如何撰写临床研究计画书.PDFVIP

如何撰寫臨床研究計畫書 Chun-Jen Liu (劉俊人) M.D., Ph.D. Graduate Institute of Clinical Medicine Department of Internal Medicine And Hepatitis Research Center National Taiwan University Hospital Outlines  Aims of clinical study  Types of clinical study – Observational – Interventional  Key issues in designing study  Essential elements of a successful proposal – Novelty – Feasibility  Conclusions Proposal/Research  From question  To conclusions Questions you want to ask?  Abnormality Sick or well?  Frequency How often  Diagnosis How accurate  Cause What condition leads to disease?  Risk Factors associated with disease?  Prognosis Consequences of disease?  Treatment How treatment changes course?  Prevention Does an intervention prevent dx?  Cost How much will care cost? Before studying, consider…  Why does the topic interest YOU?  Choose a focus  What was thought/known/done before this work?  How does new data change thinking, or support current paradigms, or open new avenues or research? Questions to ask before a study…  Is the study question relevant?  Does the study add anything new?  What type of research question?  Will the study design be appropriate for the question?  Do study methods address potential sources of bias?  Does the study test a stated hypothesis?  Will the statistical analyses be performed correctly?  Are there any conflicts of interest? Propose your hypothesis Strategies to address your hypothesis Strategi