U.12 EXPERIMENTING WITH HUMANS: CLINICAL TRIALS

Question 1

What is the common problem of the experimentation with humasn?

Answer 1

Tension between therapeutic experiments and clinical experiments

Question 2

The objective of clinical trials is to…

Answer 2

detect differences between compared drug/therapeutic strategies and eliminate non-real differences.

Question 3

To acomplish the objetive of clinical trials you have to control:

Answer 3

1. Sample size
2. Sample selection
3. Masking

Question 4

The variables involve in clinical trials can be…

Answer 4

quantitative or qualitative

Question 5

The variability of the main variable is a…

Answer 5

larger sample, greater variability.

Question 6

In the sample selection all patients should be…

Answer 6

equally likely to belong to one group or an other.

Question 7

Types of sample selection:

Answer 7

1. Simple
2. By blocks
3. Stratified (by categories)

Question 8

Masking is ….

Answer 8

concealing the treatment to avoid influence its evaluation.

Question 9

A placebo is….

Answer 9

a product with no therapeutic effect yo compare it with another therapeutically active product.

Question 10

The placebo effect is the …

Answer 10

improvement, of a patient symtons that has been taking the placebo.

Question 11

Types of masking?

Answer 11

1. Open (unmasked)
2. Single blind (patient)
3. Double blind (patient+researcher)
4. Triple blind (patient+researcher+analyst)
5. Blind for thrid parties (analyst)

Question 12

Types of clinical trials according to its design?

Answer 12

• Not controlled
• Controlled

Question 13

A not controlled clinical trial is the one with…

Answer 13

no comparison or historical comparison.

Question 14

A controlled clinical trial is the one with…

Answer 14

comparison between groups

Question 15

Types of controlled clinical trials?

Answer 15

1. Parallel design
2. Crossed design
3. Factorial design

Question 16

Tyoes of clinical trials depending on the phase of the study?

Answer 16

• Phase I
• Phase II
• Phase III
• Phase IV

Question 17

The phase I is the study on…

Answer 17

humans

Question 18

The objective of the phase I is to prove the…

Answer 18

safety and tolerability

Question 19

In the phase I the doses are…

Answer 19

very low and the increase

Question 20

The phase I is done in….

Answer 20

healthy volunteers

Question 21

What is the size of the sample of the phase I?

Answer 21

Small

Question 22

The phase II is the study on…

Answer 22

efficacy, dose, form of treatment, risks….

Question 23

What is the size of the sample of the phase II?

Answer 23

Sample of 100 to 400, vert homogeneous

Question 24

The phase III investigate the….

Answer 24

active principle for the specific disease.

Question 25

The phase III is very...

Answer 25

rigorous

Question 26

What is the size of the sample of the phase III?

Answer 26

Large

Question 27

The phase IV is done after...

Answer 27

commercialisation

Question 28

The objective of the phase IV is to see...

Answer 28

new indicators, effectiveness, efficancy....

Question 29

What is the size of the sample of the phase IV?

Answer 29

Large

Question 30

What are the 2 types of studies base on ots objective?

Answer 30

1. Explanatory studies 2. Pragmatic studies

Question 31

What is the goal of explanatory studies?

Answer 31

Knowledge concerning a treatment

Question 32

What is the goal of pragmatic studies?

Answer 32

Decide on clinical use

Question 33

What are the phases use on explanatory studies?

Answer 33

Phase I, II and early III

Question 34

What are the phases use on pragmatic studies?

Answer 34

Phase late III, IV

Question 35

What is the inclusion criteria for explanatory studies?

Answer 35

Restrictive

Question 36

What is the inclusion criteria for pragmatic studies?

Answer 36

Less restrictive

Question 37

What is the patients type on explanatory studies?

Answer 37

Homogeneus sample

Question 38

What is the patients type on pragmatic studies?

Answer 38

Heterogenous sample

Question 39

What is the sample size of the explanatory estudies?

Answer 39

Small

Question 40

What is the sample size of the pragmatic estudies?

Answer 40

large

Question 41

Objetive of the explanatory studies?

Answer 41

Pharmacokinetics, pharmacodynamics, dose-response, efficancy

Question 42

Objetive of the pragmatic studies?

Answer 42

Effectivity, tolerability, safety, efficancy

Question 43

What is the main variable of a explanatory study?

Answer 43

Biological relevance

Question 44

What is the main variable of a pragmatic study?

Answer 44

Clinical relevance

Question 45

What is the statistical analysis of a explanatory study?

Answer 45

Protocol

Question 46

What is the statistical analysis of a pragmatic study?

Answer 46

Treatment intention

Question 47

What is the ethical evaluation of a clinical trial?

Answer 47

Principle of non-maleficient, principle of justice and principle of autonomy

Question 48

CLINICAL TRIALS 1. Number of patients 2. Duration 3. Type of patients 4. Indications 5. Associated pathologies 6. Interactions 7. Dose 8. Therapeutic compliance

Answer 48

1. Small 2. Short 3. Adults 4. Restricted 5. No 6. Limited 7. Standarised 8. Controlled

Question 49

CLINICAL PRACTICE 1. Number of patients 2. Duration 3. Type of patients 4. Indications 5. Associated pathologies 6. Interactions 7. Dose 8. Therapeutic compliance

Answer 49

1. Large 2. Long 3. Aults, children, elderly pregnant (all) 4. Less restricted 5. Yes 6. Broad 7. Variable 8. Non-controlled

Question 50

Clinical trials should be carried out under conditions of...

Answer 50

respects and fundamental rights

Question 51

No clinical trial may be initiated until sufficient scientific, pharmacological and toxicological data on...

Answer 51

animals are available

Question 52

To avoid obsolete or repetitive research, clinical trials may only be initiated to demonstrate ....

Answer 52

the efficancy and safety of the proposed therapeutic modifications.

Question 53

The subject of the trial shall give his...

Answer 53

written consent

Question 54

No clinical trial may be conducted without a favorable prior....

Answer 54

report from an Ethical Commitee for clinical research