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 ensure optimum interaction and communication among the investigators and statisticians of the research team. Methods. The protocol described in this document is designed to systematically guide a researcher through a sequence of planning steps and checkpoints to ensure proper experimental design, data management, statistical analyses, and interpretation. Results. The investigator and the statistician, as a collaborative team, will be able to determine the most effective and appropriate procedures and tools necessary for the successful completion of a research project. Significance. Planning an experimental study necessitates 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 more of the following: failure of the established testable hypothesis, uncontrolled biases, insufficient sample size, lack of appropriate controls, variability in specimen preparation, improper calibration of instruments or standardization of measurements, incorrect data entries, inappropriate statistical analyses, errors in interpretation of statistical analyses, and erroneously drawn conclusions. Standard guidelines will eliminate many of these potential problems.