I. Background and Overview of Program
The Harvard Medical School Master of Medical Sciences in Clinical Investigation (MMSCI) program provides training in the methods and conduct of clinical and translational investigation for future leaders in patient-oriented research. This two-year degree program combines innovative forms of pedagogy from leading Harvard faculty with an individual mentored research experience in a Harvard Medical Schoolaffiliated laboratory
Mission Statement and Goals
MMSCI provides outstanding didactic and mentored-research training to early career clinical and translational investigators to prepare them for leadership roles in patient-oriented research.
The major goal of the program is to provide an innovative comprehensive curriculum that allows trainees to develop skills and direct experience in the performance of clinical and translational investigation while simultaneously, through didactic course work, providing them with a strong foundation in the tools and techniques required to be successful clinical and translational investigators.
Program Objectives
1. To provide a strong didactic curriculum that includes training in computational and statistical sciences, epidemiology and study design, biomedical ethics, genetic epidemiology, scientific communication, drug development and safety, statistical programming, leadership, and management in clinical research
2. To enable students to conduct clinical and translational research with an HMS faculty member mentor
3. To provide students with the core skills necessary to write successful grant applications that will help them initiate research careers as independent investigators
Upon completion of the program, graduates will be able to apply contemporary research tools to clinically relevant areas of investigation and be highly competitive for careers in patient -oriented research in academic medicine, industry, and regulatory affairs.
Program Outline / Courses
The program in Clinical Investigation and Translational Investigation is organized as follows:
1. Mentored Research Experience: The core feature of the MMSCI program is the mentored research experience in a Harvard-affiliated research group. During the two years of the program, each student is required to develop and execute research projects under the guidance of a primary mentor and a dedicated thesis committee.
2. Intensive workshops: The central pillars of the MMSCI program consist of intensive workshops and didactic sessions that are complemented by journal clubs, office hours, computer laboratory classes, team-based projects, and presentations.
3. Longitudinal teaching: Between each workshop, further exploration of contemporary research topics will occur at weekly interactive sessions. Novel pedagogic approaches for this longitudinal series include the use of flipped classroom methods, where students review and dissect learning material in advance of facilitated discussions.
4. Scientific Communication: This course is designed to complement the didactic and longitudinal curricula through team-based database analysis: presenting the data in figures and tables in various formats (poster, short presentation, and a research presentation) as well as state-of-the-art talks.
5. Individualized Learning: Opportunities for customized learning include two tracks: one in translational investigation and the other in clinical investigation, with the clinical investigation track containing individual pathways in clinical trials and comparative research. Elective course
opportunities at HMS and other Harvard schools are available with the permission of the Program Director
II. Degree(s) Offered
The Master of Medical Sciences (MMSc) degree in Clinical Investigation is offered. This is a 66.5-69.5credit two-year full-time or three-year low residency program that consists of academic training, mentored research training, team-based projects and career-development activities.
III. Prerequisites for Admission
Applicants must hold an MD, MBBS, or an equivalent doctoral degree and be pursuing research in clinical disciplines. Applicants in clinical training programs must have no more than 25% effort allocated to nonacademic activities during the two-year period. On a case-by-case basis, the program will consider candidates with a PhD degree for admission.
In addition to the requirements listed above, a language proficiency test is required for applicants for whom English was not the medium of instruction for their undergraduate or graduate degree. The master’s programs accept TOEFL iBT, TOEFL Essentials, IELTS Academic, or the Duolingo English Test.
To be considered for admission, applicants must meet the following minimum test score requirements: TOEFL iBT: 103
TOEFL Essentials: 11
IELTS Academic: 7.5
Duolingo English Test: 130
Instructions to submit official test scores: TOEFL iBT and TOEFL Essentials: Code 3151: Harvard Medical School Graduate Education Master’s Programs
IELTS Academic: Contact the test center where you took the IELTS test to request that your scores be sent via E-Delivery to:
Account Name: Harvard Medical School Graduate Education Master's Programs Address: Graduate Education Master's Programs 25 Shattuck Street Boston, MA 02115 United States
Duolingo English Test: Search for “Harvard Medical School” and select the appropriate program.
