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Protocol Design Issues

Many study designs have been presented and approved over the years. The best all had something in common: they each were well written and had internal integrity.

  • The goal of the study should be clear.
  • The goal should clearly fit into a larger picture.
  • The objectives should contribute to the goal.
  • The end points should contribute to the objectives.
  • The design should allow all of the objectives to be met scientifically.
  • The statistical complexity should be appropriate.

Studies are designed to answer a particular question. Some designs are adopted to gain minimum information from many subjects or, alternatively, maximum information from the fewest subjects. No studies are designed with ethics and subject protection as the primary goal.

We want subjects to be respected and protected.  We want the study to be capable of yielding evaluable results.

Grant applications make terrible protocols. Grants extol such virtues as the skill and background of the investigator, the importance of work in this area, a complete literature search, and why funding the study is imperative.  A research protocol tells how this can all be accomplished.


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