Evaluation Of A Clinical Trial Essay

1602 WordsSep 27, 20167 Pages
1.3 Clinical Trials A clinical trial is a prospective study comparing the effect and value of an intervention(s) against a control in human beings (Friedman & De Mets, 2010). It is an assured way of determining whether an intervention has the hypothesized effect since researchers have control of most of the cofounders involved in the studies. Each of the participants is followed onward in time from a defined point in time, which is the baseline for the study. Participants are randomly assigned to the various intervention options to create comparable intervention groups. A protocol is one of the requirements of a properly designed trial. A protocol, which is an agreement between the investigator, the participant and the scientific community, provides the background, objectives, design and organization of the trial. This is a document that is prepared way before participants are enrolled, and remains essentially unchanged unless for minor updates. Any major changes altering the direction of the trial need to be carefully justified; a rationale behind the changes should be clearly described. In clinical trials, an outcome is defined as a variable intended for comparison between groups in order to assess the efficacy or harm of an intervention (Chan, 2004). An outcome may be primary or secondary. A primary outcome, measured at the primary endpoint, is the variable that forms the basis of the study and is predetermined by the investigator at the design stage of the study. A

More about Evaluation Of A Clinical Trial Essay

Open Document