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DOCUMENTACIÓN Y METODOLOGÍA CIENTIFICA > U.12 EXPERIMENTING WITH HUMANS: CLINICAL TRIALS > Flashcards

U.12 EXPERIMENTING WITH HUMANS: CLINICAL TRIALS Flashcards

1
Q

What is the common problem of the experimentation with humasn?

A

Tension between therapeutic experiments and clinical experiments

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2
Q

The objective of clinical trials is to…

A

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

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3
Q

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

A
  1. Sample size
  2. Sample selection
  3. Masking
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4
Q

The variables involve in clinical trials can be…

A

quantitative or qualitative

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5
Q

The variability of the main variable is a…

A

larger sample, greater variability.

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6
Q

In the sample selection all patients should be…

A

equally likely to belong to one group or an other.

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7
Q

Types of sample selection:

A
  1. Simple
  2. By blocks
  3. Stratified (by categories)
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8
Q

Masking is ….

A

concealing the treatment to avoid influence its evaluation.

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9
Q

A placebo is….

A

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

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10
Q

The placebo effect is the …

A

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

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11
Q

Types of masking?

A
  1. Open (unmasked)
  2. Single blind (patient)
  3. Double blind (patient+researcher)
  4. Triple blind (patient+researcher+analyst)
  5. Blind for thrid parties (analyst)
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12
Q

Types of clinical trials according to its design?

A
  • Not controlled
  • Controlled
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13
Q

A not controlled clinical trial is the one with…

A

no comparison or historical comparison.

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14
Q

A controlled clinical trial is the one with…

A

comparison between groups

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15
Q

Types of controlled clinical trials?

A
  1. Parallel design
  2. Crossed design
  3. Factorial design
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16
Q

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

A
  • Phase I
  • Phase II
  • Phase III
  • Phase IV
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17
Q

The phase I is the study on…

A

humans

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18
Q

The objective of the phase I is to prove the…

A

safety and tolerability

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19
Q

In the phase I the doses are…

A

very low and the increase

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20
Q

The phase I is done in….

A

healthy volunteers

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21
Q

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

A

Small

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22
Q

The phase II is the study on…

A

efficacy, dose, form of treatment, risks….

23
Q

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

A

Sample of 100 to 400, vert homogeneous

24
Q

The phase III investigate the….

A

active principle for the specific disease.

25
Q

The phase III is very…

26
Q

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

27
Q

The phase IV is done after…

A

commercialisation

28
Q

The objective of the phase IV is to see…

A

new indicators, effectiveness, efficancy….

29
Q

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

30
Q

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

A
  1. Explanatory studies
  2. Pragmatic studies
31
Q

What is the goal of explanatory studies?

A

Knowledge concerning a treatment

32
Q

What is the goal of pragmatic studies?

A

Decide on clinical use

33
Q

What are the phases use on explanatory studies?

A

Phase I, II and early III

34
Q

What are the phases use on pragmatic studies?

A

Phase late III, IV

35
Q

What is the inclusion criteria for explanatory studies?

A

Restrictive

36
Q

What is the inclusion criteria for pragmatic studies?

A

Less restrictive

37
Q

What is the patients type on explanatory studies?

A

Homogeneus sample

38
Q

What is the patients type on pragmatic studies?

A

Heterogenous sample

39
Q

What is the sample size of the explanatory estudies?

40
Q

What is the sample size of the pragmatic estudies?

41
Q

Objetive of the explanatory studies?

A

Pharmacokinetics, pharmacodynamics, dose-response, efficancy

42
Q

Objetive of the pragmatic studies?

A

Effectivity, tolerability, safety, efficancy

43
Q

What is the main variable of a explanatory study?

A

Biological relevance

44
Q

What is the main variable of a pragmatic study?

A

Clinical relevance

45
Q

What is the statistical analysis of a explanatory study?

46
Q

What is the statistical analysis of a pragmatic study?

A

Treatment intention

47
Q

What is the ethical evaluation of a clinical trial?

A

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

48
Q

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

A
  1. Small
  2. Short
  3. Adults
  4. Restricted
  5. No
  6. Limited
  7. Standarised
  8. Controlled
49
Q

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

A
  1. Large
  2. Long
  3. Aults, children, elderly pregnant (all)
  4. Less restricted
  5. Yes
  6. Broad
  7. Variable
  8. Non-controlled
50
Q

Clinical trials should be carried out under conditions of…

A

respects and fundamental rights

51
Q

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

A

animals are available

52
Q

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

A

the efficancy and safety of the proposed therapeutic modifications.

53
Q

The subject of the trial shall give his…

A

written consent

54
Q

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

A

report from an Ethical Commitee for clinical research

DOCUMENTACIÓN Y METODOLOGÍA CIENTIFICA (14 decks)

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