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SHOULD I PARTICIPATE IN A
CLINICAL TRIAL?
GARY C. PIEN, MD/PhD
Allergist/Immunologist
SMG Research Director
June 5, 2013
OBJECTIVES
• Understand what is a clinical trial
• Examine the role of medical research and clinical trials in
developing new therapies
• Review the drug development process
• Discuss ethical and scientific safeguards to protect research
participants
• Highlight ways to participate in medical research
WHAT IS A CLINICAL TRIAL?
• medical research
• novel methods to diagnose, prevent, or treat diseases
 new drugs
 new combinations of drugs
 new indications of an existing drug
 new surgical techniques or medical devices
 new test for diagnosing disease or risk of disease
 establishing new guidelines or recommendations
• goal is to determine if new intervention is safe and effective
http://www.nih.gov/health/clinicaltrials/basics.htm
TYPES OF CLINICAL TRIALS
NATURAL HISTORY
• how does a disease change, progress, or develop over time?
PREVENTION
• how to prevent a disease from developing or recurring?
SCREENING OR DIAGNOSTIC
• how to detect a medical condition or diagnose a particular disease
QUALITY OF LIFE
• measure ways to improve comfort and quality of life with a chronic illness
TREATMENT
• testing a new medication, procedure, or device
http://www.nih.gov/health/clinicaltrials/basics.htm
CLINICAL TRIAL “PHASES”
PHASE I
• healthy human volunteers (20-80)
• establish safety and side effects
• evaluate drug absorption, metabolism, clearance
PHASE II
• first use in patients with disease/medical condition (100-300)
• limited duration, narrow patient criteria
• establish efficacy, short-term safety
http://www.nih.gov/health/clinicaltrials/basics.htm
CLINICAL TRIAL “PHASES”
PHASE III
• confirmation of therapeutic benefit under “real-life” conditions
• 1000-3000 patients
• wider patient criteria
• often multi-center, multi-national, comparative
• longer-term safety, drug interactions, contraindications
PHASE IV
• after-market trials
• long-term safety data
• identify rare side effects
http://www.nih.gov/health/clinicaltrials/basics.htm
HOW A DRUG COMES TO BE
DiMasi et al, 2003, Journal of Health Economics 22: 151–185.
Preclinical
1 - 6 yrs
1 in 8 move on
Drug discovery
and
development
HOW A DRUG COMES TO BE
DiMasi et al, 2003, Journal of Health Economics 22: 151–185.
Preclinical
1 - 6 yrs
1 in 8 move on
Drug discovery
and
development
http://sydney.edu.au/bmri/research/brain-drug-discovery/index.php
HOW A DRUG COMES TO BE
DiMasi et al, 2003, Journal of Health Economics 22: 151–185.
Clinical
Phase I
• safety
• $15 million
• 22 months
Phase II
• safety,
dosing,
efficacy
• $23 million
• 26 months
Phase III
• safety,
efficacy, side
effects
• $87 million
• 31 months
Investigational
new drug
application
6 - 11 yrs
30% 14% 9%40%
Preclinical
1 - 6 yrs
1 in 8 move on
Drug discovery
and
development
HOW A DRUG COMES TO BE
DiMasi et al, 2003, Journal of Health Economics 22: 151–185.
Clinical
Phase I
• safety
• $15 million
• 22 months
Phase II
• safety,
dosing,
efficacy
• $23 million
• 26 months
Phase III
• safety,
efficacy, side
effects
• $87 million
• 31 months
Investigational
new drug
application
6 - 11 yrs
30% 14% 9%40%
Approval
1-2 yrs
8%
New drug
application
Market
11-14 yrs
Phase IV
also post-
market
surveillance
Preclinical
1 - 6 yrs
1 in 8 move on
Drug discovery
and
development
PROTECTION OF RESEARCH PATIENTS
http://www.mastercontrol.com/newsletter/good-clinical-practices-review-application.html
PROTECTION OF RESEARCH PATIENTS
DECLARATION OF HELSINKI - 1975
• protect health, dignity, integrity, privacy of volunteers
• study must conform to accepted scientific principles
• research protocol must be established and followed
• protocol must be approved by independent ethics committee
• benefits must outweigh risks
• participation must be voluntary, without duress
• informed consent must be obtained
• privacy and confidentiality must be protected
http://www.wma.net/en/30publications/10policies/b3/
PROTECTION OF RESEARCH PATIENTS
BELMONT REPORT - 1979
• Smithsonian Institute
• respect for persons – autonomy of patients
• beneficence – protection from harm, ensure well-being of patients
• justice – results should benefit all (not just those who can afford it, etc)
COMMON RULE - 1981
• US federal policy derived from Declaration of Helsinki
• enforces compliance by research bodies
• safeguards informed consent
• provides for IRB regulations
• establishes protections for vulnerable populations (prisoners, children,
pregnant women)
http://www.mastercontrol.com/newsletter/good-clinical-practices-review-application.html
PROTECTION OF RESEARCH PATIENTS
ICH
• International Conference on Harmonisation
• brings together regulatory bodies of Japan, Europe and US
• develop standards for ethical and scientific research
• quality, safety, efficacy, regulatory issues
• reduce duplicate testing
GCP
• Good Clinical Practices
• human subject protection – patient rights, integrity, confidentiality
• standards for design, conduct, performing, monitoring, recording data
http://ichgcp.net/2-the-principles-of-ich-gcp-2
http://www.wma.net/en/30publications/10policies/b3/
PROTECTION OF RESEARCH PATIENTS
IRB
• institutional review board
• doctors, scientists, lay people
• scientific, ethical, and regulatory oversight
• ensure that rights and welfare of participants are protected
• appropriate recruitment population?
