Statisticians play an integral part in this clinical study process. They assist the clinical research scientists, usually physicians, to design the clinical trials, including selection and validation of study measurements, and definition of subsequent statistical analyses. This design work must be carefully done in order to yield valid scientific conclusions in support of particular properties of the drug's safety and efficacy. They co-author the reports of the trials' results which are assembled into volumes which are submitted to drug regulatory agencies worldwide for approval to sell the drug. The drug's labeling for prescribing physicians and patients contains information about the drug's proper use.
Statisticians contribute to the design and content of the product's labeling.
The labeling information is reviewed by statisticians for correctness. The attached schematic summarizes the drug development time line. After drug approval, the statistician's job is not over. Statisticians work with economists to document the drug's impact on costs in comparison to the costs of necessary treatment of the disease for various alternatives which do not involve the drug. Market research involves statisticians who help assess the drug's potential financial impact on the company.