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A Guide for Writing a Protocol for a clinical trial

Awad Mohamed Ahmed, Md
Professor of Medicine, University of Bahr Elghazal, Khartoum, Sudan
Randomized controlled trial or randomized clinical trial (RCT) is an epidemiological experiment to study a new preventive or therapeutic regimen. It is most commonly used in assessing the effectiveness of health care services or health technologies such as pharmaceutical products (e.g. drugs or vaccines),medical devices or new surgical procedures. A simple description of a trial design is: patients’ recruitment and allocation into study and control groups, intervention, follow up and analysis and drawing of conclusions.
A protocol for a clinical trial is a study plan, designed to describe objectives, background, methodology,organization, the participants, interventional procedures and assessments tools of the trial. In this paper we will describe the different steps of preparing a sound and efficient trial protocol.


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