Monday, 5 October 2015

Designing Clinical Trials Researchers design clinical trials

Researchers design clinical trials to answer specific research questions related to a medical product. These trials follow a specific study plan, called a protocol, that is developed by the researcher or manufacturer. Before a clinical trial begins, researchers review prior information about the drug to develop research questions and objectives.

Then, they decide:-

-Who qualifies to participate (selection criteria)
-How many people will be part of the study
-How long the study will last
-Whether there will be a control group and other ways to limit research bias
-How the drug will be given to patients and at what dosage
-What assessments will be conducted, when, and what data will be collected
-How the data will be reviewed and analyzed Clinical trials follow a typical series from early, small-scale, Phase 1 studies to late-stage, large scale, Phase 3 studies.

S. Pandarinath, Pharmacist, Certified Pharmacovigilance Professional.

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