analytic skill. It is recommended for those who think that they may use meta-analysis techniques in their research. Those taking the course should have a specific question/project in mind to which meta-analysis can be applied.

EPI 271 – Propensity Score Analysis: Theoretical and Practical Considerations
Harvard School of Public Health
T. Kurth, J. D. Seeger

This course introduces the theory and practical aspects of propensity scores. The course is very practical and directed toward clinicians. It is especially important for clinicians who work with large datasets from observational studies. There are few assignments, so most of the time dedicated to the course is spent as in-class activities (labs and lectures).

RDS 280 – Decision Analysis in Health Care
Harvard School of Public Health
Sue Goldie

This course is an interesting and well-taught one, providing a good introduction to the topic. However, it would be difficult to apply decision analysis methods without taking more advanced courses in the field. It is recommended only to students who have an interest in the topic. Homework assignments can be time-consuming.

PAL-120M – Introduction to Leadership
Kennedy School of Government
Professor Joseph S. Nye

This course, audited by Scholars students in the past, teaches the basic tools of effective leadership and is reported to be a gratifying experience. The instructor, a past dean of the Kennedy School, is excellent. While the course is recommended, it is not necessarily the best leadership course for Scholars students because its focus is on political leadership. Because the course was not taken for credit, information on requirements for credit is not available.