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2.1 Professional Practice > Clinical Trials > Flashcards

Clinical Trials Flashcards

1
Q

Define tissue culture

A

In-vitro cultivation of organ tissues and cells in a favourable artificial growth situation

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2
Q

Give some examples of where tissue cultures would be used

A

Vaccine research
Cancer research
Protein therapeutics

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3
Q

What are the two types of tissue culture?

A

Primary cell lines
Secondary cell lines

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4
Q

What are primary cell lines?
(2)

A

Primary cells are directly prepared from an organism’s tissues

These grow and proliferate a finite number of times

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5
Q

What are secondary cell lines?

A

These are derived from clinical tumours or created from transforming primary cells with viral oncogenes or chemical treatments

These will grow indefinitely

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6
Q

What are some benefits of primary cell lines over secondary cell lines?
(3)

A

They more closely represent the tissue of origin

They are similar to the in vivo state and exhibit normal physiology

They provide excellent model systems for studying

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7
Q

How can primary cell lines provide excellent model systems for studying
(2)

A

They can be used for the normal physiology and biochemistry of cells e.g. metabolic studies, aging, signaling studies

They can be used to display the effects of drugs and toxic compounds on the cells

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8
Q

What types of cells are used in primary cell cultures?
(8)

A

Epithelial cells
Fibroblasts
Keratinocytes
Melanocytes
Endothelial cells
Muscle cells
Hematopoietic stem cells
Mesenchymal stem cells

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9
Q

Write a note on transformation
(3)

A

Cultures are initially heterogeneous and can be maintained in vitro only for a limited period of time

Transformation can occur spontaneously or can be chemically or virally induced

Transformation is the the process whereby cells divide indefinitely and become an immortalised secondary cell line

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10
Q

List the advantages of primary cells overall
(3)

A

Use of primary cells avoids many ethical objections raised against animal experiments

The use of primary cells provides more relevant results than cell lines

They are cost-effective as they help reduce the expenditure on animal models required for in vivo studies

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11
Q

What are the challenges of primary cells?
(6)

A

Take more time to grow than other cell lines

Have limited growth potential even under optimal growth conditions and eventually senesce and die

Cells from different donors behave differently in response to pro-inflammatory cytokines. The growth of metabolic regulatory mechanism that exist under in vivo conditions are absent in culture conditions

Cost of isolation and culture is often high and prohibitive through cheaper than animal models

The tissue culture may not be always possible

Characteristics of cells may change with each subsequent passage if optimum culture conditions are not maintained

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12
Q

Give some applications of primary cell lines
(8)

A

3D Cell Culture
Cancer Research
Virology
Drug Screening and Toxicity Testing
Vaccine Production
Genetic Engineering
Tissue or Organ Replacement
Stem Cell Therapy

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13
Q

Give an example of a culture collection

A

The American Type Culture Collection (ATCC) Cell Biology Collection

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14
Q

What does the ATCC contain

A

Over 3,600 cell lines from over 150 different species

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15
Q

What cells are often used in research in place of primary cells?

A

Immortal cell lines

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16
Q

Give some examples of immortal cell lines

A

3T3
HeLa
COS

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17
Q

What is 3T3

A

Mouse embryonic fibroblast

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18
Q

What is a Mouse embryonic fibroblast used for

A

Robust and easy to handle
Contact inhibited
Stops growing at very high densities

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19
Q

What is a HeLa cell

A

From cervical cancer in a human patient named Henrietta Lacks

May contaminate other culture cell lines

Able to grow in suspension

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20
Q

What are COS cells

A

Monkey Kidney cells

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21
Q

What are Monkey Kidney cells
(2)

A

Efficiently transfected

Commonly used as an expression system for high-level, short-term expression of proteins

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22
Q

List the advantages of immortal cell lines
(5)

A

Cost effective
Easy to use
Unlimited supply of material
Bypass ethical concerns associated with the use of animal and human tissue
Provide a pure population of cells

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23
Q

List the limitations of immortal cell lines
(4)

