tailieunhanh - MEDICAL STATISTICS - PART 3

Thử nghiệm lâm sàng: Một nghiên cứu tương lai liên quan đến đối tượng con người được thiết kế để xác định hiệu quả của một điều trị, một thủ tục phẫu thuật, hoặc một chế độ điều trị dùng cho bệnh nhân với một căn bệnh cụ thể. | Clinical endpoint A characteristic or variable that reflects how a patient feels functions or survives. True clinical endpoints maybe difficult to measure or maybe affected by concomitant medications or competing risks from comorbidity in which case a surrogate endpoint may be preferred. Clinical epidemiology The application of methods derived from epidemiology and other fields to the study of clinical phenomena particularly diagnosis treatment decisions and outcomes. Fletcher R. H. Fletcher S. W. and Wagner E. H. 1996 Clinical Epidemiology The Essentials 3rd edn Williams and Wilkins Baltimore. Clinical prior See prior distributions. Clinical trial A prospective study involving human subjects designed to determine the effectiveness of a treatment a surgical procedure or a therapeutic regimen administered to patients with a specific disease. There is a well-established categorization of such studies into the following types Phase I study Initial clinical trial on a new compound usually conducted among healthy volunteers with a view to assessing safety. Phase II study Once a drug has been established as safe in a phase I study the next stage is to conduct a clinical trial in patients to determine the optimum dose and to assess the efficacy of the compound. Phase III study Large multicentre comparative clinical trials to demonstrate the safety and efficacy of the new treatment with respect to the standard treatments available. These are the studies that are needed to support product licence applications. Phase IVstudy Studies conducted after a drug is marketed to provide additional details about its safety efficacy and usage profile. See also high-risk trials and vulnerable-population trials. Everitt B. S. and Wessely S. 2004 Clinical Trials in Psychiatry Oxford University Press Oxford. Clinical trial About 8000 trials are carried out each year. The randomized clinical trial is probably the greatest contribution by statisticians to medical research. Clinical trial .