IV. Academic Residence Requirements
The MMSCI requires that all didactic coursework and mentored research take place on Harvard’s campus (HMS or other Harvard Schools) or at an HMS-affiliated hospital.
V. Course of Study
A. Concentrations offered
The program is divided into two tracks that outline the student’s coursework over the program length The program contains a translational investigation (TI) track and a clinical investigation (CI) track. The CI track has two pathways, one in Clinical Trials and one in Comparative Research. The figures below outline the program curricular map including all concentrations offered in the traditional 2-year format.
a. Master of Medical Sciences in Clinical Investigation 2-year Program
The program has traditionally been offered in a 2-year format with a progressive scaffolding of coursework and mentored research experience. The image below outlines the 2-year program courses across all tracks and pathways.
b. Clinical Investigation Track Curriculum Map
This track is co-led by Finnian R. Mc Causland and Ajay K. Singh, who both have extensive experience in observational research and clinical trials. The clinical investigation track allows customized learning for students through the pursuit of either a comparative research pathway or a clinical trials pathway. Guided by a dedicated thesis committee, each student completes two first-author manuscripts based on the work from their individual research projects.
c. Translational Investigation Track Curriculum Map
The translational investigation track was created to fill an unmet need to provide training for individuals pursuing a career in basic and/or translational research (i.e. in the T0 to T2 spectrum of translational investigation). Incorporating the translational track within the MMSCI program is consistent with our overall goal to train future global leaders in clinical and translational research. Broadening of the MMSCI program to incorporate these additional students will ensure diversity of experience, skills, and ideas, while promoting collaboration across the spectrum of clinical and translational research.
B. Curriculum by term, 2-year program
The 2-year program begins in July of the first year, with the first intensive workshop, and ends in May of the second year, with the awarding of the degree following the final workshop. The list below shows all the courses in the program listed by term.
Master of Medical Sciences in Clinical Investigation Courses
Color Key for this table:
COR: Core Foundational courses common to all tracks and pathways
CI: Clinical Investigation Track courses common to all CI pathways
CT: Clinical Trials Pathway courses only for CT pathway
CR: Comparative Research Pathway courses only for CR pathway
TI: Translational Investigation Track courses
Year I
Workshop 1 (July)
COR CI742: Fundamental Skills for Academic Success (1 cr)
COR CI701: Clinical Data Science: Design and Analytics I (3 cr)
COR CI700: Ethics and the IRB (1 cr)
Fall Longitudinal Courses (September to December)
COR CI706: Mentored Research Experience(10 cr)
COR CI704A: Scientific Communication (1 cr)
COR CI708A: Clinical Data Science: Design and Analytics II (1.5 cr)
COR CI709A: Intro to Clinical and Translational Thesis Preparation (1 cr)
CI CI702A: Clinical Trials Part 1 (1.5 cr)
TI CI760: Investigative Models for Translational Research (1 cr)
Workshop 2 January Term (January)
TI (optional for CI) CI 716: R Workshop (1 cr)
Spring Longitudinal Courses (January to April)
COR CI706: Mentored Research Experience(10 cr)
COR CI704B: Scientific Communication (1 cr)
COR CI708B: Clinical Data Science: Design and Analytics II (1.5 cr)
COR CI724: Genetic Epidemiology (2 cr)
CI CI702B: Clinical Trials Part 2 (1.5 cr)
TI CI 764A: System Biology & Omics Analysis (2 cr)
Workshop 3 (April - May)
CR CI 722: Comparative Effectiveness Research I (3 cr)
TI CI 762: Cell and Molecular Biology (2 cr)
Year II
Workshop 4 (September)
CT (optional for TI) CI 710: Special Topics in Drug Development and Evaluation (2 cr)
Fall Longitudinal Courses (September to December)
COR CI706: Mentored Research Experience(10 Cr)
COR CI714A: Scientific Communication (1 cr)
COR CI709B: Clinical and Translational Investigation Thesis Preparation (2 cr)
CT CI726A: Advanced Topics in Clinical Trials A (2 cr)
CR CI 732A: Comparative Effectiveness Research II (1.5 cr)
TI CI 764B: System Biology & Omics Analysis (2 cr)
Workshop 5 (January)
COR CI740: Leadership and Teamwork (2 cr)
Optional Elective: BCMP301QC: Translational Pharmacology (2 cr)
Spring Longitudinal Courses (January - May)
COR CI706: Mentored Research Experience (10 cr)
COR CI714B: Scientific Communication (1 cr)
CT CI726B: Advanced Topics in Clinical Trials B (2 cr)
CR CI 732B: Comparative Effectiveness Research II (1.5cr)
TI CI 766: Translating Innovation into Practice (1 cr)
C. Curriculum by term, 3-year program
A three-year option is being offered to eligible candidates who receive approval from the program leadership. The figures below illustrate the distribution of the same 66.5-69.5 credits and courses over a 3year period for all the program offerings.
