1. What is Clinical Research? SEPA Skills Curriculum Cornell Note Taking SEPA Skills Curriculum Cornell Note Taking

2. Clinical Research: What is the Goal? Researchers are looking for ways to keep people healthy and cure disease They learn how a healthy body works, investigate the causes for illness

3. Researcher first must test their discoveries on cells in laboratories or doing animal research Finally, and most importantly they test their discoveries on people who are willing to participate in clinical research studies

4. Clinical research uses a systematic approach to answer specific health questions The goal is to discover the causes of disease and to test the safety and effectiveness of new treatments in human subjects

5. Clinical Research: Who Benefits? Society benefits from clinical research because our understanding of medical treatments and health improves

6. Those directly involved in the study could benefit the most by receiving expert medical care Others with the same illness will benefits if the treatments are approved

7. Improves health and well-being for all Longer life and better quality of life for population Benefits outweigh the costs

8. Clinical Research: Why do Tests? Testing is needed to determine safety of treatment The use of a control for comparison tells if outcomes can be attributed to the treatment

9. Rigorous testing process in the United States Phase I, II, and III studies Each new treatment must pass each stage Next, it must be approved by the Food and Drug Administration (FDA) before becoming available to the public

10. Phase I Test the safety Phase II See if the new treatment works Continue to test for safety Phase III Determine if the new treatment works better than the old ones

11. Clinical Research: What has it Discovered? Dates to Ancient Egyptians from 1800 B.C. Aristotle (300 B.C.) used experiments to test ideas By 1600, William Harvey discovered how the human heart works

12. Modern clinical research has make amazing discoveries Treatments of Cancer Imitanib was given after cancerous tumors were removed Those who took imitanib were 15% less likely to have a recurrence of cancer Toenail fungus Healthy Lifestyles

13. Clinical Research: How is it Done? Clinical Researcher starts with a case report Tells others about something unusual with one or more patients Example: wrist injury from videogames

14. Next, researcher produces a larger report call a case series Looks for other reports to corroborate her findings Example: Finding more teenagers who play video games and have wrist injuries

15. Finally, the researcher does an experiment Asks specific questions (Ex: Do videogames cause wrist problems?) Conduct experiment to determine the answer

16. Clinical Research: Sample Size and Repetition Similar observations in many test subjects build confidence in a discovery Repetition of experiment eliminates the effects of random chance

17. Clinical Research: Who does it? Scientists and doctors who are trained in research, labs techs, and nurses Most importantly, VOLUNTEERS agreeing to help make medical history

18. The End Check for your name, date and title on your notes Be sure to fill in the left hand side with specific headings or guiding questions Summarize the notes in a few sentences at the bottom of your page