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PY367 Licensing a new drug > Stages I, II, III, and IV of clinical trials > Flashcards

Stages I, II, III, and IV of clinical trials Flashcards

1
Q

what does a clinical trial involve

A
  1. administration of new substances with therapeutic potential to people under controlled conditions for the purpose of determining
    - efficacy
    - bioavailability
    - safety
    - tolerability
    - acceptability
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2
Q

what are the requirements of the medicines for human use regulations 2004

A
  1. good clinical practice
  2. good manufacturing practice
  3. regulatory inspection and enforcement
  4. protection of incapacitated adults
  5. protection of minors
  6. pharmacovigilance arrangements
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3
Q

what are the ICH guidelines for good clinical practice

A
  1. risks and potential benefits must be assessed before trials are started
  2. interests of individual study subject must take precedence over those of science or society
  3. all trial subjects must give consent
  4. trials must be scientifically sound
  5. trials must have a clear protocol
  6. trials must be approved by a properly constituted ethics committee
  7. only properly qualified staff may be involved
  8. should be adequate preclinical testing of product
  9. product should be of adequate quality
  10. trial subjects privacy and confidentiality must be assured
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4
Q

what are the 4 phases of clinical development

A
  1. phase 1- first administration and safety evaluation in man
    - usually healthy volunteers
  2. phase 2- early exploratory and dose finding studies in patients
  3. phase 3- large scale studies in patients
  4. phase 4- post marketing safety monitoring
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5
Q

what is the aim of phase 1 trials

A
  1. preliminary info in humans
  2. exploratory
  3. safety
  4. tolerability
  5. bioavailability
  6. pharmacokinetics
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6
Q

what is the design in phase I trials

A
  1. in healthy volunteers- defined in inclusion and exclusion criteria
  2. represent the variation of the population as a whole
  3. placebo controlled
  4. randomised
  5. double blind
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7
Q

describe the data collected in phase I trials

A
  1. adverse events
  2. pharmacokinetic parameters
  3. pharmacodynamics- preliminary evidence of efficacy
  4. proof of concept
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8
Q

what are some complications to consider in phase I trials

A
  1. most phase I volunteers are men
    - women of reproductive age
  2. genetic polymorphisms
    - fast or slow metabolism
    - accumulation of drug in slow metabolisers
    - consider target population
    - where is the drug to be marketed
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9
Q

describe phase Ia Single dose trials

A
  1. 4-8 cohorts of 6-8 participants
  2. escalating dose from one cohort to the next
  3. maximum tolerated dose determined
    - before safety/tolerability issues arise
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10
Q

what do phase Ia single dose trials establish

A
  1. maximum tolerated dose
  2. pharmacokinetic parameters
    - cmax, tmax, AUC, T1/2, Vd, Mean residence time
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11
Q

what is involved in phase Ib repeated dose trials

A
  1. similar participants to phase Ia
  2. escalating repeat dose
  3. establishes steady state dosing requirements
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12
Q

what are the aims of phase IIa trials

A
  1. exploratory
  2. preliminary safety and efficacy to support a go/no go decision
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13
Q

describe the design in phase IIa trials

A
  1. in patients
  2. dose and regimen based on phase I data
  3. placebo controlled
  4. randomised
  5. double blind
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14
Q

describe the data collected in phase IIa trials

A
  1. adverse events
  2. pharmacokinetic parameters
  3. pharmacodynamics- preliminary evidence of efficacy
  4. proof of concept
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15
Q

what are the aims in phase IIb trials

A
  1. confirmatory
  2. dose selection to support registration
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16
Q

describe the design in phase IIb trials

A
  1. patients in one or more indications
  2. selected dose levels
  3. placebo or standardised treatment
  4. randomised
  5. double blind
17
Q

Describe the data collected in phase IIb trials

A
  1. adverse events
  2. pharmacokinetic parameters
  3. pharmacodynamics- preliminary evidence of efficacy
  4. proof of concept
18
Q

what are the aims of phase III trials

A
  1. confirmatory
  2. provides efficacy and safety data to support registration
  3. may include pharmacoeconomics
19
Q

describe the design in phase III trials

A
  1. patients in target indications
    - including different groups
  2. selected dose levels compared with placebo or standard treatments
  3. randomised
  4. double blind
20
Q

describe the data collected in phase III trials

A
  1. statistically rigorous measurements demonstrating safety and efficacy
  2. in comparison with standard treatments
  3. may include pharmacoeconomics
21
Q

give examples of reasons why a trial may fail

A
  1. insufficient biological activity
  2. unacceptable toxicity
  3. problems in design of trial
    - measurement criteria
    - patient selection
    - sample size
    - duration
  4. problems in execution of trials
    - randomisation of patients
    - analysis of data
22
Q

what are the aims in phase IV trials

A
  1. post marketing surviellence
  2. to reveal unexpected adverse effects/toxicity
23
Q

describe the deign in phase iV trials

A
  1. treated patients
  2. cohort studies
24
Q

describe the data collected in phase IV trials

A

adverse events

25
Q

what is the yellow card scheme

A
  1. reports made by patients and healthcare professionals
  2. assessed at MHRA
  3. if a new side effect is identified, info about how the side effect profile compares with other medicines used to treat same condition is considered
  4. MHRA takes action to ensure that medicines are used in a way that minimises risk, while maximising patient benefit
26
Q

where is the black triangle symbol indicated in

A
  1. BNF
  2. monthly index of medical specialties (MIMS)
  3. association of the British Pharmaceutical industry medicines compendium
  4. on advertising material
  5. in drug safety update
27
Q

how are black triangle drugs and products monitored

A
  1. monitored for 2 years after marketing
  2. healthcare professionals are asked to report all suspected adverse drug reaction to these products through yellow card scheme
28
Q

what are black triangle drugs

A
  1. where there is relatively limited info about safety of new drugs from clinical trials in UK
  2. trials generally involve only small umbers of eligible patients who take medicine for short period of time
  3. patients in clinical trials may not be fully representative of those who will use medicine when marketed
29
Q

what are black triangle products

A
  1. contain new combination of active substances
  2. new route of administration or drug delivery system
  3. significant new indication which may alter the established risk/benefit profile of that drug
  4. established medicine which is to be used in a new patient population
30
Q

how are problems with drugs revealed

A
  1. info supplied by manufacturers, including phase IV clinical trials
  2. side effects revealed through yellow card scheme
  3. alerts on newly marketed drugs through black triangle scheme
  4. quality checks on products carried out by MHRA inspectors
  5. tip offs about criminal activity, such as sale of counterfeit medicines
31
Q

what is MHRAs defective medicines report centre

A
  1. issues alerts to healthcare professionals, hospitals, gp surgeries, wholesalers
  2. tells them when a medicine is being called or when there are concerns about the quality that will affect its safety and effectiveness
32
Q

what are the classes of recall actions taken by regulators

A
  1. class 1- life threatening, immediate recall required
  2. class 2- harmful: recall required within 48 hours
    1. class 3- unlikely to harm patients, action required within 5 days
  4. class 4- no threat to patient safety, caution advised

PY367 Licensing a new drug (9 decks)

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