Master of Medical Sciences in Clinical Investigation Courses in 3-year program
Color Key for this table:
COR: Core Foundational courses common to all tracks and pathways
CI: Clinical Investigation Track courses common to all CI pathways
CT: Clinical Trials Pathway courses only for CT pathway
CR: Comparative Research Pathway courses only for CR pathway
TI: Translational Investigation Track courses
Year I
Workshop 1 (July)
COR CI742: Fundamental Skills for Academic Success (1 cr)
COR CI701: Clinical Data Science: Design and Analytics I (3 cr)
COR CI700: Ethics and the IRB (1 cr)
Fall Longitudinal Courses (September to December)
COR CI706: Mentored Research Experience (5 cr)
COR CI704A: Scientific Communication (1 cr)
COR CI708A: Clinical Data Science: Design and Analytics II (1.5 cr)
COR CI709A: Intro to Clinical and Translational Thesis Preparation (1 cr)
CI CI702A: Clinical Trials Part 1 (1.5 cr)
TI CI760: Investigative Models for Translational Research (1 cr)
Workshop 2 - January Term (January)
COR CI740: Leadership and Teamwork (2 cr)
Spring Longitudinal Courses (January to April)
COR CI706: Mentored Research Experience (5 cr)
COR CI704B: Scientific Communication (1 cr)
COR CI708B: Clinical Data Science: Design and Analytics II (1.5 cr)
COR CI724: Genetic Epidemiology (2 cr)
CI CI702B: Clinical Trials Part 2(1.5 cr)
TI CI 764A: System Biology & Omics Analysis (2 cr)
Workshop 3 (April - May)
CR CI 722: Comparative Effectiveness Research I (3 cr)
TI CI 762: Cell and Molecular Biology (2 cr)
Year II
Workshop 4
CT (optional for TI) CI 710: Special Topics in Drug Development and Evaluation (2 cr)
Fall Longitudinal Courses (September to December)
COR CI706: Mentored Research Experience (5 cr)
COR CI714A: Scientific Communication (1 cr)
CT CI726A: Advanced Topics in Clinical Trials A (2 cr)
CR CI 732A: Comparative Effectiveness Research II (1.5 cr)
TI CI 764B: System Biology & Omics Analysis (2 cr)
Workshop 5 (January)
TI (optional for CI): CI 716: R Workshop (1 cr)
Optional Elective: BCMP301QC: Translational Pharmacology (2 cr)
Spring Longitudinal Courses (January - May)
COR CI706: Mentored Research Experience (5 cr)
COR CI714B: Scientific Communication (1 cr)
CT CI726B: Advanced Topics in Clinical Trials B (2 cr)
CR CI 732B: Comparative Effectiveness Research II (1.5 cr)
TI CI 766: Translating Innovation into Practice (1 cr)
Year III
Fall Longitudinal Courses (September to December)
COR CI706: Mentored Research Experience (10 cr)
COR CI709B: Clinical and Translational Investigation Thesis Preparation (2 cr)
Spring Longitudinal Courses (January - May)
COR CI706: Mentored Research Experience (10 cr)
VI. Description of all MMSCI Courses
Required Core Courses in all tracks and pathways
CI701: Clinical Data Science: Design and Analytics I
Course Directors: Elizabeth Mostofsky, Sc.D; Brian Claggett, PhD
Clinical research requires the generation and analysis of data for three tasks: description, prediction, and causal inference. This course introduces the methods to accomplish these tasks through seamless integration of materials usually taught separately in epidemiology and biostatistics courses. This course includes recorded and live lectures as well as interactive assignments to introduce students to core principles and concepts in epidemiology and biostatistics. The epidemiology component will introduce students to measures of frequency and association, epidemiologic study designs, and basic epidemiologic methods. The biostatistics component will introduce students to data types, data summaries, hypothesis testing, the essentials of statistical inference, and statistical methods for calculating summary estimates, measures of variability, confidence intervals, sample size calculations, and concepts for modeling. All methods are taught along with STATA software to implement them.
