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What Clinical Research  Means to You
<ul><li>Clinical Research Volunteers  are Medical Heroes </li></ul>
Part 1: What is Clinical Research?
What do we learn from studies? <ul><li>How well does a new drug work or not work? </li></ul><ul><li>Is there a better way ...
What is a clinical trial? <ul><li>Scientific study that answers  a medical question. </li></ul><ul><ul><li>Is a treatment ...
A clinical trial is NOT the same as standard of care <ul><li>Standard of Care </li></ul><ul><ul><li>Routine care </li></ul...
People are different <ul><li>We need all types of volunteers </li></ul>
Clinical trials: a 4 step process <ul><li>Phase 1: safety </li></ul><ul><li>Phase 2: how much to take & side effects </li>...
Clinical trials <ul><li>Clinical Trial Sponsors: </li></ul><ul><ul><ul><li>Government </li></ul></ul></ul><ul><ul><ul><li>...
Part 1 Review <ul><li>1.  What is a clinical trial? </li></ul><ul><ul><li>The same thing as a visit to your doctor </li></...
Part 1 Review <ul><li>2.  What is standard of care? </li></ul><ul><ul><li>Medical treatment that is not the best available...
Part 2: The Research Team and Informed Consent <ul><li>All members of the team are important </li></ul>
Principal Investigator (PI) <ul><li>Like the head coach </li></ul><ul><ul><li>Organizes the study </li></ul></ul><ul><ul><...
Clinical Research Coordinator (CRC) <ul><li>Like the assistant coach </li></ul><ul><ul><li>Handles day-to-day activities <...
Volunteer Protections <ul><li>Like the referees </li></ul><ul><ul><li>Review the study before it starts </li></ul></ul><ul...
Volunteer Protections <ul><ul><li>Institutional Review Boards (IRB) </li></ul></ul><ul><ul><ul><li>Make sure a trial is et...
Volunteer Protections <ul><ul><li>Food and Drug Administration </li></ul></ul><ul><ul><ul><li>Reviews studies </li></ul></...
Volunteers <ul><li>Like the players </li></ul><ul><ul><li>The MOST important team member </li></ul></ul><ul><ul><li>There ...
Friends, family and your supporters <ul><li>Like  the fans </li></ul><ul><ul><li>People to talk to about the study </li></...
Eligibility Criteria <ul><li>Who is the right player for the game? </li></ul>
Informed Consent <ul><ul><li>A process to make sure you understand and agree  to be in the study </li></ul></ul><ul><ul><u...
You have rights and responsibilities <ul><li>To understand the study </li></ul><ul><li>To ask questions and get answers </...
Part 2 Review <ul><li>3. What is the role of the Principal Investigator (PI) in a clinical research study? </li></ul><ul><...
Part 2 Review <ul><li>4. What is the role of the Institutional Review  Board (IRB)? </li></ul><ul><ul><li>Make sure a clin...
Part 2 Review <ul><li>5. What is the role of the Food and Drug Administration (FDA)? </li></ul><ul><ul><li>To keep track o...
Part 2 Review <ul><li>6.  What is informed consent? </li></ul><ul><ul><li>A conversation between you and the study staff  ...
Part 3: Should I or Shouldn’t I? <ul><li>What’s right for me? </li></ul>
Understanding the study design <ul><li>Study Methods </li></ul><ul><ul><li>Randomized </li></ul></ul><ul><ul><li>Blinded  ...
Possible benefits <ul><li>Access to new therapies  </li></ul><ul><li>Advance science and help others in the future </li></...
Possible risks <ul><li>Physical  </li></ul><ul><li>Emotional  </li></ul><ul><li>Financial </li></ul><ul><li>Privacy and co...
Things to consider… <ul><li>All your doctors need to know you are  in a clinical trial </li></ul><ul><li>This will require...
Education before participation <ul><li>Do your homework </li></ul><ul><li>Take your time </li></ul><ul><li>Ask questions <...
Your  decision at every step
Part 3 Review <ul><li>7.  What is a placebo? </li></ul><ul><ul><li>A harmless pill  </li></ul></ul><ul><ul><li>The study d...
