Clinical trials

• Define a clinical trial

  A research study that uses human subjects which are given different treatments to evaluate the effects.
• What are the stages in a clinical trial

  Pre-clinical trial

  Phase I

  Phase II

  Phase III

  Phase IV
• What is the pre-clinical trial phase

  This is conducted in vitro or vivo.

  It establishes the dose, pharmacodynamics and the long term side effects.
• What is in vitro

  The use of cells
• What is in vivo

  The use of animals
• What is pharmacokinetics

  How the drug is metabolised
• What is pharmacodynamics

  The effects of the drug
• What is the first in man trial

  Phase I
• What type of volunteers are used in Phase I

  Healthy
• What is the role of Phase I

  To establish the maximum tolerable dose and the frequency of dosage.
• What is MTD

  The maximum tolerable dose
• Define a healthy volunteer

  These are people with no significant health condition and do not have the condition for the trial .
• What is the main ehtical issue with Phase I

  It uses healthy volunteers that are payed for their service.
• Give two Phase I trials that went wrong

  The autoimmune trial in 2006.

  The chronic pain trial in 2016.
• What was the outcome of the autoimmune trial of 2006

  It lead to an establishment of sequential doses.
• What was the issue in the chronic pain trial 2016

  The jump in doses was too high.
• What phase is proof of concept

  Phase II
• What patients are used in Phase II

  Those with the disease
• How many patients are used in phase I

  100 - 200
• How many patients in phase II

  200 - 500
• What is Phase II

  It examines dosage, response rates and side effects in individuals with the disease.
• What phase is the drug patente at

  Phase II
• What is phase III

  Efficacy of treatment
• Describe phase III

  It is a randomised controlled trial of the new drug against a current treatment or placebo.
• What is collected in Phase III

  the response and side effects
• What is the main ethical concern in clinical trials

  Underrepresentation of specific races throughout the different phases.

  Phase I is typically made up of ethnic minorities, and the latter phase is predominantly white people.

  Women tend to be underrepresented due to fears about fertility.
• What is phase IV

  Post license testing.
• Describe phase IV

  This monitors the safety and efficacy of the drug.

  And looks and long term use and side effects.
• What system is used in Phase IV in the UK

  The yellow card system. This allows people to report side effects.
• Give an example of post licensce promotion that was harmful

  Jonhson and Johnson promoted propulsid off-label for children even though they knew there were some safety concerns.
• What is off label use of a drug

  This is the use of a drug for something it has not been approved for.
• What are the UK laws related to medical research

  The Human Tissue Act of 2004 and the UK law of tort.
• What is the UK law of tort

  It states that the intentional and direct use of force to a person without justification is a civil matter and not criminal.

  It allows for those who have been harmed to be compensated.
• Describe the human tissue act

  It regualtes the removal, storage, use and disposal of human tissue and cells.
• What is the Nuremberg code

  It states that voluntary consent is required for a human subject.
• When was the nurembeer code

  1948
• When was the declaration of helsinki 


  1968
• Describe the decleration of helsinki

  Informed consent is required for all non-therapeutic research.

  Informed consent is only required for therapeutic research if consistent with the patients psychology.
• What is the Belmont reprot

  It is common law in the US. And details that you should respect a person's consent without deception. And also outlines the principles of justice and beneficence.
• What year was the belmont report

  1978