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Drug Development > Introduction to Clinical Trials Design > Flashcards

Introduction to Clinical Trials Design Flashcards

1
Q

What are the key regulations for good clinical practice?

A
  • Good Clinical Practice
  • The Medicines for Human Use (Clinical Trials) Regulations, 2004
  • Human Tissue Act, 2004
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2
Q

What is the good clinical practice regulation?

A

Set of internationally recognised ethical + scientific quality requirements which have to be observed for designing / conducting / reporting clinical trials.

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3
Q

What is the purpose of the UK medicines for human usage regulation?

A

Purpose:

  • Protect participants from rights / safety / welfare.
  • Quality assurance of data.
  • Harmonise and simplify administrative procedures.
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4
Q

Who gives the authorisation to conduct a clinical trial?

A
  • Ethics Committee

- Licensing Authority (MHRA)

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5
Q

What is the Human Tissue Act 2004?

A

Regulates the removal / storage / usage of human tissue.

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6
Q

What is illegal regarding human tissue?

A

The intent to have its DNA analysed but WITHOUT the consent of the person from whom the tissue came.

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7
Q

What is the overview of a non CTIMP study setup?

A
  • Research Question
  • Secure Funding
  • Prepare the study paperwork
  • Sponsorship
  • Submit to the R & D office for sponsorship review
  • R & D confirms you can submit to regulatory bodies and HRA.
  • Regulatory bodies assess and approve the application.
  • Full HRA approval received.
  • R & D department confirms capacity and capability.
  • Patient Recruitment can commence.
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8
Q

What are the 2 types of research that is carried out?

A
  • Quantitative Research

- Qualitative Research

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9
Q

What occurs in quantitative research?

A
  • Quantify a problem.
  • Address the ‘how / what’ aspect of a research question.
  • Hypothesis is developed in order to be tested.
  • Generates data which can be counted or compared on a numeric scale.
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10
Q

What occurs in qualitative research?

A
  • Describes qualities / characteristics.

- Collected using questionnaires / interviews / observation / narrative form.

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11
Q

What are the 3 main types of hypothesises?

A

Null Hypothesis
Directional Hypothesis
Non - Directional Hypothesis

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12
Q

What is a null hypothesis?

A

Predicts NO difference or no relationship.

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13
Q

What is a directional hypothesis?

A

Predicts direction of difference or relationship.

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14
Q

What is a non - directional hypothesis?

A

Predicts only difference or relationship but NO direction.

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15
Q

What are the 3 type of quantitative research questions?

A
  • Descriptive
  • Comparison
  • Causal
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16
Q

What is asked in a descriptive style question?

A

How much / What is it? ETC

17
Q

What is asked in a comparison style question?

A

What is the difference?

18
Q

What is asked in a causal style question?

A

A variable causes >1 outcome.

19
Q

What are the 2 basic designs of a clinical trial?

A

Parallel Group

Crossover

20
Q

What is involved in a parallel group design?

A

Independent Groups receiving different treatment.

21
Q

What is involved in a crossover design?

A

Participants receive the same treatments in different order or sequence.
may involve a washout period in-between

22
Q

What is the definition of a protocol in a clinical study?

A

A comprehensive set of instructions to carry out a scientific experiment.

23
Q

What are the basic elements involved in a protocol?

A
  • Scientific Background and Rationale.
  • Objectives.
  • Design.
  • Data Collection and Analysis.
  • Organisation of the trial.
24
Q

What are the methodologies used in qualitative research?

A 
Interviews : unstructured / semi - structured. 
Focus Groups. 
Observations. 
Questionnaires. 
Personal Log and Diaries.
25
Q

What is a contextual qualitative research question?

A

Describe the form that exists.

26
Q

What is an explanatory qualitative research question?

A

Examines the reasons for or associations between what exists.

27
Q

What is an evaluative research question?

A

Appraises the effectiveness of what exists.

28
Q

What is a generative research question?

A

Provides new ideas / questions.

29
Q

What is an ideological research question?

A

Advance an ideology.

30
Q

What is an exploratory research question?

A

Investigate a poorly understood phenomenon.

31
Q

What is an explanatory research question?

A

Explain a new phenomenon.

32
Q

What is a descriptive research question?

A

Describe a new phenomenon.

33
Q

What is an emancipatory research question?

A

Engages in social action related to a phenomenon.

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