What is Clinical Research?

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What is Clinical Research?

• SEPA Skills Curriculum
• Cornell Note Taking

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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

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• 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

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• 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

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Clinical Research Who Benefits?

• Society benefits from clinical research because
  our understanding of medical treatments and
  health improves

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• 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

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

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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

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• 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

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• 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

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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

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• 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

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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

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• 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

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

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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

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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

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The End

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