Friday, 23 October 2015

A Critical Evaluation of Clinical Research Study Designs



Unfortunately we are unable to provide accessible alternative text for this. If you require assistance to access this image, please contact help@nature.com or the author Prior to starting any clinical research, an investigator must determine the appropriate study design to answer the question at hand. Selecting the correct study type also depends on ethical considerations, disease of interest, and the resources available. A well-designed study will clearly identify an exposure and an outcome in an objective, quantifiable manner to answer a defined hypothesis. After thorough data analysis and discussion of the results, the study will ideally prompt further research on the subject. Understanding the various indications for different study designs is important not only for devising one’s own study but also for critically reviewing the literature. This article outlines frequently encountered study designs in clinical research and their respective strengths and drawbacks.

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Cancer 2015: A longitudinal whole-of-system study of genomic cancer medicine

Genomic cancer medicine promises revolutionary change in oncology. The impacts of ‘personalized medicine’, based upon a molecular classification of cancer and linked to targeted therapies, will extend from individual patient outcomes to the health economy at large. To address the ‘whole-of-system’ impact of genomic cancer medicine, we have established a prospective cohort of patients with newly diagnosed cancer in the state of Victoria, Australia, about whom we have collected a broad range of clinical, demographic, molecular, and patient-reported data, as well as data on health resource utilization. Our goal is to create a model for investigating public investment in genomic medicine that maximizes the cost:benefit ratio for the Australian community at large.

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