Introduction to Clinical and Translational Research: Statistical Model and Systematic Reviews - Session 5

The first section of this session discusses the process of developing a conceptual and statistical model that can most effectively test a hypothesis. The second section describes the role of systematic reviews of research literature and the statistical meta-analyses designed to collectively assess their findings.

About this Resource

Statistical models are mathematical equations that represent relationships between variables in a study, and matching appropriate statistical models with studies is a crucial element of conclusive research. In the first section of this session, "Clinical Translational Research: The Statistical Model," a lecturer demonstrates the process of defining research models that represent and test hypotheses effectively. The lecturer discusses the selection of appropriate statistical models for various types of investigations, and how to construct a conceptual model that tests the relationship between variables that affect health outcomes. 

Systematic reviews of large numbers of published research studies, with statistical analyses of their collective findings conducted through meta-analyses, are used to help develop clinical guidelines and indicate needed directions for additional research. In "Bringing Evidence Together: Systematic Reviews and Meta-Analysis," a lecturer discusses their roles in clinical and translational research. Participants will learn how to evaluate the quality and applicability of systematic reviews meta-analyses, and how research studies progress from evidence to clinical guidelines.

Course Syllabus/Topics

Clinical Translational Research: The Statistical Model

  • The Modeling Process to Answer Research Questions
  • Defining Study Populations and Study Design
  • Construction of a Conceptual Model
  • Selection of Statistical Model

Bringing Evidence Together: Systematic Reviews and Meta-analysis

  • Defining Systematic Reviews and Meta-analysis
  • Role of Systematic Reviews and Meta-analysis in CTR
  • Evaluating Systematic Reviews and Statistical Meta-analyses
  • Assessing Quantitative Meta-analyses and Study Heterogeneity
  • Publication Bias in Systematic Reviews and Meta-analyses

Recommended background

Please complete the following prior to attending the short course, "Clinical Translational Research: The Statistical Model, and "Bringing Evidence Together: Systematic Reviews and Meta-analysis."

  • Pre-test on Clinical Translational Research
  • View the two-part video resource
  • Participant Break-out Session Guide
  • Read the articles as mentioned in Session 1

Suggested Readings

  1. Liu R1, Wang X, Chen GY, Dalerba P, Gurney A, Hoey T, Sherlock G, Lewicki J, Shedden K, Clarke MF. The prognostic role of a gene signature from tumorigenic breast-cancer cells. N Engl J Med. 2007 Jan 18;356(3):217-26.
  2. Slamon DJ1, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, Fleming T, Eiermann W, Wolter J, Pegram M, Baselga J, Norton L. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001 Mar 15;344(11):783-92.
  3. Pritchard KI, Shepherd LE, O'Malley FP, Andrulis IL, Tu D, Bramwell VH, Levine MN; National Cancer Institute of Canada Clinical Trials Group. HER2 and responsiveness of breast cancer to adjuvant chemotherapy. N Engl J Med. 2006 May 18;354(20):2103-11.
  4. Stark A1, Kucera G, Lu M, Claud S, Griggs J. Influence of health insurance status on inclusion of HER-2/neu testing in the diagnostic workup of breast cancer patients. Int J Qual Health Care. 2004 Dec;16(6):517-21.
  5. Drummond MB, Dasenbrook EC, Pitz MW, Murphy DJ, Fan E. Inhaled corticosteroids in patients with stable chronic obstructive pulmonary disease: a systematic review and meta-analysis. JAMA. 2008 Nov 26;300(20):2407-16.
  6. Carrier M1, Le Gal G, Wells PS, Rodger MA. Systematic review: case-fatality rates of recurrent venous thromboembolism and major bleeding events among patients treated for venous thromboembolism. Ann Intern Med. 2010 May 4;152(9):578-89.
  7. Antman EM, Lau J, Kupelnick B, Mosteller F, Chalmers TC. A Comparison of Results of Meta-analyses of Randomized Control Trials and Recommendations of Clinical Experts: Treatment of Myocardial Infarction. JAMA. 1992 July 8;268 (2)240-248.


Yes. Participants who complete the course receive a Certificate. Participants must watch the videos and attend the in-person session.

No. In addition to K Scholars, this course is open to faculty, clinicians, community health workers, fellows, post-docs, TL1 and F trainees, as well as medical, OT/PT, pharmacy and other students who intend to conduct clinical and translational research.


Jonathan Samet, MD, MS
Former Director, SC CTSI Workforce Development; Currently, Dean and Professor Colorado School of Public Health, University of Colorado, Denver

NIH Funding Acknowledgment: Important - All publications resulting from the utilization of SC CTSI resources are required to credit the SC CTSI grant by including the NIH funding acknowledgment and must comply with the NIH Public Access Policy.