Lecture 8

Question 1

1930s-1940s WWII

Answer 1

Nazi physicians conducted unethical experiments on concentration camp prisioners

Question 2

Tuskegee Syphilis Study

Answer 2

A study in Macon county, Alabama to determine the full progression of Syhilis in humans.
last 40 years.

Question 3

Henrietta Lacks (1951)

Answer 3

Had cancer, had a biopsy of cervical cancer tissue without her consent. Discovered she had immortal cells that never stopped growing and dividing (HeLa’s)
Used in 3 nobel prize winning studies, she nor her family knew about the cells until recently

Question 4

Nuremberg Code

Answer 4

Requires voluntary, informed consent for participants in research

Question 5

Helsinki Declaration

Answer 5

informed consent, responsibility to protect the patient over the science and particular assistance to vulnerable patiens

Question 6

FDA

Answer 6

accountability in marketing of food and drugs and regulations regarding testing drugs in clinical trials

Question 7

Clinical trials

Answer 7

any research project that prospectively assigns human subjects to intervention and comparison groups to study cause-and-effect relationships between a medical intervention and health outcome

Question 8

Drug Discovery & Development

Answer 8

Researchers discover new drugs through
- new insights into a disease proccess
- testing of molecular compounds
- existing treatments that have unanticipated effects
- new technology
At this stage they are asking questions

Question 9

Preclinical research

Answer 9

before testing in humans, the drug will be tested in vitro (cells in petri dish) or in vivo (animals models)

Question 10

Clinical trials

Answer 10

Prior to beginning a clinical trial, a researcher must submit an application to the FDA with the following information:
- animal study data and toxicity
- manufacturing info
- clinical protocols
- data from prior research
- info about the investigator

Question 11

Phase 1 clinical trials

Answer 11

study participants: 20-100 healthy volunteers w/ the disease/condition
length: several months
purpose: evaluate safety, dosage, and side effects
70% move to next phase

Question 12

Phase 2 clinical trial

Answer 12

study participants: several hundred people w/ disease/condition
length: several months to 2 years
purpose: test effectivness and side effect
33% go on to next phase

Question 13

Phase 3 Clinical trials

Answer 13

study participants: 300-3000 volunteers with disease/condition
length: 1 to 4 years
purpose: confirm effectiveness and monitor reactions; compare to other treatments
25-30% move to next phase

Question 14

Phase 4 clinical trials

Answer 14

study participants: several thousands with disease/condition
purpose: provide any other infor, practice best use, confirm benefits

Question 15

Drug review

Answer 15

once the drug is showing promise in the clinical trials, the researcher will apply the FDA to market the drug. Application must contain information including all data from preclinical research-all phases of clinical trials and -
Proposed labeling
safety update
drug abuse info
patent info
data from studies outside US
Directions for use

Question 16

project manager

Answer 16

coordinates the team’s activites throughout the review process and is the primary contact for the sponsor

Question 17

medical officer

Answer 17

reviews all clinical study info and data before and after the trial is complete

Question 18

statistician

Answer 18

interprets clinical trial designs and data, and works cloesly with the medical officer to evaluate protocols and safety and efficacy data

Question 19

Pharmacologist

Answer 19

reviews preclinical studies

Question 20

harmakineticist

Answer 20

focuses on the drug’s absorption, distribution, metabolism, and excretion processes. Interprets blood-level data at different time intervals from cliical trials, as a way to assess drug dosages and administration schedules

Question 21

Chemist

Answer 21

evaluates a drug’s chemical compounds. Analyzes how a drug was made and its stability quality control, continuity, the presence of impurities

Question 22

microbiologist

Answer 22

reviews the data submitted, if the product is an antimicrobial product, to assess response across different classes of microbes.

Question 23

Post-market drug safety and monitoring

Answer 23

Continuous monitoring and surveilance of a drug and its effect is important to maintain the highest level of safety possible for the population

Question 24

Emergency Use Authorizations

Answer 24

EUS authority allows FDA to Help strengthen the nation’s public health protections against chemical, biological, radiological and nuclear threats including infectious diseases, by facilitating the avalibility and use of medical countermeasures needed during public health emergencies.