Education Core | Study Design in Clinical & Translational Research

A firm grasp of study design is essential for those who aim to conduct clinical investigations, and equally essential for those who evaluate others’ work or read the medical literature as a guide to clinical practice or policy.  This series of 8 lectures will provide the conceptual tools and vocabulary needed to write a grant proposal, prepare a protocol, review clinical and translational studies, or appraise the strength of evidence in published research. The most prevalent observational and experimental designs will be highlighted and compared as to merits, shortcomings, and keys to success. Additional presentations will show how to assess the quality of measurements and how to estimate the sample size needed for adequate precision and statistical power. Numerous examples will be drawn from current journals and the lecturer’s experience in laboratory, clinical, and epidemiological studies.

Target Audience

Medical and post-doctoral faculty, fellows, and clinical research staff at Boston Children's Hospital who desire further knowledge of topics in study design. 


Upon completion of this activity, participants will be able to:

  • Identify and distinguish the key factors in study design.
  • Judge the most appropriate design for different stages of biomedical investigation.
  • Interpret and evaluate the statistical design and analysis aspects of a research proposal or published report.
  • Develop a research protocol with high-quality statistical content; in particular:
    • Formulate and justify the experimental or observational design.
    • Choose measures of exposure and outcome with optimal properties.
    • Prepare a thorough and pertinent statistical analysis plan.
    • Calculate precision, power, and detectable effects.
  • Identify and negotiate the trade-offs among design parameters within constraints of time and resources.