Presentation of a Sample Case Studies from a Phase 4 Clinical Trial, "Communit-Based Research Assessment Investigating Clobetasol Proplonate 0.05% Spray for the Treatment of Chronic Plaque Psorias - The COBRA Trial"




Kulkarni, Gopal


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Internship Project. Title of the Project. Presentation of Sample Case Studies from phase 4 clinical trial, “Community-Based Research Assessment Investigating Clobetasol Propionate 0.05% Spray for the Treatment of Chronic Plaque Psoriasis- the COBRA trial” Specific Aims. The specific aims of the practicum were to: 1) Select 50 subjects who had photographs available from the Data Listing (database) of the COBRA trial subjects; 2) Collect data for each case from the database provided; 3) Classify the collected data into efficacy, safety, subject satisfaction, compliance and quality of life evaluations; 4) Generate a presentation (slide kit) of the selected case studies for educational and training purposes. Signficance. Case study presentations are a tool to demonstrate the performance of a drug used in a clinical trial. Due to the large scale of the COBRA trial, there was to a need to generate a reference presentation using data belonging to a sample of subjects from the trial. This reference presentation may be useful for educational and training purposes. This chapter describes the process of development of these case study presentations from the data obtained in the COBRA trial.