Part 3 Review  <ul><li>8.  A person in a randomized trial will:  </li></ul><ul><ul><li>Always get the study drug </li></ul...
Part 3 Review <ul><li>9. What are the benefits of taking part  in a clinical trial? </li></ul><ul><ul><li>Receive access t...
Part 3 Review  <ul><li>10.  What are the risks? </li></ul><ul><ul><li>You may not get better </li></ul></ul><ul><ul><li>Yo...
Part 3 Review <ul><li>11. Who makes the final decision to take  part in a clinical trial? </li></ul><ul><ul><li>Your  doct...
Want to learn more? <ul><li>Your doctor </li></ul><ul><li>Advocacy groups </li></ul><ul><li>Pharmaceutical and biotechnolo...
Thank you… <ul><li>Thank  you… </li></ul><ul><li>to the millions of people who give  the gift of participation in clinical...
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What Clinical Research Means to You: San Francisco AWARE FOR ALL

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Bill Balke, Program Director of CTSI-Clincial Research Services, presents at 2011 San Francisco AWARE FOR ALL

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What Clinical Research Means to You: San Francisco AWARE FOR ALL

  1. 1. What Clinical Research Means to You
  2. 2. <ul><li>Clinical Research Volunteers are Medical Heroes </li></ul>
  3. 3. Part 1: What is Clinical Research?
  4. 4. What do we learn from studies? <ul><li>How well does a new drug work or not work? </li></ul><ul><li>Is there a better way to treat a disease like diabetes? </li></ul><ul><li>How do genes affect illness? </li></ul><ul><li>Does where people live change their health? </li></ul>
  5. 5. What is a clinical trial? <ul><li>Scientific study that answers a medical question. </li></ul><ul><ul><li>Is a treatment safe? </li></ul></ul><ul><ul><li>Does it improve a certain medical condition? </li></ul></ul><ul><ul><li>Does it have side effects? </li></ul></ul><ul><ul><li>How should people take it? </li></ul></ul><ul><ul><li>Is it any better than medicines that are already on the market? </li></ul></ul>
  6. 6. A clinical trial is NOT the same as standard of care <ul><li>Standard of Care </li></ul><ul><ul><li>Routine care </li></ul></ul><ul><ul><li>Has been tested and approved </li></ul></ul><ul><ul><li>Works for most people </li></ul></ul><ul><li>Clinical Trial </li></ul><ul><ul><li>Looks for answers to a question </li></ul></ul><ul><ul><li>Still learning how it works </li></ul></ul>
  7. 7. People are different <ul><li>We need all types of volunteers </li></ul>
  8. 8. Clinical trials: a 4 step process <ul><li>Phase 1: safety </li></ul><ul><li>Phase 2: how much to take & side effects </li></ul><ul><li>Phase 3: does it work better than the current drug and how does it work in different groups of people </li></ul><ul><li>Phase 4: real world experience </li></ul>
  9. 9. Clinical trials <ul><li>Clinical Trial Sponsors: </li></ul><ul><ul><ul><li>Government </li></ul></ul></ul><ul><ul><ul><li>Academic Medical Centers </li></ul></ul></ul><ul><ul><ul><li>Pharmaceutical Companies </li></ul></ul></ul><ul><ul><ul><li>Biotechnology Companies </li></ul></ul></ul><ul><ul><ul><li>Medical Device Companies </li></ul></ul></ul>
  10. 10. Part 1 Review <ul><li>1. What is a clinical trial? </li></ul><ul><ul><li>The same thing as a visit to your doctor </li></ul></ul><ul><ul><li>A scientific study that answers a medical question </li></ul></ul><ul><ul><li>A way to get medicines not carried by your pharmacy </li></ul></ul><ul><ul><li>Not sure </li></ul></ul>
  11. 11. Part 1 Review <ul><li>2. What is standard of care? </li></ul><ul><ul><li>Medical treatment that is not the best available </li></ul></ul><ul><ul><li>The only treatment that can help when you are sick </li></ul></ul><ul><ul><li>Routine treatment that has already been tested and approved </li></ul></ul><ul><ul><li>Not sure </li></ul></ul>