The course emphasizes critical thinking and practical applications, including online assignments and interactive case study discussions. This course is the first course in the sequence of core courses of the Master of Medical Sciences in Clinical Investigation. It is followed by the core course Clinical Data Science: Design and Analytics II.
CI742: Fundamental Skills for Academic Success
Course Director: Martina McGrath, MBBCh
This course is designed to share with students an overview of some of the key skill sets that will
support their experience as graduate students. We will review how adults learn better and why having a growth mindset is essential for graduate school and professional life. Students will analyze and discuss key challenges in professionalism (communication, respect, biases, academic honesty, etc.). Furthermore, we will focus on strengthening leadership and teamwork essential skills like perspective taking, contribution to group dynamics, and best practices when working in groups.
Building on organizational behavior and coaching principles, this course will also examine key aspects of leadership, time management as a graduate student and relationship building with a key focus on mentor-mentee relationships. Finally, students will evaluate their strengths and weaknesses in regard to professionalism, teamwork, and leadership, and develop a strategy to enhance their academic and professional performance.
CI700: Ethics and the Institutional Review Board
Course Directors: Susan Kornetsky, MPH, Pearl O’Rourke, MD, and Benjamin Silverman, MD
This course will examine the regulatory and ethical oversight of the history and evolution of ethical research codes and regulations. The role and responsibility of principal investigators will be discussed. The course will include the history of research ethics and touch upon the ethics of animal research which often is the precursor to trials in human beings. Information about how to prepare research protocol applications and informed consent documents for clinical research will be provided. The course will also review some current and common challenges in the ethical conduct of research including consideration of diversity and equity and inclusion, recruitment practices, vulnerable populations, and topics such as AI and machine learning, genomics, and use of social media in research. The importance of considering the perspectives of subjects and patients in clinical research will also be explored. The course will include didactic and group work that will emphasize critical thinking and practical application of ethical considerations while developing and implementing patient-oriented research.
CI704 (A&B): Scientific Communication Part I
Course Directors: Martina McGrath, MBBCh, Youssef Farag MD, MPH, PhD
The ability to clearly articulate scientific ideas and communicate data is a core skill for any researcher. This is the first of a two-part course that is delivered longitudinally each year. Part I (year one) focuses on dissemination of scientific results, while Part II (in year two) focuses on grant preparation.
Specifically, the Part I course focuses on developing skills in formulating a research question, organizing and analyzing data, data visualization, and preparing and presenting data. Topics covered include presentation skills, developing a research talk, preparing a clinical and a translational research manuscript, and understanding the journal editorial process. In a longitudinal exercise in communicating science, students are given a teaching dataset (the SEEK India study) and work in teams to develop a r esearch question, perform the analysis and present their study in both poster and oral presentation forms, with extensive faculty feedback.
Part I culminates with the annual MMSCI Research Day, where Year 1 students are required to present a formal poster based on their ongoing work, while year 2 students are required to present an oral presentation to a faculty panel.
CI714 (A&B): Scientific Communication Part II
Course Directors: Rosalyn Adam, PhD and Enid Martinez, MD
This course will have discussion sessions on topics relevant to grant writing in clinical and translational research. The overarching goal will be to provide an interactive opportunity for discussion on topics that cover the key areas for investigators seeking funding in clinical and translational research. At the end of the course, there will be an MMSCI Research Day. The Year 1 students will present a poster and the Year II students will give a 10-minute oral presentation based on the research projects with their mentor.
CI708A: Clinical Data Science: Design and Analytics II
Course Director: Qiaoli Wang, MD, PhD
This course extends the topics introduced in Design and Analytics I and continues to integrate epidemiology and biostatistics with the goal of conducting well-designed, rigorous clinical research. All methods are taught along with Stata software to implement them. This course will cover several major areas relevant for clinical investigation: 1) Modeling approaches, including multivariable regression 2) Evidence synthesis using systematic reviews and meta-analyses, which lays the groundwork for identifying clinically significant research questions.
