Participant inclusion and exclusion criteria

Question 1

State the primary reason for inclusion and exclusion criteria’s

Answer 1

To define a population so clinical trial results can be generalised

Question 2

What is the purpose of such criteria’s?

Answer 2

To reduces confounding factors
To target the most relevant populations
Safety

Question 3

Inclusion criteria

Answer 3

Characteristics that fulfil the needs of the researcher/protocol for the study.

Question 4

Exclusion criteria

Answer 4

Characteristics that disqualify prospective subjects from inclusion in the study.

Question 5

State the underrepresented populations in trials

Answer 5

Older adults
Pregnant women
Children

Question 6

What are the barriers to inclusion of children in trials?

Answer 6

Ethical and legal considerations

Research must involve no or final risk to children
Consent
present potential direct benefit to the child.

Question 7

What is the result of too much exclusion in a clinical trial

Answer 7

A tightly controlled sample =
enrolling participants is more difficult
the results may not be as applicable to real clinical practice
This could lead to limitations of the population that the drug could be used in

Question 8

What is the result of too much inclusion in a clinical trial

Answer 8

A heterogeneous sample that resembles real life =

Results are broadly generalisable = greater risk for confounding variables.

Question 9

State the characteristics of a eligibility criteria.

Answer 9

Must be pre-defined
Inclusion criteria - individual must meet ALL
exclusion criteria - individual must meet NONE