Clinical Research Methods

Director: Todd Ogden, PhD

The Mailman School offers the degree of  Master of Science in Biostatistics, with an emphasis on issues in the statistical analysis and design of clinical studies. The Clinical Research Methods track was conceived and designed for clinicians who are pursuing research careers in academic medicine. Candidacy in the CRM program is open to anyone who holds a medical/doctoral degree and/or has several years of clinical research experience.

Competencies

In addition to achieving the MS in Biostatistics core competencies, graduates of the 30 credit MS Clinical Research Methods Track develop specific competencies in data analysis and computing, public health and collaborative research, and data management. MS/CRM graduates will be able to:

Data Analysis and Computing

  • Apply the basic tenets of research design and analysis for the purpose of critically reviewing research and programs in disciplines outside of biostatistics;

  • Differentiate between quantitative problems that can be addressed with standard methods and those requiring input from a professional biostatistician.

Public Health and Collaborative Research

  • Formulate and prepare a written statistical plan for analysis of public health research data that clearly reflects the research hypotheses of the proposal in a manner that resonates with both co-investigators and peer reviewers;

  • Prepare written summaries of quantitative analyses for journal publication, presentations at scientific meetings, grant applications, and review by regulatory agencies;

Data Management

  • Identify the uses to which data management can be put in practical statistical analysis, including the establishment of standards for documentation, archiving, auditing, and confidentiality; guidelines for accessibility; security; structural issues; and data cleaning;

  • Differentiate between analytical and data management functions through knowledge of the role and functions of databases, different types of data storage, and the advantages and limitations of rigorous database systems in conjunction with statistical tools;

  • Describe the different types of database management systems, the ways these systems can provide data for analysis and interact with statistical software, and methods for evaluating technologies pertinent to both; and

  • Assess database tools and the database functions of statistical software, with a view to explaining the impact of data management processes and procedures on their own research. 

Required Courses

The required courses enable degree candidates to gain proficiency in study design, application of commonly-used statistical procedures, use of statistical software packages, and successful interpretation and communication of analysis results. A required course may be waived for students with demonstrated expertise in that field of study. If a student places out of one or more required courses, that student must substitute other courses, perhaps a more advanced course in the same area or another elective course in biostatistics or another discipline, with the approval of the student’s faculty advisor.

The program, which consists of 30 credits of coursework and research, may be completed in one year, provided the candidate begins study during the summer semester of his or her first year. If preferred, candidates may pursue the MS/CRM on a part-time basis. The degree program must be completed within five years of the start date.

The curriculum, described below, is comprised of 24 credits of required courses, including a 3-credit research project (the “Master’s essay”) to be completed during the final year of study, and two electives of 6 credits. Note that even if a course is waived, students must still complete a minimum of 30 credits to be awarded the MS degree.

Course #

Course

Points

P6104

Introduction to Biostatistical Methods

3

P6400

Principles of Epidemiology

3

P8100

Applied Regression I

3

P8110

Applied Regression II

3

P8120

Analysis of Categorical Data

3

P8140

Introduction to Randomized Clinical Trials

3

P8438

Epidemiology II: Design & Conduct of Observational Epidemiology

3

P9160

Master's Essay in Biostatistics: Clinical Research Methods 

3

 

Electives

Commonly chosen elective courses include:

Course #

Course 

Points

P6110

Statisitical Computing Using SAS

3

P8112

Systematic Review & Meta-Analysis

1.5

P8142

Clinical Methodology

3

P8157

Latent Variable and Structural Equation Modeling for Health Sciences

3

P8180

Research Data Coordination: Principles and Practices

3

P8405

Genetics in Epidemiology

3

P8417

Selected Problems of Measurement in Epidemiology

3

P8482

Outcomes Research: Methods & Public Health Implications

3

P8541

Cost Benefit Analysis and Health

3

P8545

Analysis of Large Scale Data

1.5

89260

Building Interdisciplinary Research Models

2

 

Master's Essay

As part of MS/CRM training, each student is required to register for the 3-credit Master's essay course (P9160). This course provides direct support and supervision for the completion of the required research project, or Master's essay, consisting of a research paper of publishable quality. CRM candidates should register for the Master's essay during the spring semester of their final year of study. Students are required to come to the Master's essay course with research data in hand for analysis and interpretation.

CRM graduates have written excellent Master's essays over the years, many of which were ultimately published in the scientific literature. Some titles include:

  • A Comprehensive Analysis of the Natural History and the Effect of Treatment on Patients with Malignant Pleural Mesothelioma

  • Prevalence and Modification of Cardiovascular Risk Factors in Early Chronic Kidney Disease: Data from the Third National Health and Nutrition Examination Survey

  • Perspectives on Pediatric Outcomes: A Comparison of Parents' and Children's Ratings of Health-Related Quality of Life

  • Clinical and Demographic Profiles of Cancer Discharges throughout New York State Compared to Corresponding Incidence Rates, 1990-1994

Sample Timeline

Candidates may choose to complete the CRM program track on a part-time basis, or complete all requirements within one year (July through May). To complete the degree in one year, coursework must commence during the summer term. 

Note that course schedules change from year to year, so that class days/times in future years will differ from the sample schedule below; you must check the current course schedule for each year on the course directory page.

Summer IFall ISpring ISummer IIFall IISpring II
P6104-Introduction to Biostatistical MethodsP8100-Applied Regression IP8110-Applied Regression IIElectiveP8140-Introduction to Randomized Clinical TrialsP8438-Epidemiology II
 P6400-Principles of EpidemiologyP8120-Analysis of Categorical Data ElectiveP9160-Master's Essay in Biostatistics: Clinical Research Methods

 

Contact

Justine Herrera, MA
Director of Academic Programs
Department of Biostatistics
Columbia University
jh2477 [at] columbia.edu
(212) 342-3417

More information on Admission Requirements and Deadlines.