GUIDELINES FOR EXPERIMENTAL STUDIES

Objectives. The purpose of this document is to present guidelines for the training of researchers and for the planning of experiments that e nsure optimum interaction and communication among the investigators an d statisticians of the research team. Methods. The protocol described in this document is designed to systematically guide a researcher thro ugh a sequence of planning steps and checkpoints to ensure proper expe rimental design, data management, statistical analyses, and interpreta tion. Results. The investigator and the statistician, as a collaborati ve team, will be able to determine the most effective and appropriate procedures and tools necessary for the successful completion of a rese arch project. Significance. Planning an experimental study necessitate s much thought. Lack of essential communication with a statistician in the initial stages of the experimental design can doom the experiment to failure. Flawed research studies may be associated with one or mor e of the following: failure of the established testable hypothesis, un controlled biases, insufficient sample size, lack of appropriate contr ols, variability in specimen preparation, improper calibration of inst ruments or standardization of measurements, incorrect data entries, in appropriate statistical analyses, errors in interpretation of statisti cal analyses, and erroneously drawn conclusions. Standard guidelines w ill eliminate many of these potential problems.