Introduction to Clinical Trials Design Flashcards
What are the key regulations for good clinical practice?
- Good Clinical Practice
- The Medicines for Human Use (Clinical Trials) Regulations, 2004
- Human Tissue Act, 2004
What is the good clinical practice regulation?
Set of internationally recognised ethical + scientific quality requirements which have to be observed for designing / conducting / reporting clinical trials.
What is the purpose of the UK medicines for human usage regulation?
Purpose:
- Protect participants from rights / safety / welfare.
- Quality assurance of data.
- Harmonise and simplify administrative procedures.
Who gives the authorisation to conduct a clinical trial?
- Ethics Committee
- Licensing Authority (MHRA)
What is the Human Tissue Act 2004?
Regulates the removal / storage / usage of human tissue.
What is illegal regarding human tissue?
The intent to have its DNA analysed but WITHOUT the consent of the person from whom the tissue came.
What is the overview of a non CTIMP study setup?
- 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.
What are the 2 types of research that is carried out?
- Quantitative Research
- Qualitative Research
What occurs in quantitative research?
- 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.
What occurs in qualitative research?
- Describes qualities / characteristics.
- Collected using questionnaires / interviews / observation / narrative form.
What are the 3 main types of hypothesises?
Null Hypothesis
Directional Hypothesis
Non - Directional Hypothesis
What is a null hypothesis?
Predicts NO difference or no relationship.
What is a directional hypothesis?
Predicts direction of difference or relationship.
What is a non - directional hypothesis?
Predicts only difference or relationship but NO direction.
What are the 3 type of quantitative research questions?
- Descriptive
- Comparison
- Causal
What is asked in a descriptive style question?
How much / What is it? ETC
What is asked in a comparison style question?
What is the difference?
What is asked in a causal style question?
A variable causes >1 outcome.
What are the 2 basic designs of a clinical trial?
Parallel Group
Crossover
What is involved in a parallel group design?
Independent Groups receiving different treatment.
What is involved in a crossover design?
Participants receive the same treatments in different order or sequence.
may involve a washout period in-between
What is the definition of a protocol in a clinical study?
A comprehensive set of instructions to carry out a scientific experiment.
What are the basic elements involved in a protocol?
- Scientific Background and Rationale.
- Objectives.
- Design.
- Data Collection and Analysis.
- Organisation of the trial.
What are the methodologies used in qualitative research?
Interviews : unstructured / semi - structured. Focus Groups. Observations. Questionnaires. Personal Log and Diaries.
What is a contextual qualitative research question?
Describe the form that exists.
What is an explanatory qualitative research question?
Examines the reasons for or associations between what exists.
What is an evaluative research question?
Appraises the effectiveness of what exists.
What is a generative research question?
Provides new ideas / questions.
What is an ideological research question?
Advance an ideology.
What is an exploratory research question?
Investigate a poorly understood phenomenon.
What is an explanatory research question?
Explain a new phenomenon.
What is a descriptive research question?
Describe a new phenomenon.
What is an emancipatory research question?
Engages in social action related to a phenomenon.
