Intensive
Introductory Program
July/August
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
September-December
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
September-April
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
September-December
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
January-April
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
September-December
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.
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