Introductiontoclinicalresearch.pptVIP

Introduction to clinical research-Publish or Perish- 林隆堯 Long-Yau Lin MD, MPH, ScD Chung-Shan Medical University Considerations of study design 1. The question to be answered or hypothesis to be answered 2. Subjects 3. Research models and methods 4. Methods of data acquisition 5. Type of data analysis 6. Data reporting Steps in Clinical Research 1. Develop a question engendered and/or motivated by experience. 2. State the question as a testable hypothesis ( if you cannot do it, you still do not have a good question). 3. Search the literature to see if it has been answered totally or partially 4. Revise ( perhaps) the question and hypothesis based on your reading of the literature. Step in Clinical Research-continued 5. Determine what tools, materials, personnel, time, and so forth are necessary to obtain and analyzed the data based on your reading of the literature. 6. Given the preceding requirements, is the study feasible? 7. Revise ( perhaps) the question and hypothesis and/or alter the variables according to your resources and time. 8. Choose the appropriate subjects ( including controls, if appropriate) from whom data on the variables can be obtained. Steps in Clinical Research-continued 9. Revised ( perhaps) the question, hypothesis,and variables to match the subjects to whom you have access. 10. If you are still interested ( and this is what separates the true clinical researchers from the dabblers), devise your methods to collect the data from subjects. 11. Discuss your proposed study with a biostatistician or some experienced epidemiologist in clinical research. 12. Only now should you collect the data. Unfortunately, many novices begin this step too soon thereby compromising the study’s worth. Steps in Clinical Research-continued 13. Analyze the data, with the help of a biostatistician. 14. Write it up for publication ( this is what separates the academic from the nonacademic clinical researchers). 15. After it is accepted ( and it might take several att