Clinical Research

Biostatistics in Clinical Trials:

Biostatistics an application of statistics is nothing but the science of the analyzing design and data of biological experiments, especially in medicine and related research. By definition, it is the collection, summarization, and analysis of data from those experiments; and the interpretation of, and inference from, the results.

Statistical analyses may be helpful in answering scientific questions brought to light while planning and executing a research. While planning for scientific question one should be ethical and valid. It should dictate both the design of the study and the analysis of the collected data.

To validate the research it should have a scientifically validated statistical plan. The role of biostatistician hence starts from commencement of research hypothesis and runs parallel to study progress. Sir R.A. Fisher says, β€œTo call in the statistician after the experiment is done may be no more than asking him to perform a post mortem examination: he may be able to say what the experiment died of.”

The role of statistician is considered to be most complex and arduous task. Currently there are multiple regulatory agencies are planning to guidance documents and are in process to develop guidelines which will help statisticians to formulate a better statistical plan. Such steps will finally benefit the research world to develop more comprehensive R & D sector.

Statistics can never PROVE or DISPROVE a hypothesis, it only suggests to accept or reject the hypothesis based on the available evidences. Statistics can be a very useful tool to make decisions, but it should not be used only as a yardstick.

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