A

Genetic manipulation may alter their phenotype, native functions and their responsiveness to stimuli

Serial passage of cell lines can further cause genotypic and phenotypic variation over an extended period of time

Cell lines may not adequately represent primary cells and may provide different results

Contamination with other cell lines and mycoplasma

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24
Q

Write a note on HeLa Cells
(5)

A

Epithelial cells from the cervix of Henrietta Lacks

She died in 1951 dur to an aggressive cervical cancer

While she was being treated doctors had taken samples of her cancerous cells

Her tissue was shared with researches without her knowledge or consent

Her cells have an extraordinary capacity to survive and reproduce - immortal

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25
What contributions were made by HeLa Cells? (4)
Contributed to many medical breakthroughs Used in research on the effects of zero gravity in outer space Used in the development of polio and COVID-19 vaccines Used in the study of leukaemia, the AIDS virus and cancer worldwide
26
Define clinical studies? (2)
Research studies that evaluate new ways to improve treatments and quality of life for people with diseases It involves research using human volunteers/participants that is intended to add to medical knowledge
27
What are the two types of clinical research studies?
Clinical trials Observational studies
28
What is the aim of clinical trials?
The results help to develop New Drugs, New Procedures, New Research
29
What are the four uses of animal models
To advance scientific knowledge To study disease and develop medicines To assess the safety of chemicals Teaching
30
How are animal models used to advance scientific knowledge?
Used to learn about the ways animals and humans develop and function biologically
31
How are animal models used to study disease and develop medicines? (2)
Animals are used as models to understand disease processes and to develop new vaccines and medicines e.g. RA, polio, Hep C Genetically modified animals e.g. mice are used to study the role of genes in disease processes
32
How can animal models be used to assess the safety of chemicals?
Animals are used in toxicological studies to test the safety of substances that could be harmful to animals, humans or the environment (e.g. household/industrial chemicals, fertilisers, food additives)
33
Give four examples of animal models
Yeast Zebra fish Mouse Macaque Monkey
34
What yeast species is used in animal models
Saccharomyces cerevisiae
35
What fish species is used in animal models?
Danio rerio
36
What species of mouse is used in animal models?
Mus musculus
37
What species of monkey is used in animal models?
Macaca mulatta
38
What are the benefits of using yeast in animal trials? (3)
Single celled eukaryotes which can be grown in vitro Replicates quickly Genes are easy to manipulate
39
What are the benefits of using zebra fish in animal trials
Embryos and larvae are transparent Can use fluorescence as visual tool Useful in transgenic models
40
What are the benefits of using mice in animal trials? (3)
Genetically similar to humans Inbred colonies have limited diversity Nude strains are immunodeficient
41
What are the benefits of using macaque monkeys in clinical trials? (3)
Genetically similar to humans Similar immune responses to humans Useful for longitudinal studies
42
Write a note on Dolly the Sheep (5)
First mammal cloned from an adult somatic cell Cloned at the Roslin institute in Scotland Used the process of nuclear transfer from a cell taken from a mammary gland Her cloning proves that a cloned organism could be produced from a mature cell from a specific body part Successful cloning led to widespread advancements within stem cell research including the discovery of induced pluripotent stem cells.
43
Write a note on Macaques and HIV (3)
The only animal species susceptible to HIV viruses are non human primates Macaques infected with viruses close to HIV-2 (SIVmac) are the most commonly used Almost identical pathophysiological features of HIV-1 pathogenesis
44
What are the pros of animal models (5)
Test many hypothesis Most similar to humans No human genetic ethical dilemma Genetically modified Shortens length of study
45
What are the cons of using animal models
Creating a representative phenotype is difficult Ethical dilemma Expensive Difficult to replicate
46
What are the cons of using animal models
Creating a representative phenotype is difficult Ethical dilemma Expensive Difficult to replicate
47
What were the three aspects of the directive of 2010/63/EU of the European Parliament on the protection of animals used for scientific purposes
Replacement Reduction Refinement
48
The directive of 2010/63/EU introduced a replacement aspect for animal models, what does this mean?
