What is Clinical Research?

What is Clinical Research?

SEPA Skills CurriculumCornell Note Taking

SEPA Skills CurriculumCornell Note Taking

Clinical Research: What is the Goal?

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

• 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

• 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

• 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?

Clinical Research: Who Benefits?

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

• 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

• 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

• 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?

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

• 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

• 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

• 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?

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

• 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

• 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 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

• 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

• 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

• 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

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

• 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?

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

• 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 EndThe 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

• 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

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