Question
Explain the steps taken for minimising bias in a research setup of a clinical trial.
Answer :
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Bias in a clinical trial refers to systematic errors that can distort the estimation of treatment effects and threaten the validity and reliability of study findings. Minimising bias is therefore a critical objective in the design, conduct, analysis, and reporting of clinical research. Several methodological steps are taken at different stages of a clinical trial to reduce various forms of bias such as selection bias, performance bias, detection bias, and attrition bias. The first step in minimising bias begins at the planning stage through a well-defined research protocol. Clear formulation of research objectives, eligibility criteria, outcome measures, and statistical analysis plans helps prevent selective reporting and analytical bias. Pre-registration of the trial in a clinical trial registry further enhances transparency and reduces the risk of outcome reporting bias by ensuring that deviations from the original plan are documented and justified. Randomisation is one of the most effective methods to minimise selection bias. By allocating participants to intervention and control groups using random procedures, such as computer-generated random numbers or random number tables, the influence of known and unknown confounding variables
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