This involves the acceleration of the development and use of models and tools, based on the latest science and technologies, to address important scientific questions without the use of animals i.e. avoid using animals as much as possible or bypass animal testing if possible
49
The directive of 2010/63/EU introduced a reduction aspect for animal models, what does this mean?
This refers to methods that minimise the number of animals used per project or study consistent with the scientific aims
50
The directive of 2010/63/EU introduced a refinement aspect for animal models, what does this mean?
This refers to methods that minimise the pain, suffering, distress or lasting harm that may be experienced by the animals, and which improve their welfare
51
Where are clinical studies used (6)
New drugs or new combinations o f drugs New ways of doing surgery New medical devices New ways to use existing treatments New ways to change behaviours to improve health New ways to improve the quality of life for people with acute or chronic illness
52
When was the first experiment carried out to resemble clinical trials?
500 BC
53
What happens in a clinical trial? (4)
Participants receive specific interventions according to the research plan or protocol created by the investigators e.g. changes to participant's behaviour e.g. diet, procedures e.g. surgery or medical products e.g. drugs or devices An attempt to determine the safety and efficacy of the intervention by measuring certain outcomes in the participants Clinical trials may compare new medical approaches to old ones or placebos Clinical trials may compare two interventions that are already available to each other
54
What happens in observational studies (3)
Investigators assess health outcomes in groups of participants according to a protocol or research plan Participants may receive interventions, which can include medical products, such as drugs or devices, or procedures as part of their routine medical care, but participants are not assigned to specific interventions by the investigator Cohort study
55
What are the six phases to clinical trials (6)
Preclinical + approval for clinical trials Phase 1 (20-80 participants) Phase 2 (100-300 participants) Phase 3 (1,000 to 3,000 participants) + application for regulatory approval Regulatory review process (assessment of safety and efficacy) + regulatory approval Phase 4 (1,000+ participants)
56
What happens in phase 1 trials (4)
Clinical pharmacology and toxicity To determine if the drug can safely be given to humans, and what dosage levels can be given without causing serious side effects Usually conducted on volunteers 20-80 normal volunteers
57
What happens in phase 2 trials? (6)
Initial clinical investigation for treatment effect Small number of closely-monitored patients receive the drug Safety and effectiveness evaluated Determines if the new treatment has an effect on the disease Used to see how the new treatment affects the body and fights disease Involves 100-200 patients
58
What happens in phase 3 trials (3)
Controlled evaluation of treatment Compares the new treatment to the current 'best practice' treatment(s) in a substantial number of patients Often simply called clinical trials or controlled clinical trials
59
What happens in the regulatory review process? (3)
The decision about the value of the new treatment will rest on the clinical trials Vital that these are conducted so that the possibility of bias is minimised Approved by regulatory bodies such as FDA or EAM
60
What happens in phase 4 trials?
Postmarketing surveillance Monitoring of adverse reactions and long-term consequences of use Refine prescribing indications by documenting rare complications, subgroups of patients with poor response Long term follow-up of drug reactions
61
What are four key methodological features of a clinical trial (4)
Controlled - treatment is evaluated against a defined alternative Randomised - patients allocated treatments at random ensuring comparability Blinded - to reduce bias Intention-to-treat analysis - analysis based on treatment allocation, not adjusted for compliance
62
What is a control (5)
The control group Used as a baseline for comparison Allows clear interpretation of results Control group receives the same treatment as the intervention group except for the intervention being assessed Compensates for Hawthorn effect and for unusual intensity of treatment during trials
63
What is the Hawthorn effect?
Alteration of behaviour due to being observed
64
What is randomisation (4)
Random allocation of patients to treatments No characteristic of the patient can influence the treatment they receive Ensures comparability of treatment and control groups But does not allow for patient preference -> which may be important in determining treatment sucess
65
What are the different types of blinded testing and what is the point?
It eliminates bias Single blinded (either subjects of assessors blind) Double blind (both subjects and assessor blind) Triple blind (subject, assessor and data analyst is blind)
