Secondary objectives and endpoints

A given trial is conducted to collect optimum quality data with which to answer an identified and important research question. The data collected are intended to provide the most accurate answers to the research questions posed. A study protocol will often include both primary and secondary objectives, and also the associated primary and secondary endpoints. 

PTCA). The primary objective was to evaluate the occurrence of major adverse cardiac events (MACE) [death, recurrent myocardial infarction (Ml), or clinically driven target lesion revascularization] 30 days postprocedure. The secondary objectives were to evaluate the binary restenosis, incidence of (sub)acute stent thrombosis at 30 days follow-up, MACE at 6 and 12 months and the QCA endpoints at 6 months. This study was designed to allow a comparison with the patient population and the results of a larger randomized DISTINCT (BiodivYsio stent in controlled clinical trial) study previously conducted in the U.S. 

The analysis plan should also specify the hypothesis and objectives of the study, define the primary and secondary endpoints, and describe how the endpoints will be constructed (e.g., multiplying resource counts measured in the trial times a set of unit costs measured outside the trial). In addition, the analysis plan should identify the potential covariables that will be used in the analysis and specify the time periods of interest (e.g., costs and clinical outcomes at... 

How can we choose primary and secondary endpoints in line with the clinical objectives for the trial ... 

Clear definition and delineation of the primary and secondary endpoints and how these link with the objectives of the trial... 

The protocol must contain a clear statement of the objectives of the investigation (primary and secondary endpoints) and the methods of analysis to be used. The various sections may be written by the appropriate team members and assembled by the clinical representative who is the protocol author. Once the protocol is... 

For each phase of drug development, the study design specifies the objectives, the enrollment procedure, the treatment plan over the study, data collection including the definition of primary and secondary endpoints, and data analysis. 

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