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LSM4221 > L8 Clinical trial PHASE 1-3 > Flashcards

L8 Clinical trial PHASE 1-3 Flashcards

1
Q

aim of phase 1 [2]

A
  1. safety and tolerability
  2. PKPD of drug: MTD, dose range, ADRs, route of administration
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2
Q

all subjects of phase 1 must be _____

A

VOLUNTEERS

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3
Q

criteria to select volunteers/patients for phase 1? [3]

A
  1. usually male unless disease is gender specific
  2. free of substance abuse
  3. no clinical or laboratory abnormalities
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4
Q

who conduct phase 1?

A

specialist and pharmacologists

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5
Q

is phase 1 an open or closed trial?

A

open

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6
Q

what kind of drug cannot be tried on healthy volunteers in phase 1?

A
  • Drugs that are too toxic eg anti-Cancer drugs
    • Those that affect germline cells
    • Drugs to treat rare genetic conditions
      Eg. Anti-HIV drugs
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7
Q

aim of phase 2

A

efficacy and safety IN PATIENTS

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8
Q

Is phase 2 open or closed trial?

A

closed aka controlled [have placebo]

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9
Q

whats the difference between open and closed trial?

A

open: both doctor and volunteer knows what drug you’re taking
closed: volunteer OR doctor doesnt know [single or double blind]

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10
Q

why do we sometimes need a Phase IIa?

A

it acts as a PILOT clinical trial to evaluate efficacy and safety so do on small grp of patients first

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11
Q

causes of bias in clinical trial

A
  1. bias
  2. belief
  3. choice and preferences
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12
Q

ways to eliminate biases [4]

A
  1. run-in period [to allow patient to return to ‘normal’ state, esp for the illness that come and go]
  2. randomisation
  3. blinding
  4. placebo
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13
Q

why do we need randomisation [2]

A
  1. avoid bias
  2. provide basis for statistical testing
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14
Q

why do we need a run-in period? [2]

A
  • study compliance
  • exclude those with high placebo effect
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15
Q

In phase IIb, do we compare drug with placebo or current drugs in market?

A

BOTH. placebo to see if it works. current drug is want to see if more effective/ less ADR than current drug

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16
Q

does placebo have clinical effect?

A

yes, it can have clinical effects

17
Q

what is wash out period? why is it needed?

A

when patients were on pre-trial medicine. needed to ensure effects of treatment is not carried over to the next

18
Q

do all outcome measures need to be scientifically measurable?

A

no but need to be measurable.

19
Q

what is aim of phase 3?

A

larger scale of phase 2: more countries, more subjects –> determine if there is safety and efficacy issues in people

20
Q

what are the pre-clinical trial info requirements? [6]

A
  1. general pharmacology PKPD
  2. acute toxicity LD50
  3. Chronic toxicity [done in 2 animal species]
  4. Reproductive toxicity
  5. carcinogenicity and mutagenicity
  6. chemical/pharmaceutical data
21
Q

how do we measure safety and tolerability of drug during phase I?

A

-measure and check vital functions: CNS/CVS/lungs
- blood and urine test: drug concentrations
- other parameters: weight/height/body temp etc

22
Q

phase 1 trial can be done at comfort of volunteer’s home. T/F?

A

False. should be in in-patient clinic w comprehensive medical surveillance, emergency and intensive care facilities

23
Q

what are some common medical emergencies from drugs?

A

syncope, hypotension, anaphylaxis, cardiopulmonary arrest, multiple organ failure

24
Q

types of hypersensitivity [2]

A

Localised: rhinitis, asthma, rash etc
Generalised: anaphylactic shock

25
Q

dose escalation is usually ___ times of previous dose at each increment?

A

2 times

26
Q

by the end of phase 1 clinical trial, we should have results about: [2]

A
  1. safe dosage range
  2. optimal administration route + PKPD info
27
Q

duration of phase II is long. T/F?

A

False. it is short-medium duration

28
Q

is the use of placebo ethical? explain.

A

depends on disease. some diseases eg. critical illness or dependent on drug for survival should not have placebo

29
Q

why do we need a control group for phase 2?

A

to eliminate effect of natural variability of disease

30
Q

criteria for outcome measures that will be measured

A
  1. must be applicable and measurable in all participants
  2. dont have to be always scientifically measurable, as subjective ones cannot
    3.should be capable of unbiased assessment
31
Q

give examples of subjective and objective outcomes

A

Subjective: mood, sleep, pain
Objective: mortality, clinical findngs, lab measures

32
Q

state examples of tools for measuring subjective outcomes [2]

A

Hamilton depression scale, BECK DI [mood/depression], visual analogue scales [pain]

LSM4221 (13 decks)

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