The role of biostatisticians goes far beyond analyzing data at the end of a clinical study. Instead, they should be involved in clinical trial management right from the start to maximize the chances for a new drug’s market approval.
Biostatisticians in clinical trial management have a long to-do list. They advise on study design, calculate the right sample size, and ensure that the enrolled patients are correctly randomized. They help define endpoints, provide definitions for data analysis and create tables and figures for the clinical study report.
Malin Schollin, Director of Biostatistics at LINK Medical
“People often think that biostatistics comes in at the end of a clinical trial, but this can lead to a lot of issues, for example, when you find out too late about missing data or incorrect randomization.”
“There is great value in having a statistician on board during the entire project because then we can take part in the decision making, and help assess how it will affect analyses,
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