Introduction to Clinical Research - Exam 1
1. clinical research: studies in which people participate as patients or healthy
volunteers
2. What is the purpose of clinical research?: To develop new treatments or
medications, identify causes of an illness, study trends, correlate illness to
genetics.
3. What is the correlating FDA organization in the United Kingdom?: MHRA
4. What is the correlating FDA organization in Europe?: EMA
5. What is the correlating FDA organization in Australia?: TGA
6. What is the drug development process?: synthesis and manufacture of a drug
(white powder) and testing for safety in animals (preclinical testing)
7. What is the clinical research process?: testing for safety and efficacy in
humans (clinical development), submission of data to the FDA (Govt. review),
commercial product available to the public, post-market surveillance
8. Drug discovery occurs:: in the animal laboratory by chance observation or at
the bedside by an acute clinician.
9. The function of the formal controlled clinical trials is to:: separate the relative
handful of discoveries which prove to be true advances in therapy from a legion
of false leads and unverifiable clinical impressions, and to delineate in a scientific
way the extent of and the limitations which attend the effectiveness of drugs.
10. What was the first documentation of a clinical trial?: 605 B.C. - Book of
Daniel; if a vegetarian diet for 10 days was better than King's meat and wine; those
who ate a vegetarian diet were generally healthier after 10 days.
11. What was the first modern documentation of a clinical trial?: 1747 -
James Lind's Scurvy experiment; Lind compared the addition of (1) cider, (2)
sulfuric acid, (3) vinegar, (4) seawater, (5) oranges and lemons and (6) a paste
prepared with barley water to treat scurvy. The patients taking the
orange/lemon addition showed positive results.
12. How many patients were in James Lind's scurvy study?: 12 total with two
patients in each study group
13. FDA Pure Food and Drug Act: 1906 - products could not be sold for
indications outside of the label and prohibited interstate transportation of
unlawful food and drugs; FDA was a policing agency
14. Sulfanilamide Disaster: 1937 - sulfanilamide was dissolved in diethylene
glycol to make it easier to swallow and was marketed to children; over 100
patients died
1/5
, 15. Federal Food, Drug, and Cosmetic Act: 1938 - Required proof of safety
before a new drug could be released and the drug must be labeled with directions
for safe use
16. What changed the FDA from a policing agency to a regulatory agency and
when did this occur?: The Federal Food, Drug, and Cosmetic act in 1938; the
FDA oversees the evaluation of new drugs.
17 Nuremburg Code: 1947 - result of the Nuremburg Trials that occurred during
WWII; it is a set of principles to guide human experimentation, including informed
consent, absence of coercion, sound scientific experimentation and charity to
participants
18. Syphillis Study: 1932-1972 - US Public Health Service conducted studies
on 600 syphilis-positive African Americans to evaluate the effects of syphilis; no
informed consent and some were denied access to penicillin
19. Kefauver-Harris Amendment of 1962: • Also known as the "Drug Efficacy
Amendment".
• Required drug manufacturers to provide proof of the effectiveness and safety
of their drugs before approval .
• Required drug advertising to be more closely regulated and disclose accurate
information about side effects
In response to the thalidomide tragedy
20. Declaration of Helsinki: 1964 - Developed by the World Medical Association;
focuses on the respects and rights of the subjects/patients; the rights of the patients
will not be compromised for the sake of science
21. The Belmont Report: 1979 - Developed in response to the Syphilis Study and
established basic principles for the TX of subjects/patients; respect for persons,
beneficence, and justice
22. FDA and Title 21: 1981 - Establishment of the drug development process and
GxPs; guidelines
23. International Conference on Harmonization (ICH): 1990 - Established
guidelines which unifies countries on the basis of clinical studies
24. What did the ICH do?: Made it unethical to repeat studies with different
patients and exposing them to risk for data that another country may already have
25. What are the seminal documents regarding ethics in clinical trials?:
Nuremburg Code, Declaration of Helsinki, the Belmont Report
26. What does the Nuremburg code consists of and its main points?: 10
points with voluntary consent being absolutely essential, experiment cannot be
procured by other means, no experiment should be conducted when there is an a
priori reason to believe death could result except if experimental physicians also
2/5
1. clinical research: studies in which people participate as patients or healthy
volunteers
2. What is the purpose of clinical research?: To develop new treatments or
medications, identify causes of an illness, study trends, correlate illness to
genetics.
