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 data, 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.
Sample Clinical Research Proposal by qzk17655
As of September 2009, 46 medical research institutions in the United States have been granted a Clinical and Translational Science Award (CTSA, >). When the CTSA program is fully implemented, it will support approximately 60 centers across the nation. Some CTSA awardees offer biostatistical collaboration or institutional pilot grants for early career clinical investigators in need of statistical expertise. Many of these research centers offer Biostatistics courses or seminar series that are specifically designed for clinical researchers. This paper evolved from a CTSA course, “Clinical Research from Proposal to Implementation”, taught at the University of Texas Southwestern at Dallas. Take advantage of any such course offerings and resources.