Program Content

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Program Content

The program is comprised of nine (9) foundation courses, a concentration in either advanced epidemiology or in clinical trials, and choice of elective (Drug Development, Secondary Analysis of Clinical Trials, or Survey Design).

Foundation Courses

  • Biostatistics – This course addresses how to organize, summarize, and display quantitative data; and the applied use of statistical software (Stata)
  • Epidemiology – This course covers the basic principles and methods of epidemiology, including disease (outcome) measures, measures of association, study design options, bias, confounding, and effect modification.
  • Biostatistical Computing – This course focuses on the basics of Stata, including learning key commands, creating do-files, organizing data for analysis, and checking for errors. More advanced lectures will focus on using Stata for regression, survival analysis, and generating polished figures and tables.
  • Ethics and Regulation – This course reviews some common challenges in the conduct and review of biomedical human subjects research, including the evolution of ethical codes and regulations, the responsibility of physicians as investigators, the preparation of research protocol applications and informed consent documents, and the challenges of conducting research involving children and adolescents.
  • Leadership in Medicine – This course examines different aspects of working and leading a team. Lectures discuss the need to manage a 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.
  • Applied Regression – This course provides an understanding of the basic principles and uses of linear and logistic regression models for clinical research.
  • Survival Analysis – This course provides instruction to describe time-to-event data and compare groups with a time-to-event outcome, interpret the coefficients and control for confounding using a Cox proportional hazards model, interpret interaction terms and incorporate time varying covariates in a Cox model as well as assess the proportional hazards assumption.
  • Correlated Outcomes – This course covers methods to analyze longitudinal data, including the use of linear regression models. Topics will include polynomial trends for time (e.g., linear or quadratic) and linear mixed-effects models. Students will be able to understand the types of missing data that occur in longitudinal and cross-sectional analysis as well as understand the assumptions associated with each analysis approach.
  • Causal Design – Causal inference is an overarching objective of most forms of medical and epidemiological investigation. Students will have a deeper understanding of observational approaches, especially from the perspective of overcoming the problem of confounding. Students will be able to develop approaches toward identifying confounders, especially using DAGs to identify them. Other topics will include the rules of D-separation and conditioning on common effects.

Electives

  • Drug Development – wholly webinar based, this elective consists of weekly webinars generally held at 9 am Eastern Time. There are no individual homework assignments and students have the opportunity to interact with the faculty in real time.
  • Secondary Analysis of Clinical Trials – the pre-recorded lectures in this elective are supported by interactive webinars and have an associated individual assignment (quiz).
  • Survey Design – this elective consists of a blend of recorded online lectures and interactive webinars. The recorded lectures have an associated individual assignment (quiz).

Each elective has an affiliated team assignment. Students will be divided into temporary teams within electives and asked to make a presentation.

Concentrations

  • Advanced Quantitative Methods of Epidemiology – the Epidemiology concentration provides instruction in the epidemiological and biostatistical methods used in observational clinical research. Training in the oral and written presentation of clinical research is also provided.
  • Principles and Practice of Clinical Trials – the Clinical Trials concentration delivers instruction in the conduct, implementation, and analysis of clinical trials, with a focus on the methods of study design, ethics, recruitment, and biostatistical considerations that are used in designing and analyzing clinical trials.

Objectives

After completing this program, scholars will be able to:

  1. Perform both observational and experimental clinical research using the methods introduced in this program.
  2. Plan and implement one or more clinical research projects.
  3. Analyze, interpret, and present clinical research data.

Our

Mission

Our Mission

To create and nurture a diverse community of the best people committed to leadership in alleviating human suffering caused by disease