• how are patients recruited?
• adequate disclosure and informed consent?
• are risks too great?
http://www.fda.gov/forconsumers/consumerupdates/ucm134723.htm
PROTECTION OF RESEARCH PATIENTS
FDA
• Food and Drug Administration
• has authority over clinical trials
• inspects and audit research sites
• ensures rights and welfare of participants
• reviews data quality and integrity
http://www.fda.gov/forconsumers/consumerupdates/ucm134723.htm
PROTECTION OF RESEARCH PATIENTS
INFORMED CONSENT
• disclose purpose and protocol for study
• adequate information for potential volunteers to decide
whether to enroll
• Q&A opportunity for investigator and patient
• no obligation to join a study
• consent must be written
• consent may be withdrawn at any time
http://www.fda.gov/forconsumers/consumerupdates/ucm134723.htm
http://ori.dhhs.gov/education/products/RCRintro/c03/0%20c3.html
MEMBERS OF THE RESEARCH TEAM
PATIENT
Clinical
Research Coordinator
Principal Investigator
Sub-investigator
Private
physician
Clinical research associate
Study monitor
Contract
research organization
Study sponsorIRB FDA
CONSIDERATIONS BEFORE ENROLLING
RISKS
• potential side effects from treatment (may be minor to life-threatening)
• may be assigned to a placebo control group
• impact on daily activities (time commitment, etc)
BENEFITS
• access to new treatments before they are widely available
• regular and careful medical follow-up with research team during trial
• help contribute to medical science
• play more active role in one’s medical care
• results of the study may benefit other people and future generations
http://www.nih.gov/health/clinicaltrials/basics.htm
QUESTIONS TO ASK
THE STUDY
• what is the purpose of the trial?
• why do we think this new treatment will work or help?
PARTICIPATION
• what tests or procedures are required during the study?
• how do these tests/procedures differ from standard treatment?
• who will be in charge of my care?
RISKS AND BENEFITS
• benefits to me?
• what are the chances of side effects?
• how serious are those potential side effects?
• are there other options to treat my condition?
http://www.nih.gov/health/clinicaltrials/basics.htm
QUESTIONS TO ASK
QUALITY OF LIFE
• how will this trial impact my daily living?
• how long will the study last?
• what are my responsibilities?
• can I take other medications during the trial?
COST
• will I have to pay for any part of the trial?
• will my health insurance cover any part of the costs?
• are there any travel expenses?
• is there compensation for my participation?
http://www.nih.gov/health/clinicaltrials/basics.htm
REASONS FOR ENROLLING (OR NOT)
ENROLL
• a trusted physician
recommended study
• additional attention and care
through trial participation
• encouraged by friends/family
• altruism
• (desire to live)
DECLINE
• anxiety about randomization
• worry not best treatment
• logistical difficulties
• concerned about side effects
• friends/family against study
Albrecht et al, 2003, Journal of Cancer Educ 18: 210–214.
ADDITIONAL RESOURCES
http://clinicalresearchtrials.nih.gov
http://www.researchmatch.org
http://www.clinicaltrials.gov
RESEARCH AT SMG
CURRENT
• Breast cancer
• Breast implants
• Colorectal cancer
• Dust mite allergies
• Osteoporosis
• Overactive bladder
PAST
• Diabetes
• Prostate cancer
• Rheumatoid arthritis
• Tinnitus
THANK YOU!
