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PHAL221 > Clinical trials > Flashcards

Clinical trials Flashcards

1
Q

clinical trial gone wrong

A

cannabinoid drug that caused death/brain damage
FAAH - stops natural cannabinoids being broken down
didn’t wait long enough between increasing doses
doses higher than animal tests therapeutic dose

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2
Q

preclinical development

A

tissue models, cell cultures, brain slices, animals

MOA, pharmacokinetics, toxicology, formulation, synthesis scale up

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3
Q

drug discovery

A

preclinical development, characterisation, ED50, ADME, LD50, phase 1, 2, 3, approval, phase 4

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4
Q

phase one trials

A

first in human trials - healthy volunteers (males), small sample
test safety and tolerability, pharmacokinetics, best practice
base on info from animal studies
tolerance - MTD, MABEL
ascending doses - SAD and MAD
adverse side effects

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5
Q

MTD

A

maximum tolerable dose

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6
Q

MABEL

A

minimal anticipated biological effect level

used to determine first dose in human

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7
Q

SAD

A

single ascending doses

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8
Q

MAD

A

multiple ascending doses

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9
Q

phase two trials

A

small-scale in patients with disorder of interest
efficacy and dosage, long term toxicology, safety
best practice parameters, side effect profile in patient population
placebo or comparative

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10
Q

phase three trials

A

large scale controlled clinical trials - worldwide
test efficacy
better side effect profile
comparisons

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11
Q

regulatory approval

A

submission of full data and review by agencies
MoH -> NEAC (national ethics advisory committee) -> ethics committee + medsafe
health research council -> SCOTT (standing committee on therapeutic trials)
also needed before clinical trials

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12
Q

phase four trials

A

post release surveillance
market expansion, life-cycle management, new indications, formulations, combinations, regimens
only now are women, elderly, children introduced

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13
Q

clinical trial

A

an experiment or set to establish safety, efficacy, practicality of new drug/medical proceedure

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14
Q

example of phase 1 trial with bad results

A

MK-801 NMDA receptor non comp antagonist
effective in vivo and in vitro
hallucinations and behavioural disorders in humans

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15
Q

ethic committees review…

A

qualifications of investigators, locality assessment (crash carts, comfortable, emergency number), experiment protocol (what is done by who, statistical analysis)

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16
Q

the human factor

A

don’t give doses near LD50, not too many X-rays, blood tests

is a placebo ethical?

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17
Q

design attributes

A

control groups - confounders
random allocation - avoid bias/balance extraneous factors
blind measurements - subject and experimenter
replication - controls for random fluctuations, calculate sample size

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18
Q

side effects

A 
SAE (serious adverse event = death)
minor or serious (allergic response)
larger sample = more reported
report even if unrelated
discontinue?
19
Q

participants

A

hospitals, GPs, advertising
informed consent - benefit, failure, danger, requirements, criteria
can give consent for unconscious adult
16 +

20
Q

cultural issues

A

maori consultation, tissue storage, disposal, shipping of tissues, stored tissue/genetic analysis

21
Q

end of trial

A

is it ethical to withdraw? alternative?

continued responsibility, arrange at beginning

22
Q

access to info

A

results must be published online in full

23
Q

audits

A

inspect clinic and laboratory

FDA, client-company

24
Q

declaration of helsinki

A

protect peoples health and rights
do no harm
knowledge cannot override rights

25
Q

ethics committee

A

look at advertising, information, consent, payment (baseline), dose, samples taken, population, facilities

26
Q

medsafe

A

safety vs efficacy

adverse effects vs pharmacodynamics

27
Q

first dose in human

A

life threatening acute events, haematological/biochemical toxicity, rashes, ECG changes

28
Q

cancer drug trial benefit to patient

A

has protocol, contributing to science, treatment plan, clinical contact

29
Q

decision

A

conclusion or resolution reached after consideration
choice from several possibilities
-> commitment of resources, specification of criteria

30
Q

decision points

A

lead identification, entry to development, first in human, proof of mechanism, proof of concept, phase 2/3 transition, submission, approval, risk management, pricing, post-marketing

31
Q

NCE

A

new chemical entity

32
Q

better than competitor?

A

effectiveness, safety, patient factors (easy/adherence)

33
Q

ketamine

A

anaesthetic -> treatment resistant depression and anxiety
R and S racemic mixture injections
S enantiomer only? more potent, less side effects, expensive to separate

34
Q

ketamine animal studies

A

investigate route of administration

IV = high Cmax and AUC, IM = R and S different

35
Q

ketamine human studies

A

oral + tamper resistant tablets, slow release rate = less potential for abuse
chiral vs non chiral = no difference
adverse effects = dissociation, headache, dizziness
depression scale rating MADRS = 72% response

36
Q

pharmacovigilance

A

monitoring medication safety

reduce risk and harm (can’t eliminate)

37
Q

types of adverse effects

A

A - augmented (predictable from MoA or dose)
B - bizarre (rare, individual characteristics)
C - continuing
D - delayed (exposure vs outcome)
E - end of use

38
Q

ADRs

A

3-6 % of hospital admissions, increase admission time b 7.8 days, twice as expensive as medicine costs, 12% associated with disability or death

39
Q

generic medicines

A

when innovator goes off patient
cheaper
same molecule, different manufacturing, colour, formulation

40
Q

adverse events in trials

A

temporal relation, dose, nature
exclude confounders
compare with other studies

41
Q

clinical toxicology

A

diagnosis and management of poisoning

adverse health from taking something

42
Q

case definition

A

signs and symptoms of all involved
time and location - common exposures
who is and who isn’t a case

43
Q

pombe poisoning

A

interview and review records and patients and biological specimens
nausea and vomiting and seizures and death
non targeted screening found answer LC-MS = fatty acid bongkrekic acid produced by bacterium

44
Q

investigating toxicity

A

look for further cases
list possible toxins
review literate and evaluate
confirmatory testing for source and clinical specimens

PHAL221 (5 decks)

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