The course emphasizes critical thinking and practical applications. Students will complete a team project for this course: A publishable systematic review and meta-analysis paper. This is part A of the second course in the sequence of core courses for the Master of Medical Sciences in Clinical Investigation.
CI708B: Clinical Data Science: Design and Analytics II
Course Director: Qiaoli Wang, MD, PhD
This course extends the topics introduced in Design and Analytics II (part A) and further integrates key epidemiological concepts in clinical applications with the aim of performing high-quality clinical research. This course will cover 1) Evaluation of screening tests and risk prediction methods, and 2) Common biases in clinical research, presented through an epidemiologic as well as causal inference framework.
The course emphasizes critical thinking and practical applications. Students will complete a team project for this course: A screening test proposal. This is part B of the second course in the sequence of core courses for the Master of Medical Sciences in Clinical Investigation.
CI706: Mentored Research Experience
Course Director: Martina McGrath, MBBCh and Finnian Mc Causland, MBBCh, MMSc
All students undertaking the MMSCI degree are required to complete a thesis, as a culmination of the mentored research experience. The purpose of this requirement is two-fold, to highlight the importance of publishing quality research in peer-reviewed academic journals; and to promote excellence in the practice of scientific communication. The thesis requirement must be completed in a Harvard-affiliated research group under the direct supervision of the thesis committee that consists of the student, the primary mentor, one external content advisor and an MMSCI Program Representative. Please see section below for further details on the mentored research experience
CI 709A: Introduction to Clinical and Translational Thesis Preparation
Course Director: Finnian Mc Causland, MBBCh, MMSc and Kerri LaRovere, MD, RPNI, MMSc
During the course of the MMSCI program learners work with their mentors on two thematically linked research projects, which form the basis for two first-author publications or a body of work. The Clinical & Translational Investigation Thesis Preparation course provides guidance on topics critical to a successful mentored research experience, as well as focusing on the preparation and presentation of the written and oral forms of the thesis defense.
Year 1 topics include: Preparing for your thesis committee meetings; Preparing your thesis committee report; Individual Development Plan; Giving and receiving feedback; conflict in clinical research; Dealing with uncertainty; Time management
CI 709B: Clinical and Translational Thesis Preparation
Course Director: Finnian Mc Causland, MBBCh, MMSc and Kerri LaRovere, MD, RPNI, MMSc
During the course of the MMSCI program learners work with their mentors on two thematically linked research projects, which form the basis for two first-author publications or a body of work. The Clinical
& Translational Investigation Thesis Preparation course provides guidance on topics critical to a successful mentored research experience, as well as focusing on the preparation and presentation of the written and oral forms of the thesis defense.
Year 2 topics include: review of analytic strategies for qualitative and quantitative data; presenting skills for qualitative and quantitative data; writing an academic paper; writing an op-ed (opinion) piece for the popular press; tips for writing and grammar. Weekly writing advising allows students to receive continuous feedback on their thesis composition. In addition to academic advising from the program directors, thesis committee and other faculty, supplemental instruction in statistical programming is also available. This class will occur on Wednesdays from 8 – 10am throughout the fall semester.
CI 724: Genetic Epidemiology
Course Directors: Michael Cho, MD and Su Chu, PhD, M.S.
This course provides clinical researchers with the skills to thoughtfully incorporate genetic studies into their research programs and clinical practice. We focus primarily on the use of genetic association methods to identify disease-susceptibility variants in well-characterized patient populations. The course will include the principles of genetic study design; pertinent concepts in population genetics, including linkage disequilibrium and population stratification; the principles of genetic association and their application in genome-wide association studies (GWAS) and large-scale sequencing studies; and integrative genomics. Students will also discuss how to use prepared datasets and will have the opportunity to analyze large-scale genetic data. During these sessions, the students will acquire hands-on skills in data quality control and cleaning; linkage disequilibrium mapping; case-control association analysis; principle component analysis; GWAS analysis; sequence alignment and rare variant association testing; and use of bioinformatic tools and public databases.
