introduction

Question 1

Define a clinical trial

Answer 1

systematic investigation to evaluate the safety and efficacy of medical or behavioural interventions in humans.

Question 2

whats the purpose of clinical trials?

Answer 2

To determine of a new drug device, or treatment is safe and effective for humans .

Question 3

Explain what James Lind did in the history of clinical trials?

Answer 3

1747
Included a diet of acidic food for crew on a ship with scurvy.

Crew divided into six groups, including the control group.

Question 4

Explain in further detail what a clinical trial is

Answer 4

Planned scientific study involving participant’s

prospective study comparing the effect and value of intervention against control in humans

systematic evaluations of new or modified medical devices in humans to determine their safety and effectiveness

must be scientifically sound and concisely represent the trials nature and scope

Question 5

what is are the two types of studies?

Answer 5

observational and interventional

Question 6

Whats an observational study?

Answer 6

studies that don’t involve a new intervention or treatment option.
aim to find info by observing people taking part and see what occurs in different situations.

Question 7

What is an interventional study?

Answer 7

These aim to find info about a particular intervention or treatment. Intervention trials, called clinical trials, are the gold standard for finding out if a new intervention or treatment option is suitable for people.

Question 8

What types of people are involved in clinical trials?

Answer 8

Behind the scenes
- Epidemiologists and statisticians
- lab scientists
- Clinical trial management team

Involved in the clinic
- pathologist
- NHS lab staff
- trial doctors and nurses

Regulation management and approval
- Research ethics committee
- trial sponsor
- trial funders
- regulatory organisations

Question 9

What are ethics?

Answer 9

Systematic study of values so as to decide what is right and what is wrong.

Question 10

What are the 7 ethical considerations in a clinical trial?

Answer 10

Empowering the participant for the consent - stated benefits and risks

Transparent process to follow - clear protocols and processes

Humane considerations - respect, dignity, care

internationally accepted data - by respecting ethics principles

consult the guidance regularly - up to date

authentic trial objectives - scientific justification

legal representation - of the sponsor (who is running the trials)

Question 11

What is ethical balance in clinical trials?

Answer 11

Research in not only associated with social benefits but also risks

Ethical balance in trials refers to the careful consideration and management following:
- right of participant
- dignity of participant
- safety of the participant

Question 12

What is the nuremberg Code?

Answer 12

The first major international statement in medical research ethics
Published in 1974 in response to unethical human experimentation on concentration camp prisoners in WW2
This code outlined the ethical standards for medical research, emphasising the requirement for voluntary consent to participate

Question 13

What are the core principals of the Nuremberg code? (10)

Answer 13

Voluntary consent is essential

fruitful results for the good of society

prior animal experimentation

avoidance of unnecessary physical and mental suffering

no experiment if death or disability expected

degree of risk

proper preparation

qualified scientists only

freedom to withdraw

prepared to terminate the experiment at any stage

Question 14

What are the declaration of Helsinki guidelines?

Answer 14

Issued by the world medical association in 1964 and periodically amended, the declaration of Helsinki is a comprehensive statement of the ethics of human subject research

Question 15

how many guidelines does the current Helsinki declaration contain?

Answer 15

37 guidelines

Question 16

What is the Belmont report guideline?

Answer 16

Created by the united states federal commission in 1979, this report outlines ethical principles for clinical research. The report is structured around three basic principles: respect for persons (people must be autonomous, children and vulnerable shouldn’t be influenced), beneficence(researches must not do any harm maximise benefit while minimising harm) and justice.

Question 17

What is the HIPPA guideline for ethics?

Answer 17

Health insurance portability and accountability act (HIPPA) is a US federal law enacted in 1996

To improve the healthcare system

Designed to modernise the flow of healthcare info, stipulate how personally identifiable info (PII) maintained by the healthcare and healthcare insurance industries should be protected from fraud and theft, and address the limitations on healthcare insurance coverage.

Question 18

Give examples of unethical behaviour in research.

Answer 18

• Plutonium trials
• Will brook hepatitis experiments

Question 19

What occurred in the plutonium trials?

Answer 19

The plutonium trials or plutonium injections refers to a series of experiments conducted in the US between 1945 and 1947

eighteen patients were injected with plutonium to study its metabolism in the human body.

These trials are one of the more infamous instances of unethical experimentaltion.

Question 20

What occurred in the Will brook hepatitis experiments?

Answer 20

A series of medical studies conducted at willbrook state school Staten island new York in the 1950s and 60s.

institute for children with intellectual disabilities.

experiments were designed to study natural progression of hepatitis and develop a vaccine.

Question 21

Explain the principles of informed consent

Answer 21

Participants should consent to participate in the study

participants should be fully informed about the objectives of the study

participants should be aware if the procedures followed

participants should be aware of the potential risks and benefits

participants have the right to withdraw at any point

usually a form

Question 22

Describe the earliest recorded informed consent form created.

Answer 22

May 1900

evidence of informed consent form was a contract

major Walter reed asked his volunteers in Spain to sign for his experiment on causation of yellow fever infection

Question 23

Name 4 regulatory bodies and describe what they do?

Answer 23

international council for harmonisation (ICH)
drug regulation

food and drug administration (FDA)
food and drug regulation
medical devices

EU clinical trials register
info on clinical trials conducted in EU

Medicine and healthcare products regulatory agency (MHRA)
UK drugs and medical devices
make sure quality, safety and efficacy are of a acceptable standard.