introduction Flashcards
Define a clinical trial
systematic investigation to evaluate the safety and efficacy of medical or behavioural interventions in humans.
whats the purpose of clinical trials?
To determine of a new drug device, or treatment is safe and effective for humans .
Explain what James Lind did in the history of clinical trials?
1747
Included a diet of acidic food for crew on a ship with scurvy.
Crew divided into six groups, including the control group.
Explain in further detail what a clinical trial is
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
what is are the two types of studies?
observational and interventional
Whats an observational study?
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.
What is an interventional study?
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.
What types of people are involved in clinical trials?
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
What are ethics?
Systematic study of values so as to decide what is right and what is wrong.
What are the 7 ethical considerations in a clinical trial?
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)
What is ethical balance in clinical trials?
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
What is the nuremberg Code?
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
What are the core principals of the Nuremberg code? (10)
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
What are the declaration of Helsinki guidelines?
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
how many guidelines does the current Helsinki declaration contain?
37 guidelines
What is the Belmont report guideline?
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.
What is the HIPPA guideline for ethics?
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.
Give examples of unethical behaviour in research.
- Plutonium trials
- Will brook hepatitis experiments
What occurred in the plutonium trials?
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.
What occurred in the Will brook hepatitis experiments?
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.
Explain the principles of informed consent
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
Describe the earliest recorded informed consent form created.
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
Name 4 regulatory bodies and describe what they do?
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.