  12. 12. Part 2: The Research Team and Informed Consent <ul><li>All members of the team are important </li></ul>
  13. 13. Principal Investigator (PI) <ul><li>Like the head coach </li></ul><ul><ul><li>Organizes the study </li></ul></ul><ul><ul><li>Records and studies the data </li></ul></ul><ul><ul><li>Directs the study staff </li></ul></ul><ul><ul><li>Follows a protocol (play book) </li></ul></ul>
  14. 14. Clinical Research Coordinator (CRC) <ul><li>Like the assistant coach </li></ul><ul><ul><li>Handles day-to-day activities </li></ul></ul><ul><ul><li>Works with principal investigator (PI) </li></ul></ul><ul><ul><li>Main contact for volunteers </li></ul></ul>
  15. 15. Volunteer Protections <ul><li>Like the referees </li></ul><ul><ul><li>Review the study before it starts </li></ul></ul><ul><ul><li>Make sure the team follows the rules </li></ul></ul><ul><ul><li>Keep you safe and informed </li></ul></ul>
  16. 16. Volunteer Protections <ul><ul><li>Institutional Review Boards (IRB) </li></ul></ul><ul><ul><ul><li>Make sure a trial is ethical and fair </li></ul></ul></ul><ul><ul><ul><li>Make sure there is not too much risk for volunteers </li></ul></ul></ul><ul><ul><ul><li>Researchers must inform the IRB if there are any changes to the study plan </li></ul></ul></ul><ul><ul><ul><li>Or if the volunteers experience serious injuries or side effects </li></ul></ul></ul><ul><ul><ul><li>Can end a trial if it feels volunteers are not safe </li></ul></ul></ul>
  17. 17. Volunteer Protections <ul><ul><li>Food and Drug Administration </li></ul></ul><ul><ul><ul><li>Reviews studies </li></ul></ul></ul><ul><ul><ul><li>Inspects research centers </li></ul></ul></ul><ul><ul><ul><li>Monitors research groups </li></ul></ul></ul><ul><ul><ul><li>Has the final say as to whether or not a treatment is approved </li></ul></ul></ul>
  18. 18. Volunteers <ul><li>Like the players </li></ul><ul><ul><li>The MOST important team member </li></ul></ul><ul><ul><li>There are lots of studies to choose from </li></ul></ul><ul><ul><li>Healthy volunteers needed too! </li></ul></ul>
  19. 19. Friends, family and your supporters <ul><li>Like the fans </li></ul><ul><ul><li>People to talk to about the study </li></ul></ul><ul><ul><li>Help you ask questions about the study </li></ul></ul><ul><ul><li>Support you during the study </li></ul></ul>
  20. 20. Eligibility Criteria <ul><li>Who is the right player for the game? </li></ul>
  21. 21. Informed Consent <ul><ul><li>A process to make sure you understand and agree to be in the study </li></ul></ul><ul><ul><ul><li>A conversation between you and the study staff </li></ul></ul></ul><ul><ul><ul><li>A form to sign </li></ul></ul></ul><ul><ul><ul><li>Answers all your questions </li></ul></ul></ul>
  22. 22. You have rights and responsibilities <ul><li>To understand the study </li></ul><ul><li>To ask questions and get answers </li></ul><ul><li>To quit at any time </li></ul>
  23. 23. Part 2 Review <ul><li>3. What is the role of the Principal Investigator (PI) in a clinical research study? </li></ul><ul><ul><li>Organizes the study </li></ul></ul><ul><ul><li>Records and studies the data </li></ul></ul><ul><ul><li>Directs the study staff </li></ul></ul><ul><ul><li>All of the above </li></ul></ul>
  24. 24. Part 2 Review <ul><li>4. What is the role of the Institutional Review Board (IRB)? </li></ul><ul><ul><li>Make sure a clinical trial is ethical and fair </li></ul></ul><ul><ul><li>Make sure volunteers are not exposed to too much risk </li></ul></ul><ul><ul><li>Ends the trial if volunteers are not safe </li></ul></ul><ul><ul><li>All of the above </li></ul></ul>