CI740: Leadership and Teamwork
Course Director: Ajay Singh MBBS, MBA, FRCP(UK) and Johanna Gutlerner, PhD
This course examines different aspects of working with, managing and leading a team. Lectures will discuss the skills and techniques that are needed to manage a talented group of people effectively, pilot successful collaborations within and outside a group, navigate the complexities of the institution, and manage the inevitable conflicts that arise in a high-stakes environment.
Clinical Investigation Courses (Clinical trials & Comparative Research pathways)
CI702A: Clinical Trials Part 1
Course Director: David Wypij, PhD
This course is the first of a four-course series on clinical trials. The purpose of this first course is to provide an introduction to the tools needed to effectively design, conduct, analyze, and interpret clinical trials. The course content will include topics such as: why are clinical trials important; ethical issues in trials; design and implementation components of a trial including recruitment, randomization, blinding, endpoint ascertainment, adverse events, compliance, and follow-up; an introduction to preparing a grant application; and interpreting and communicating trial results. Examples will be provided from the published literature.
Course components will include live sessions, readings, and a final project.
CI702B: Clinical Trials Part 2
Course Directors: Brian Claggett, PhD; Aneesh Singhal, MD
The “nuts and bolts” of clinical trials is best learnt in the doing. In this course, the goal will be to understand the complexity of how trials get started, implemented, and ultimately completed. This 9-week course will cover the “nuts and bolts” of clinical trial design, implementation, and interpretation. Sessions will focus on both conventional and innovative trial designs, on the governance and implementation of clinical trials using examples, statistical aspects (statistical analytic plan, statistical monitoring, sample
size and power), practical aspects such as recruitment and retention and data collection, and interpretation of data. Methods of instruction will include lectures, exercises, and seminars.
Clinical Trials Pathway Courses
CI710: Special Topics in Drug Development and Evaluation
Course Directors: Rosalyn Adam, PhD, Steven Piantadosi, MD, PhD, and Sowmya Chary, MD
Special Topics in Drug Development and Evaluation introduces students to key concepts relevant to development of novel therapeutic agents. Across two parts, this course will cover topics ranging from target discovery and early-stage development, to first-in-human studies and milestones on the road to commercialization. This material will provide insights on the phases of drug development and is complementary to course materials in both the translational investigation track and the clinical trials pathway of the clinical investigation track.
This 2-credit course, offered in the fall semester of the second year of MMSCI, follows a workshop format, taking place over 4 weeks. Students are provided with pre-reading material for each session, and using a flipped classroom model, students are required to actively participate in group discussions in class. Each session will follow a lecture and/or discussion format, where faculty guide discussions based on pre-reading materials and case studies provided.
CI726 (A&B): Advanced Topics in Clinical Trials
Course Directors: Steven Piantadosi, MD, PhD and TBD
This course delves into greater detail on advanced study designs and statistical issues in clinical trials. The course objectives include the following: Describe how designed experiments with human subjects are used in therapeutic development; Summarize principles of clinical trial design including bias control, random error control, randomization, blocking, and masking; Describe quantitative properties of clinical trials including precision of estimation, power, sample size, and accrual dynamics; Compare and contrast specific types of designs of practical and historical interest including translational, dose-finding, safety and efficacy, and comparative trials; Discuss the importance of design and its relation to the analysis of clinical trials; Demonstrate knowledge of clinical trial methods by discussing specific design and/or analysis problems expertly.
Comparative Research Pathway Courses
CI722: Clinical Data Science: Comparative Effectiveness Research I
Course Directors: Geetha Iyer, PhD and Youssef Farag MD, MPH, PhD
This course introduces causal inference methodology for settings in which randomized trials are not available. The course focuses on the use of epidemiologic studies, electronic health records and other sources of observational data for comparative effectiveness and safety research. These methods are described through seamless integration of materials usually taught separately in epidemiology and biostatistics courses. The course introduces methods for confounding and selection bias adjustment along with an emphasis on formulating well-defined questions in clinical research.
The course emphasizes critical thinking and practical applications and the discussion of two case studies. This is the first core course in the Comparative Effectiveness track of the Master of Medical Sciences in Clinical Investigation. It is followed by the 2-part course Clinical Data Science: Comparative Effectiveness Research II.
