Ethics of Clinical Trials

1
Ethics of Clinical Trials

• Janet Leung
• Sophomore, Course 9
• 5.22 Biotechnology and Engineering
• Professors Essigmann and Langer
• May 1, 2003

2
Overview

• What are clinical trials?
• Development of ethical code
• What makes trials ethical?
• Further research
• Questions

3
What Are Clinical Trials?

• Occurs after extensive laboratory testing in the
  treatment development process
• Determines whether new treatments are safe,
  better than the current ones
• Is the fastest way to find treatments that work

http//www.nlm.nih.gov/medlineplus/tutorials/clini
caltrials/hc019101.html
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What Are Clinical Trials? (cont)

• Study is carefully designed to answer the
  research questions posed and protect participants
• Regulatory agencies and ethics committees
• Institutional Review Boards
• Benefits and risks of being in a clinical trial

http//www.nlm.nih.gov/medlineplus/tutorials/clini
caltrials/hc019101.html
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Phases of Clinical Trials
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Phases of Clinical Trials (cont.)
Hall, John. The Drug Development Process.
http//clinicaltrials.gov/ct/gui/info/whatisjse
ssionid FBB62CC45DC724E2251E4920F86084CCphases
Guidant
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Development of Ethical Guidelines
http//www.patientcenters.com/trials/news/ethics_o
f.html Emanuel, Ezekiel, et al. What Makes
Clinical Research Ethical? Talbot, David and
Joan Perou. Ethical Issues
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What Makes Clinical Trials Ethical?

• Social or scientific value
• Scientific validity independent review
• Favorable risk-benefit ratio
• Fair subject selection
• Informed consent
• Respect for potential and enrolled subjects

Looking at Sirolimus- and Paclitaxel-eluting
stents
Emanuel, Ezekiel, et. al. What Makes Clinical
Research Ethical?
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Social or Scientific Value

• Finite resources, especially funding and
  volunteers
• Experiments that do
• Generalizable results
• Strong hypotheses
• Unique

Emanuel, Ezekiel, et. al. What Makes Clinical
Research Ethical? Sung, Nancy, et. al. Central
Challenges Facing the National
Clinical Research Enterprise.
10
Scientific Validity Independent Review

• Methodical, rigorous
• Investigators have multiple, sometimes competing
  interests
• Adverse Event Reports to sponsors and IRB (IEC)
• Data monitoring committees
• Series of sirolimus and paclitaxel clinical
  trials in peer-reviewed journals, regardless of
  results
• Sirolimus and paclitaxel after negative results

Callahan, Timothy. Research Ethics. Emanuel,
Ezekiel, et. al. What Makes Clinical Research
Ethical? Virmani, Renu. Mechanism of Late
In-Stent Restenosis . . .
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Regarding Subjects

• Favorable risk-benefit ratio
• To subject
• To society
• Fair subject selection
• Consider scientific objectives, not just
  convenience
• Exclude those who are at higher risk of being
  harmed
• Investigators agreed on not using critical cases

Schwartz, Robert, et. al. Drug-Eluting Stents in
Preclinical Sudies Emanuel, Ezekiel, et. al.
What Makes Clinical Research Ethical?
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Informed consent

• The most important ethical consideration?
• Components
• Volunteer
• Understanding
• Disclosure
• Signed agreements
• Patients especially tend to be well-informed
  explain terminology, pamphlets

Callahan, Timothy. Research Ethics. Emanuel,
Ezekiel, et. al. What Makes Clinical Research
Ethical?
13
Respect for potential and enrolled subjects

• Even if they refuse
• Confidentiality
• Allow them to withdrawal from program
• Keep them informed of developments, carefully
  monitor

Callahan, Timothy. Research Ethics. Emanuel,
Ezekiel, et. al. What Makes Clinical Research
Ethical?
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Conclusions

• Clinical trials are necessary but need to be
  carefully monitored
• In general, nowadays clinical trials in the
  United States are ethical
• There needs to be a single, legally-binding
  ethical guideline
• Sirolimus and paclitaxel need to be tracked
  longer

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Further Research
i.e. the next forty minutes of the presentation
Joking

• Possibly animal testing
• More info on drug-eluting stent clinical trials

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Sources

• Callahan, Timothy. Research Ethics. University
  of Washington School of
• Medicine Ethics in Medicine. 31 March 2003.
  lthttp//eduserv.hscer.washington.edu/bioethics/to
  pics/resrch.htmlgt
• Clinical Trial Ethics. Cancer Clinical Trials
  Center. 17 March 2003
• lthttp//www.patientcenters.com/trials/news/ethic
  s_of.htmlgt.
• Guidant
• Emanuel, Ezekiel, David Wendler, and Christine
  Grady. What Makes Clinical Research Ethical?
  Journal of the American Medical Association, 283
• 2701-2711.
• Hall, John. The Drug Development Process. The
  Institute of Clinical Research
• Principles of Clinical Research. Ed. Ignazio Di
  Giovanna and Gareth
• Hayes. Petersfield Wrightson Biomedical
  Publishing Ltd, 2001. 1-16.
• National Library of Medicine. Clinical Trials.
  3 March 2003.
• lthttp//www.nlm.nih.gov/medlineplus/tutorials/cl
  inicaltrials/
• hc019101.html.gt.

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Sources (cont.)

• National Library of Medicine. An Introduction to
  Clinical Trials.
• ClinicalTrials.gov. 10 March 2003.
  lthttp//clinicaltrials.gov/ct/gui/
• info/whatisjsessionidFBB62CC45DC724E2251E4920F
  86084CC
• phases
• Sung, Nancy, et. al. Central Challenges Facing
  the National Clinical Research
• Enterprise. Journal of the American Medical
  Association, 289
• 1278-1287.
• Schwartz, Robert, et. al. Drug-Eluting Stents in
  Preclinical Studies. Circulation,
• 106 1867.
• Talbot, David and Joan Perou. Ethical Issues.
  The Institute of Clinical Research Principles of
  Clinical Research. Ed. Ignazio Di Giovanna and
  Gareth Hayes. Petersfield Wrightson Biomedical
  Publishing Ltd, 2001. 63-83.
• Virmani, Reny, et. al. Mechanism of Late
  In-Stent Restenosis after Implantation
• of a Paclitaxel Derivate-Eluting Polymer Stent
  System in Humans. Circulation, 106 2649.

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Questions?
Im paying attention, I swear zzz