L10- Cinical trials 2

What is a clinical trial

A research study in which one or more human subjects are prospectively assigned to one or more interventions to evaluate the effects of those interventions on health related biomedical or behavioural outcomes

Things to consider when setting up and running a clinical trial (7)

• consent

• Controls

• Randomisation

• Blinding

• Sample size

• Statistics

• Ethics

What is one of the main focuses when setting up and running a clnical trial

Finding ways to minimise bias

What is bias

Systematic errors that encourage once outcome over others

What are hte potential effect of bias

That investigators will come to the wrong conclusions about te beneficial and harmful effects of interventions

What can bias in clinical trials result in (3)

• over- estimation of the effects of treatments

• Treatments look better than they really are

• Make ineffective treatments look as if they work

What is ethics

The moral principles that govern a persons behaviour or the conducting of an activity

What are ethical considerations in research

A set of principles that guide your research designs and practices

Examples of ethical considerations (5)

• voluntary participation

• Confidentiality

• Consent

• Anonymity

• Potential for harm

What is consent

Is the idea that human participants can enter research freely and voluntarily with full information about what it means for them to take part, and that they give consent before they either the research

Key parts of consent (5)

• participant understands what the research is an what they are consenting to

• Research must give sufficient and appropriate information about the trial

• Must ensure there is no coercion

• Time should be given for theparticipant to consider the choice and discuss if appropriate

• Participants has the right to withdraw at any time wihtout any impact on standard of care

What is a control group

The standard to which comparisons are made in an experiment→ composed of participants who do not receive the experimental treatment

What si teh ideal control group

One that is identical to the experimental group in every way except for the fact that the experimental groups are subjected to the treatment

What is randomisation

The process by which treatments are assigned ot participants by chance rather than by choice

Types of randomisation

• simple randomisation n

• Block randomisation

• Stratified randomisation

What is simple randomisation

Randomisation based on a singe sequence of random assignments

What does simple randomisation maintain

Complete randomness of the assignment of a subject to a particular group

Advantages and disadvantages of simple randomisation (2 each)

• Advantages:

  • Simple

  • Easy to implement

• Disadvantages:

  • Could result in unequal number amongst groups

What is block randomisation

Designed to randomise subjects into groups that result in equal sample sizers