CI732A: Clinical Data Science: Comparative Effectiveness Research II
Course Directors: Geetha Iyer, PhD and Youssef Farag MD, MPH, PhD
This is a two-part course that applies the core concepts introduced in CI722 to real-world comparative effectiveness research. Part A in the fall lays the groundwork with an introduction to a thorough exploration of risk estimation in clinical research, transitions into the nuances of causal survival analysis,
and dives deep into the details of time-varying treatment. The Part B in the spring moves on to discuss the overarching goals of clinical research analysis, delves into effect measure modification and handling of missing data, and culminates with an introduction to the target trial framework.
In addition to the new topics covered, students will continue to develop their critical thinking and scientific communication skills through the completion of course assessments that will aid in integrating the knowledge acquired throughout the two-part course.
CI732B:
Clinical Data Science: Comparative Effectiveness Research II
Course Directors: Geetha Iyer, PhD and Youssef Farag MD, MPH, PhD
This two-part course applies the core concepts introduced in CI722 to real-world comparative effectiveness research. Part A in the fall lays the groundwork with an introduction to a thorough exploration of risk estimation in clinical research, transitions into the nuances of causal survival analysis, and dives deep into the details of time-varying treatment. The Part B in the spring moves on to discuss the overarching goals of clinical research analysis, delves into effect measure modification and handling of missing data, and culminates with an introduction to the target trial framework.
In addition to the new topics covered, students will continue to develop their critical thinking and scientific communication skills through the completion of course assessments that will aid in integrating the knowledge acquired throughout the two-part course.
Description of Translational Investigation Track Courses
CI760: Investigative Models for Translational Research
Course Directors: Rosalyn Adam, PhD and Martina McGrath, MBBCh
This course provides translational researchers with an introduction to the range of investigative models within the translational research spectrum, with emphasis on the advantages and limitations of each system. Introductory sessions focus on developing well-designed research questions and selecting appropriate analytical methods to interpret results. Case studies will be used to illustrate the different approaches to experimental design. The course will also provide practical information on the range of bench techniques and in silico approaches used in current biomedical research.
CI764A: Systems Biology and Omics Analysis Part I
Course Directors: Rosalyn Adam, PhD and Robert Gentleman, PhD
The goals of this course are to introduce participants to fundamental concepts in Genomics and systems biology and to provide a basis for experiments that generate large genomic, transcriptomic, proteome and combined datasets. An introduction to the structure of the human genome and obtaining information about gene expression and gene regulation is followed by exploration of experimental design for generation of large datasets and their integration using systems biology principles. DNA sequencing, RNA sequencing and Mass spectrometry-based proteomics and related technologies are discussed, and the course concludes with a discussion of genome-wide screens and therapeutic approaches.
CI764B: Systems Biology and Omics Analysis Part II
Course Director: Ashwini Jambhekar, PhD
The goals of this course are to build upon concepts introduced in Part I and focus on application of methods to identify genes that are involved in human disease and how to develop diagnostics, drugs and therapies. The course features in-depth discussion of the translation of genetic/genomic information into novel diagnostics and therapies, including DNA based, RNA based and protein-based analyses. The instruction will employ real-world examples of the development of therapeutics using precision medicine approaches. These cases will illustrate specific teaching points relevant to the application of genetic and genomic investigation to precision medicine.
CI762: Cell and Molecular Biology in Medicine
Course Directors: Jing Zhou, PhD
This course will provide translational investigators with a broad understanding of the fundamental processes that drive cell function in health and disease. An overview of cell biology will be followed by an introduction to specific cell functions that play key roles in disease processes, including viral entry, cellular uptake of lipoproteins, cilia function, inflammation, protein degradation, autophagy, and fibrosis. The course will focus on cutting-edge techniques for cell biological investigation. Specific disease entities, including ciliopathy, cancer, cardiovascular, and neurodegenerative diseases, are explored as examples of studies in cellular and molecular medicine.
The course will be complemented with describing methods used to investigate biological processes. Learners will gain experience interpreting data from cellular and molecular biology studies and apply it to answer research questions. Furthermore, students will develop skills to design a research approach to study a clinical question using cell and molecular biology techniques.