3. What is the correlating FDA organization in the United Kingdom?: MHRA
4. What is the correlating FDA organization in Europe?: EMA
5. What is the correlating FDA organization in Australia?: TGA
6. What is the drug development process?: synthesis and manufacture of a drug
(white powder) and testing for safety in animals (preclinical testing)
7. What is the clinical research process?: testing for safety and efficacy in
humans (clinical development), submission of data to the FDA (Govt. review),
commercial product available to the public, post-market surveillance
8. Drug discovery occurs:: in the animal laboratory by chance observation or at
the bedside by an acute clinician.
9. The function of the formal controlled clinical trials is to:: separate the relative
handful of discoveries which prove to be true advances in therapy from a legion
of false leads and unverifiable clinical impressions, and to delineate in a scientific
way the extent of and the limitations which attend the effectiveness of drugs.
10. What was the first documentation of a clinical trial?: 605 B.C. - Book of
Daniel; if a vegetarian diet for 10 days was better than King's meat and wine; those
who ate a vegetarian diet were generally healthier after 10 days.
11. What was the first modern documentation of a clinical trial?: 1747 -
James Lind's Scurvy experiment; Lind compared the addition of (1) cider, (2)
sulfuric acid, (3) vinegar, (4) seawater, (5) oranges and lemons and (6) a paste
prepared with barley water to treat scurvy. The patients taking the
orange/lemon addition showed positive results.
12. How many patients were in James Lind's scurvy study?: 12 total with two
patients in each study group
13. FDA Pure Food and Drug Act: 1906 - products could not be sold for
indications outside of the label and prohibited interstate transportation of
unlawful food and drugs; FDA was a policing agency
14. Sulfanilamide Disaster: 1937 - sulfanilamide was dissolved in diethylene
glycol to make it easier to swallow and was marketed to children; over 100
patients died
1/5
, 15. Federal Food, Drug, and Cosmetic Act: 1938 - Required proof of safety
before a new drug could be released and the drug must be labeled with directions
for safe use
16. What changed the FDA from a policing agency to a regulatory agency and
when did this occur?: The Federal Food, Drug, and Cosmetic act in 1938; the
FDA oversees the evaluation of new drugs.
17 Nuremburg Code: 1947 - result of the Nuremburg Trials that occurred during
WWII; it is a set of principles to guide human experimentation, including informed
consent, absence of coercion, sound scientific experimentation and charity to
participants
18. Syphillis Study: 1932-1972 - US Public Health Service conducted studies
on 600 syphilis-positive African Americans to evaluate the effects of syphilis; no
informed consent and some were denied access to penicillin
19. Kefauver-Harris Amendment of 1962: • Also known as the "Drug Efficacy
Amendment".
• Required drug manufacturers to provide proof of the effectiveness and safety
of their drugs before approval .
• Required drug advertising to be more closely regulated and disclose accurate
information about side effects
In response to the thalidomide tragedy
20. Declaration of Helsinki: 1964 - Developed by the World Medical Association;
focuses on the respects and rights of the subjects/patients; the rights of the patients
will not be compromised for the sake of science
21. The Belmont Report: 1979 - Developed in response to the Syphilis Study and
established basic principles for the TX of subjects/patients; respect for persons,
beneficence, and justice
22. FDA and Title 21: 1981 - Establishment of the drug development process and
GxPs; guidelines
23. International Conference on Harmonization (ICH): 1990 - Established
guidelines which unifies countries on the basis of clinical studies
24. What did the ICH do?: Made it unethical to repeat studies with different
patients and exposing them to risk for data that another country may already have
25. What are the seminal documents regarding ethics in clinical trials?:
Nuremburg Code, Declaration of Helsinki, the Belmont Report
26. What does the Nuremburg code consists of and its main points?: 10
points with voluntary consent being absolutely essential, experiment cannot be
procured by other means, no experiment should be conducted when there is an a
priori reason to believe death could result except if experimental physicians also
2/5
