Study Design

The principles of high quality research study design apply equally to both the clinical researcher and the bench scientist. While it is tempting to "dive in" to a research project, most seasoned investigators would agree that the extra time spent designing a study pays off in higher quality findings and greater scientific rigor. A.S.P.E.N. provides a wealth of information on designing research in nutrition support. There is also a large body of publicly available resources to promote rigorous study design. A selection of these materials is provided below.

•  Koretz RL. Considerations of Study Design. NutrClinPract. 2007; 22:593-598.  

•  Twomey PL. Invited Review: Getting Started in Clinical Nutrition ResearchNutrClinPract.1991;6(5):175-183.  

Dr. Ronald Koretz wrote a series of ten articles under a feature called “The Reading Corner” in Nutrition in Clinical Practice.  These were 3-4 page research tutorials that posed situations, asked questions, and discussed methodology to resolve research challenges.   While the science of clinical nutrition and metabolism has advanced significantly in the years since these tutorials were published, the “thinking processes” and approach to problem solving are still relevant today. 

I. Introduction and First ExercisesNutrClinPract. April 1998;13(2):70-73.  

II. Why Randomize? NutrClinPract. June 1998;13(3):136-140.  

III. Error TypesNutrClinPract. August 1998;13(4):182-185.  

IV. Subgroup AnalysesNutrClinPract. October 1998;13(5):230-234. 

V. End PointsNutrClinPract. December 1998;13(6):291-294.  

VI. Treated Control GroupsNutrClinPract. February 1999;14(1):33-35.  

VII. Interpreting TestsNutrClinPract. April 1999;14(2):69-72.   

VIII. Review ArticlesNutrClinPract. June 1999;14(3):138-141.  

IX. More About Meta-AnalysisNutrClinPract. 1999;14(5):264-267.  

X. What Have We ReadNutrClinPract. December 1999;14(6):315-317.  

 

In addition to the material listed above, many online training resources are available free or at low cost. Further, many researchers share slide decks and audio lectures online, and these are often an excellent source of information for researchers who are effective self-learners. However, as with any online resource, it is important to be prudent in selecting your sources of learning materials–and choosing reputable sources.

Several slides sets are available from the NIH Clinical Center website and other reputable websites on topics such as: basics of epidemiology, overview of clinical trials, how to set up and begin clinical research, and study design and analysis in epidemiology. In addition, a wealth of information, templates, and resources are available on how to conduct clinical research. The following online resources are available through Global Health Trials: downloadable templates for consent documents, budget tracking tools, and resources on Good Clinical Practice. A very large slide deck on epidemiology, study design, and basic statistics for clinical research is also available.