Research: Writing effective statistical methodology for a research proposal

"Clinical research is judged to be valid not by the results but how it is designed and conducted. The cliché of ‘do it right or do it over’ is particularly apt in clinical research."  This publication is a great resource to help you organise and plan your research team.

The Journal of Investigative Medicine published an informative article titled "Bridging Clinical Investigators and Statisticians: Writing the Statistical Methodology for a Research Proposal."

The introduction:  "Clinical research is judged to be valid not by the results but how it is designed and conducted. The cliché of ‘do it right or do it over’ is particularly apt in clinical research.

One of the questions a clinical investigator frequently asks in planning clinical research is “Do I need a statistician as part of my clinical research team?” The answer is “Yes!” since a statistician can help to optimize design, analysis and interpretation of results, and drawing conclusions. When developing a clinical research proposal, how early in the process should the clinical investigator contact the statistician? Answer - it is never too early. Statistics cannot rescue a poorly designed protocol after the study has begun. A statistician can be a valuable member of a clinical research team and often serves as a co-investigator. Large multicenter projects such as Phase III randomized clinical trials for drug approval by a regulatory agency nearly always have a statistician (or several) on their team. However, smaller, typically single center studies may also require rigorous statistical methodology in design and analysis. These studies are often devised by young clinical investigators launching their clinical research career who may have not collaborated with a statistician. Many clinical investigators are familiar with the statistical role in the analysis of research data1, but researchers may not be as aware of the role of a statistician in designing clinical research and developing the study protocol. In this paper we discuss topics and situations that clinical investigators and statisticians commonly encounter while planning a research study and writing the statistical methods section. We stress the importance of having the statistical methodology planned well in advance of conducting the clinical research study. Working in conjunction with a statistician can also be a key training opportunity for the clinical investigator beginning a clinical research career."