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
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
I. Introduction and First Exercises. NutrClinPract. April 1998;13(2):70-73.
II. Why Randomize? NutrClinPract. June
III. Error Types. NutrClinPract. August
IV. Subgroup Analyses. NutrClinPract. October
V. End Points. NutrClinPract. December
VI. Treated Control Groups. NutrClinPract. February
VII. Interpreting Tests. NutrClinPract. April
VIII. Review Articles. NutrClinPract. June
IX. More About Meta-Analysis. NutrClinPract. 1999;14(5):264-267.
X. What Have We Read? NutrClinPract. December
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
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.