Sample size Calculation in Clinical Research

#Sample_Size_Clinical_Trials The sample size of the study is directly linked with the primary objective, endpoint, study design and the analysis method for the primary objective.

In clinical research, during the planning stage of a clinical study, the following questions are of particular interest to the investigators: (i) how many subjects are needed in order to have the desired power for detecting a clinically meaningful difference (e.g., an 80% chance of correctly detecting a clinically meaningful difference), and (ii) what's the trade-off between cost-effectiveness and power if only a small number of subjects are available for the study due to limited budget and/or some medical considerations.

"In clinical research, sample size calculation plays an important role in assuring validity, accuracy, reliability, and integrity of the intended clinical study" - Nirali Mehta

#Book: Sample size calculation in clinical research
#Author: Shein -Chung - Chow; Jun Shao; Hansheng Wang
#Publication: Marcel Dekker, Inc.

#Biostatistician #samplesize #clinicalresearch #studydesign #protocol #pharmaceuticals #PharmaStats_Statistical_Consultancy_Services 04.09.2020