Are the statistical analysis procedures clearly defined?
Your statistical analysis plan should be clearly defined in the protocol, as well as what considerations will be taken for any anticipated problems with that analysis. For example, will any considerations be taken into account for more than the anticipated number of participants being withdrawn from the study? Will this be taken into account for only those who meet a certain criteria? Remember, your subject number may have been determined by a statistical power calculation in order to determine the greatest amount of statistical significance using the minimum number of subjects to accomplish this. Should a greater number of subjects be withdrawn from the study than was accounted for in this calculation, your significance may decline. The calculation of your subject number should be based on your primary outcome measurement. Q: What are the most important elements to consider when placing your trial and whom can you depend on? A: There are many options in placing a clinical study. If yo