ETHICAL ATROCITIES
WORLD WAR II
• Nazi experimentation on human prisoners
 freezing, poison, chemical warfare, etc
 tried at Nuremberg
• Imperial Japanese Army experimented on coerced humans
 biological warfare agents
 offered immunity by General MacArthur for exclusive access to data
TUSKEGEE SYPHILIS
• compared effects of treating vs no treatment for syphilis
• involved impoverished African-American men
• not given informed consent
• not informed of diagnosis, placebo treatment, or risks

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Should I Participate in a Clinical Trial?

  • 1. SHOULD I PARTICIPATE IN A CLINICAL TRIAL? GARY C. PIEN, MD/PhD Allergist/Immunologist SMG Research Director June 5, 2013
  • 2. OBJECTIVES • Understand what is a clinical trial • Examine the role of medical research and clinical trials in developing new therapies • Review the drug development process • Discuss ethical and scientific safeguards to protect research participants • Highlight ways to participate in medical research
  • 3. WHAT IS A CLINICAL TRIAL? • medical research • novel methods to diagnose, prevent, or treat diseases  new drugs  new combinations of drugs  new indications of an existing drug  new surgical techniques or medical devices  new test for diagnosing disease or risk of disease  establishing new guidelines or recommendations • goal is to determine if new intervention is safe and effective http://www.nih.gov/health/clinicaltrials/basics.htm
  • 4. TYPES OF CLINICAL TRIALS NATURAL HISTORY • how does a disease change, progress, or develop over time? PREVENTION • how to prevent a disease from developing or recurring? SCREENING OR DIAGNOSTIC • how to detect a medical condition or diagnose a particular disease QUALITY OF LIFE • measure ways to improve comfort and quality of life with a chronic illness TREATMENT • testing a new medication, procedure, or device http://www.nih.gov/health/clinicaltrials/basics.htm
  • 5. CLINICAL TRIAL “PHASES” PHASE I • healthy human volunteers (20-80) • establish safety and side effects • evaluate drug absorption, metabolism, clearance PHASE II • first use in patients with disease/medical condition (100-300) • limited duration, narrow patient criteria • establish efficacy, short-term safety http://www.nih.gov/health/clinicaltrials/basics.htm
  • 6. CLINICAL TRIAL “PHASES” PHASE III • confirmation of therapeutic benefit under “real-life” conditions • 1000-3000 patients • wider patient criteria • often multi-center, multi-national, comparative • longer-term safety, drug interactions, contraindications PHASE IV • after-market trials • long-term safety data • identify rare side effects http://www.nih.gov/health/clinicaltrials/basics.htm
  • 7. HOW A DRUG COMES TO BE DiMasi et al, 2003, Journal of Health Economics 22: 151–185. Preclinical 1 - 6 yrs 1 in 8 move on Drug discovery and development
  • 8. HOW A DRUG COMES TO BE DiMasi et al, 2003, Journal of Health Economics 22: 151–185. Preclinical 1 - 6 yrs 1 in 8 move on Drug discovery and development http://sydney.edu.au/bmri/research/brain-drug-discovery/index.php
  • 9. HOW A DRUG COMES TO BE DiMasi et al, 2003, Journal of Health Economics 22: 151–185. Clinical Phase I • safety • $15 million • 22 months Phase II • safety, dosing, efficacy • $23 million • 26 months Phase III • safety, efficacy, side effects • $87 million • 31 months Investigational new drug application 6 - 11 yrs 30% 14% 9%40% Preclinical 1 - 6 yrs 1 in 8 move on Drug discovery and development
  • 10. HOW A DRUG COMES TO BE DiMasi et al, 2003, Journal of Health Economics 22: 151–185. Clinical Phase I • safety • $15 million • 22 months Phase II • safety, dosing, efficacy • $23 million • 26 months Phase III • safety, efficacy, side effects • $87 million • 31 months Investigational new drug application 6 - 11 yrs 30% 14% 9%40% Approval 1-2 yrs 8% New drug application Market 11-14 yrs Phase IV also post- market surveillance Preclinical 1 - 6 yrs 1 in 8 move on Drug discovery and development
  • 11. PROTECTION OF RESEARCH PATIENTS http://www.mastercontrol.com/newsletter/good-clinical-practices-review-application.html
  • 12. PROTECTION OF RESEARCH PATIENTS DECLARATION OF HELSINKI - 1975 • protect health, dignity, integrity, privacy of volunteers • study must conform to accepted scientific principles • research protocol must be established and followed • protocol must be approved by independent ethics committee • benefits must outweigh risks • participation must be voluntary, without duress • informed consent must be obtained • privacy and confidentiality must be protected http://www.wma.net/en/30publications/10policies/b3/
