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

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





• 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





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





• 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





• 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





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





• 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





• 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





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





• 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





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





• 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





• 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





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





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





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





Documents

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