Clinical Trials = What can go wrong? Flashcards

1
Q

Outline the risks of clinical trials.

A

Patients = Physical and Psychological injury - DEATH.
Investigational Medicinal Product = Efficacious treatment not progressed due to risk mitigation strategies.
Population = Trust in regulation of clinical trials alongside participation in clinical trials.
There is also trust in new medicines.

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2
Q

What is the definition of Adverse Event (AE)?

A

Any desirable event occurring to a subject during a clinical study whether or not related to the investigational product.

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3
Q

List the different categories of Adverse Event.

A

Mild Events = Easily tolerated with no disruption of normal daily activity.
Moderate Events = Sufficient discomfort to interfere with daily activity.
Severe Events = Incapacitate and prevent usual activity or require complex medication or hospitalisation.

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4
Q

What is the definition of Adverse Drug Reaction (ADR)?

A

Any unwanted or harmful reaction experienced following the administration of a drug or combination of drugs under normal conditions of use and suspected to be related to the drug.

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5
Q

List the different categories of Adverse Drug Reaction.

A

There are 6 types. Type A - F.
Type A = Related to pharmacological actions and occur within therapeutic dosage range. (DOSE DEPENDENT).
Type B = Idiosyncratic = Not related to pharmacological actions and is unpredictable.
Type C = Associated with chronic dosing (IE: Steroids)
Type D = Delayed reactions (EG: Teratogens)
Type E = Drug withdrawal.
Type F = Unexpected failure of treatment (Drug Interactions).

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6
Q

What about on target drug effects?

A

Predictable from known primary / secondary pharmacology of the drug. (Aspirin and COX).
Adverse Events represent an exaggeration of the pharmacological effect of the drug.
Dose dependence within the individual.

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7
Q

What about off target drug effects?

A

Not predictable from the primary pharmacology of the drug.

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8
Q

What is a Serious Adverse Event? (SAE).

A

Any untoward adverse even which participant suffers during the course of the study :

  • Results in death.
  • Life threatening.
  • Congenital anomaly // birth defect.
  • Medically important event.
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9
Q

What is a Serious Unexpected Serious Adverse reactions? (SUSAR).

A

A serious adverse reactions where the nature or severity of which is not consistent with the applicable product information (unexpected).

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10
Q

What is the adverse events reporting system?

A

This is a pre defined trial specific reporting system.
The investigators assign a severity to the event ( mild / moderate / severe ) and then determine relationship with investigation medicinal product for each adverse event.

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11
Q

What is the reporting protocol for a SAE or SUSAR occurring?

A
SAE = Reported to sponsor of the clinical trials within "LESS THAN 24HRS" of awareness. 
SUSAR = Reported to MHRA.
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