The course will comprise lectures, case-based learning sessions, journal clubs, and other interactive activities to guide students through basic cell biological processes and behaviors and then apply that knowledge to the pathophysiology of common diseases. Key concepts will be emphasized with examples from the literature.
CI766: Translating Innovation into Practice
Course Director: Sowmya Chary, MD
This course is designed to provide learners with an introduction to the process of translating research innovations into clinical practice. It will examine the design of first in human studies (including integration of translational medicine approaches, biomarker discovery and validation), the regulatory process to bring an innovation to the clinic, and academic/industry partnerships. Securing funding through industry networks, and how to approach commercializing a discovery will be discussed, illustrated through case examples from guest lecturers.
CI716: R Workshop Training Course
Course Director: Jesse Raffa, PhD
This 1 credit course, comprising nine 90-minute sessions, during the J term of Year 1 of MMSCI program will introduce participants to using R and RStudio. R is a simple programming environment that enables the effective handling of data, while providing excellent graphical support. RStudio is a tool that provides a user-friendly environment for working with R.
This practical, hands-on course is intended to provide basic R programming knowledge. Participants will learn the basics of R for reproducible data wrangling and visualizations (ggplot2), how to perform data analyses requiring a basic knowledge of R and use R to produce data tables and graphics. This course will act as an introduction to R and will provide foundational teaching upon which subsequent courses, CI764 Systems Biology and Omics Analysis, will build.
BCMP301QC: Translational Pharmacology (Optional course for all students)
Course Directors: David Golan, MD, Catherine Dubreuil, PhD, Mark Namchuk, PhD, Nuru Stracey, PhD
This intensive course, held during three weeks in January (13 class days), covers principles of pharmacology and their translation into new drug discovery and development. Students participate in project groups, composed primarily of graduate students, to propose a drug development strategy from target choice through clinical trials. Most sessions include lectures, panel discussions, and/or case studies presented by Harvard faculty and faculty experts from the pharmaceutical and biotechnology industries; several sessions provide scheduled time to work on the group project with expert facilitators
from industry. Evaluation is based on written and oral presentations of the group project and on class participation. Enrollment may be limited.
VII. Expectations for students by term or year
Students are expected to participate fully in the required components of the program, including the intensive workshops and any pre-workshop mini-courses, the flipped classroom series, the longitudinal seminar, and the mentored research project. Students will be formally evaluated in each course, through participation, online quizzes and homework assignments, team projects, and written work. Attendance is required for all course meetings.
While the MMSCI will be a complete, self-standing program of study that meets all of the credit requirements for matriculation of students, MMSCI enrolled students will be able to enroll in courses at other Harvard Schools, with the permission of those schools, and with the guidance and permission of the program director, their research mentor, and relevant course directors. With respect to elective crossregistered courses, students are notified that they are expected to abide by the policies that apply to the course/school in which the elective is taken (including attendance and integrity in science) and are informed that they must receive a satisfactory grade in any for-credit elective in order to graduate, since any unsatisfactory grade on a student’s transcript precludes the student from receipt of a diploma.
Students are expected to abide by the policies, including attendance (See Section 2.02) and academic integrity (See Section 4.09), of each school in which courses are taken.
VIII. Policies
Students must abide by all policies described in the Master’s Student Handbook in addition to the MMSCI-specific policies described in this Plan of Instruction
Absences/Attendance
Students are required to attend every MMSCI course in person unless otherwise stated. Attendance is taken via a physical sign-in sheet that is collected after 30 min have passed. Students must sign-in within 30 minutes of the start of class or they will be considered absent (unexcused). Students will be flagged for discussion at a MMSCI leadership meeting after missing 10% of a class (excused or unexcused).
Absences from class must be requested in advance if possible, via the Absence Request Form on the MMSCI Student Hub. Unreported/unexcused absences may result in disciplinary action. The protocol is:
1. Submit your absence request at least one month in advance of your travel date (personal travel & academic conferences) or at least one week in advance for any other reason
a. Our strong recommendation is to not book travel until you've received notice from the program about whether or not your request has been approved.
2. Your program manager will email you a decision, and if approved, will also email your course director(s) and TF(s) to inform them of your excused absence
a. Complete the remediation assigned by your course director(s)/TF(s)
Excused absences will not be granted for requests where you would miss an exam