exam clinical trail information Flashcards

1
Q

clinical trials are

A

research studies involving people that try to answer a scientific question, to find ways to prevent, diagnose or treat disease.

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2
Q

why clinical trials

A

Effectiveness of treatment, safety of a new drug or device, defining dose administration, testing drug formulation, exploring combination therapies, evaluating effect of therapies on quality of life

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3
Q

Types of clinical trials

A

Treatment
Prevention
Screening
Supportive and palliative care

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4
Q

treatment trails participants

A

Use people already with cancer and new treatments

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5
Q

why treatment trials

A

ew treatments
Drugs, vaccines, approaches to surgery or rt, combinations of treatments, many newer treatment trials require people to have their tumours tested for generic changes first to see if treatment targeting specific changes might work better for them than standard treatment

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6
Q

treatment trails want to find out

A

Safe dose, how should the treatment be given, does it help people live longer, side effects,

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7
Q

participants in prevention trials

A

Cancer prevention trials involve healthy people. They will either be people with a high risk of developing cancer or have had cancer in the past and have a high chance of developing a new one

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8
Q

prevention trials are to

A

Looking at cancer risk and ways to reduce the risk

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9
Q

Researchers want to know in prevention trials

A

How safe it is for a person to take this agent or do this activity
Does the new approach prevent cancer

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10
Q

Two types of prevention trails

A

Actions studies - focus on finding out wether actions people take can prevent cancer, ie exercise, fruits and vegetables
Agent studies - focus on fiding out wether taking medicines, vitamines, minerals or dietary supplements may lower the risk of a certain type of cancer

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11
Q

Goal of screening trials

A

Test new ways to find disease early, when its easier to be treated

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12
Q

For screening trials they want to know

A

Does finding disease earlier, before people have any symptoms, save lives
Is one screening better than another
Do the large number of people who receive screening tests undergo unnecessary follow up tests and procedures

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13
Q

why do they need effective screening tests

A

Reduce the number of deaths due to the cancer screening

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14
Q

Quality of life/supportive care/palliative care trials look at

A

These trials look at ways to improve the quality of life of cancer patients, especially those who have side effects from cancer and its treatments

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15
Q

quality of life/supportive care/palliative care wants to find

A
New ways to help people cope with 
Pain
Nutrition problems 
Infection 
Nausea and vomiting
Sleep disorders
Depression 
Other health problems
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16
Q

quality of life trials test

A

Drugs
Activities - support groups, exercising, talking to people
Help families and caregivers cope with own needs and for the person with cancer

basically by They want to know how cancer and treatments affect patients and love ones
How they can improve their quality of life

17
Q

In vitro

A

Studies carried out in a laboratory environment

Test tubes, petri dishes ect

18
Q

In vivo

A

Effect various biological entities tested on whole, living organisms usually animals plants

19
Q

Phase 1 trials

A

Find a safe dose
Decide how the treatment is administered
How the treatment affects the human body and fights cancer
Number of cancer patient 15-30
Usually when there are no other treatment options for the patient

20
Q

Phase 2

A

Determine if it has an effect on the cancer
See how it affects the body and fights cancer
Less than 100 cancer patients take part
Can be randomised
Usually when patients have been treated with chemo,surgery, rt but these treatments have not been successful

21
Q

Phase3

A

Compare new treatment with current standard
Is the new treatment better than standard
100 - 700 thousand patients take part
Participants have equal chance to be assigned to one of two or more groups

22
Q

Phase 4

A

Used to evaluate long term safety and effectiveness of treatment
Less common phase

23
Q

Patient protection

A
Patients rights protected by 
Informed consent 
Purpose 
Procedures 
Potential risk and benefits 
Code of rights 
Scientific review 
Review boards
Ethics committee 
Data safety and monitoring boards 
Regularly review data from ongoing trials 
Ensure risk is minimised 
Ensure data integrity and validity 
Sop a trial if safety concerns