  25. 25. Part 2 Review <ul><li>5. What is the role of the Food and Drug Administration (FDA)? </li></ul><ul><ul><li>To keep track of research studies using new drugs </li></ul></ul><ul><ul><li>To Inspect research sites </li></ul></ul><ul><ul><li>Gives the final approval for a drug to be used in the USA </li></ul></ul><ul><ul><li>All of the above </li></ul></ul>
  26. 26. Part 2 Review <ul><li>6. What is informed consent? </li></ul><ul><ul><li>A conversation between you and the study staff </li></ul></ul><ul><ul><li>A process to make sure you understand and agree to be in the study </li></ul></ul><ul><ul><li>A form that contains important information about your rights in the clinical trial </li></ul></ul><ul><ul><li>All of the above </li></ul></ul>
  27. 27. Part 3: Should I or Shouldn’t I? <ul><li>What’s right for me? </li></ul>
  28. 28. Understanding the study design <ul><li>Study Methods </li></ul><ul><ul><li>Randomized </li></ul></ul><ul><ul><li>Blinded </li></ul></ul><ul><ul><li>Placebo </li></ul></ul>
  29. 29. Possible benefits <ul><li>Access to new therapies </li></ul><ul><li>Advance science and help others in the future </li></ul><ul><li>The research staff will observe your health closely </li></ul>
  30. 30. Possible risks <ul><li>Physical </li></ul><ul><li>Emotional </li></ul><ul><li>Financial </li></ul><ul><li>Privacy and confidentiality </li></ul>
  31. 31. Things to consider… <ul><li>All your doctors need to know you are in a clinical trial </li></ul><ul><li>This will require your time and commitment </li></ul><ul><li>The clinical trial could end at any time </li></ul>
  32. 32. Education before participation <ul><li>Do your homework </li></ul><ul><li>Take your time </li></ul><ul><li>Ask questions </li></ul>
  33. 33. Your decision at every step
  34. 34. Part 3 Review <ul><li>7. What is a placebo? </li></ul><ul><ul><li>A harmless pill </li></ul></ul><ul><ul><li>The study drug </li></ul></ul>
  35. 35. Part 3 Review <ul><li>8. A person in a randomized trial will: </li></ul><ul><ul><li>Always get the study drug </li></ul></ul><ul><ul><li>Always get the placebo (harmless pill) </li></ul></ul><ul><ul><li>Get either the study drug or placebo (harmless pill) by chance </li></ul></ul>
  36. 36. Part 3 Review <ul><li>9. What are the benefits of taking part in a clinical trial? </li></ul><ul><ul><li>Receive access to new treatments </li></ul></ul><ul><ul><li>Help people in the future </li></ul></ul><ul><ul><li>Research staff will observe your health closely </li></ul></ul><ul><ul><li>All of the above </li></ul></ul>
  37. 37. Part 3 Review <ul><li>10. What are the risks? </li></ul><ul><ul><li>You may not get better </li></ul></ul><ul><ul><li>Your condition could get worse </li></ul></ul><ul><ul><li>Discomforts </li></ul></ul><ul><ul><li>All of the above </li></ul></ul>
  38. 38. Part 3 Review <ul><li>11. Who makes the final decision to take part in a clinical trial? </li></ul><ul><ul><li>Your doctor </li></ul></ul><ul><ul><li>The research team </li></ul></ul><ul><ul><li>You </li></ul></ul>
  39. 39. Want to learn more? <ul><li>Your doctor </li></ul><ul><li>Advocacy groups </li></ul><ul><li>Pharmaceutical and biotechnology companies </li></ul><ul><li>The Internet </li></ul><ul><ul><li>www.clinicaltrials.gov </li></ul></ul><ul><ul><li>www.centerwatch.com </li></ul></ul><ul><ul><li>www.researchmatch.org </li></ul></ul><ul><ul><li>www.ciscrp.org </li></ul></ul>
  40. 40. Thank you… <ul><li>Thank you… </li></ul><ul><li>to the millions of people who give the gift of participation in clinical trials each year and tothe rest of us who admire them for doing so. </li></ul>

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