The proliferation of statistical research in the area of clinical trials coupled with the critical role of clinical research in the drug approval process and health care in general necessitate a succinct document on statistical issues related to clinical trials. Clinical and research data are often gathered within a limited time frame while the processes to which clinical attention is being given, and those which are being studied continue beyond that time frame's boundaries. Describe the role that biostatistics serves in biomedical and public health research. As the field of statistics, the “ theoretical science or formal study of the inferential process, especially the planning and analysis of experiments, surveys, and observational studies.” (Piantadosi 2005). The use of statistics in clinical trials allows the clinical researcher to form reasonable and accurate inferences from collected information, and sound decisions in the presence of uncertainty. Statistics are key in preventing errors and biases in medical research. Statistical Concepts for Clinical Research PJ Heagerty Department of Biostatistics University of Washington 1 ITHS 2012. CTSA Core Competencies: Statistics 1. Describe the basic principles and practical importance of random variation, systematic error, sampling error, measurement error, hypothesis … 2.

Statistical methods provide formal accounting for sources of variability in patients’ responses to treatment. The role of statistics in clinical trial design and analysis is acknowledged as essential in that ICH guideline.