66
What are open label trials or non-blinded trails (2)
Participants are aware which treatment they have been allocated to Used to compare treatments or gather additional information about the long-term effects in the intended patient population
67
What is intention to treat analysis (4)
All persons randomised to a treatment are counted in the analysis not just those who complete it or comply with it This means we are evaluating the treatment policy Analysing those who complete treatment is called 'per protocol' analysis Useful if treatments are long e.g. TB drugs
68
What three principles/responsible in good clinical practice
Good Clinical Practice (GCP) Principles 2.1 and 2.8 Investigator Responsibility 4.1.3
69
What are the good clinical practice principles (3)
Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s) The investigator should be aware of, and should comply with, GCP and the applicable regulatory requirements
70
What does regulation 24 of the Regulations for Clinical Trials on Medicinal Products for Human Use State
A person shall not conduct a clinical trial otherwise than in accordance with the conditions and principles of good clinical practice
71
List some ethical issues
Consent Reduced capacity Fair distribution of benefit
72
Write a note on consent (3)
Patient may receive treatment which turns out to be inferior, or may simply get a placebo They will have to forego their right to know their treatment For these reasons, informed consent is vital
73
Write a note on reduced capacity (2)
Some patients will have reduced capacity to understand the issues or to give consent Their interests require special protection
74
Write a note on fair distribution of benefit (3)
The people in the trial must stand to benefit - not necessarily as individuals but at least as a group Altruism: doing things for the good of others, is a right Doing research on captive populations or groups who are unlikely to benefit is unethical
75
Define clinically significant
The treatment must produce a worthwhile effect in terms of the patient's health - a drug that lowers cholesterol by 2% is no actual use!
76
Define statistically significant
The treatment benefit must have been so large that it is unlikely to have occurred by chance in a patient group as big as the one being studied.
77
What percentage of new therapeutic products that reach clinical testing are not approved or reach commercialisation adn why? (40
90% 52% of these are due to lack of efficacy i.e. the treatment doesn't work in the proposed dosage or formulation 24% due to safety issues i.e. adverse drug reactions 24% due to various technical or commercial reasons
78
Give three examples of clinical trials that went wrong
Thalidomide - 1960s The University of Minnesota Seroquel Experiment 2003 The Elephant Man Trial 2006
79
Write a note on the thalidomide scandal (4)
Originally intended as a sedative or tranquiliser but was soon used for treating a wide range of other conditions including colds, flu, nausea and morning sickness in pregnant women Researchers tested the drug on animals but neglected to observe the effects on their offspring Deemed safe as impossible to die from overdose William McBride discovered the link between Thalidomide and the deformities in children and mothers who took the drugs -> children born with shortened limbs or loss of limbs particularly arms
80
Write a note on the university of minnesota Seroquel experiment 2003
In 2003 Dan Markingson was diagnosed with schizophrenia and admitted to the University of Minnesota Medical Center He was put into a clinical trial testing three types of medications including Seroquel Daily 800mg of Seroquel worsened his delusions His mother attempted to remove him but the school blocked his removal as participation was worth 15,000 to the school 1/5 people on trial attempted suicude 2 people died by suicide - Dan was one of these
81
Write a note on the university of minnesota Seroquel experiment 2003 (6)
In 2003 Dan Markingson was diagnosed with schizophrenia and admitted to the University of Minnesota Medical Center He was put into a clinical trial testing three types of medications including Seroquel Daily 800mg of Seroquel worsened his delusions His mother attempted to remove him but the school blocked his removal as participation was worth 15,000 to the school 1/5 people on trial attempted suicude 2 people died by suicide - Dan was one of these
82
Write a note on the Elephant Man Trial 2006 (6)
Clinical Trial testing a new cancer treatment called TGN1412 Preclinical trials performed in Macaque monkeys whose DNA is a 94% match to humans Shortly after taking dose all patients began writhing in pain and vomiting One patient lost his fingers and toes Another had his foot partially amputated One participants head swelled up 'Elephant Man'

2.1 Professional Practice (10 decks)

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