  • 13. PROTECTION OF RESEARCH PATIENTS BELMONT REPORT - 1979 • Smithsonian Institute • respect for persons – autonomy of patients • beneficence – protection from harm, ensure well-being of patients • justice – results should benefit all (not just those who can afford it, etc) COMMON RULE - 1981 • US federal policy derived from Declaration of Helsinki • enforces compliance by research bodies • safeguards informed consent • provides for IRB regulations • establishes protections for vulnerable populations (prisoners, children, pregnant women) http://www.mastercontrol.com/newsletter/good-clinical-practices-review-application.html
  • 14. PROTECTION OF RESEARCH PATIENTS ICH • International Conference on Harmonisation • brings together regulatory bodies of Japan, Europe and US • develop standards for ethical and scientific research • quality, safety, efficacy, regulatory issues • reduce duplicate testing GCP • Good Clinical Practices • human subject protection – patient rights, integrity, confidentiality • standards for design, conduct, performing, monitoring, recording data http://ichgcp.net/2-the-principles-of-ich-gcp-2 http://www.wma.net/en/30publications/10policies/b3/
  • 15. PROTECTION OF RESEARCH PATIENTS IRB • institutional review board • doctors, scientists, lay people • scientific, ethical, and regulatory oversight • ensure that rights and welfare of participants are protected • appropriate recruitment population? • how are patients recruited? • adequate disclosure and informed consent? • are risks too great? http://www.fda.gov/forconsumers/consumerupdates/ucm134723.htm
  • 16. PROTECTION OF RESEARCH PATIENTS FDA • Food and Drug Administration • has authority over clinical trials • inspects and audit research sites • ensures rights and welfare of participants • reviews data quality and integrity http://www.fda.gov/forconsumers/consumerupdates/ucm134723.htm
  • 17. PROTECTION OF RESEARCH PATIENTS INFORMED CONSENT • disclose purpose and protocol for study • adequate information for potential volunteers to decide whether to enroll • Q&A opportunity for investigator and patient • no obligation to join a study • consent must be written • consent may be withdrawn at any time http://www.fda.gov/forconsumers/consumerupdates/ucm134723.htm http://ori.dhhs.gov/education/products/RCRintro/c03/0%20c3.html
  • 18. MEMBERS OF THE RESEARCH TEAM PATIENT Clinical Research Coordinator Principal Investigator Sub-investigator Private physician Clinical research associate Study monitor Contract research organization Study sponsorIRB FDA
  • 19. CONSIDERATIONS BEFORE ENROLLING RISKS • potential side effects from treatment (may be minor to life-threatening) • may be assigned to a placebo control group • impact on daily activities (time commitment, etc) BENEFITS • access to new treatments before they are widely available • regular and careful medical follow-up with research team during trial • help contribute to medical science • play more active role in one’s medical care • results of the study may benefit other people and future generations http://www.nih.gov/health/clinicaltrials/basics.htm
  • 20. QUESTIONS TO ASK THE STUDY • what is the purpose of the trial? • why do we think this new treatment will work or help? PARTICIPATION • what tests or procedures are required during the study? • how do these tests/procedures differ from standard treatment? • who will be in charge of my care? RISKS AND BENEFITS • benefits to me? • what are the chances of side effects? • how serious are those potential side effects? • are there other options to treat my condition? http://www.nih.gov/health/clinicaltrials/basics.htm
  • 21. QUESTIONS TO ASK QUALITY OF LIFE • how will this trial impact my daily living? • how long will the study last? • what are my responsibilities? • can I take other medications during the trial? COST • will I have to pay for any part of the trial? • will my health insurance cover any part of the costs? • are there any travel expenses? • is there compensation for my participation? http://www.nih.gov/health/clinicaltrials/basics.htm
  • 22. REASONS FOR ENROLLING (OR NOT) ENROLL • a trusted physician recommended study • additional attention and care through trial participation • encouraged by friends/family • altruism • (desire to live) DECLINE • anxiety about randomization • worry not best treatment • logistical difficulties • concerned about side effects • friends/family against study Albrecht et al, 2003, Journal of Cancer Educ 18: 210–214.
  • 24. RESEARCH AT SMG CURRENT • Breast cancer • Breast implants • Colorectal cancer • Dust mite allergies • Osteoporosis • Overactive bladder PAST • Diabetes • Prostate cancer • Rheumatoid arthritis • Tinnitus
  • 26. ETHICAL ATROCITIES WORLD WAR II • Nazi experimentation on human prisoners  freezing, poison, chemical warfare, etc  tried at Nuremberg • Imperial Japanese Army experimented on coerced humans  biological warfare agents  offered immunity by General MacArthur for exclusive access to data TUSKEGEE SYPHILIS • compared effects of treating vs no treatment for syphilis • involved impoverished African-American men • not given informed consent • not informed of diagnosis, placebo treatment, or risks