Discovery of Penicillin
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-Alexander Fleming (1928) a Scottish microbiologist noticed that Penicillum
notatum fungus had contaminated on of his bacteria cultures
-mold had generated a clear area around it where no bacteria was
growing
-concluded that the bacterium produced a compound (which he called
Penicillin) that specifically inhibited bacterial growth
-by the 1940's scientist still didn't have a way to produce penicillin in large
quantities
, -pharmaceutical industry was asked to step in and provide their expertise
in production
-650 billion units/month
-more beta-lactams were synthesized (mapicillin,carbenicillan,methacillan)
-mechanism not described until 1965
What is the most famous cohort study?
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The Framingham Study
-decades tracking cardiovascular outcomes
-data used for years for calculating risk scores for CV disease
-still ongoing
What is the maximum amount that should be spent to achieve an additional QALY?
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- Average estimate of ~$50000 - $60000
- The appropriate value is controversial, and other estimates are higher,
~$100K
Fast Facts about Hep C (#2)
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• Treatment:
• Last few years, many new treatments
• Sustained virologic response (SVR), a cure, achieved in >95% of patients
, - Typically 12 week regimens
- Well-tolerated
- Cost: ~$80000
Randomization
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a process of randomly assigning subjects to different treatment groups
- keeps groups as balanced as possible
-particularly for important baseline characteristics
-accomplished through stratification
Which governing body would regulate the sale of Aspirin?
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Natural and non-perscription Health Products Directorate (NNHPD)
What if is is not ethical to use a placebo?
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investigators get around this by having both groups take standard of care
(SOC)
-one group gets the intervention +SOC
-one group gets placebo + SOC
, The consent process: the 8 requirements :
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Consent must be:
1.Must be freely given by the participant or an appropriate proxy (if the
participant lacks the capacity to decide for themselves; e.g. severe
intellectual disability) (free of coercion)
2.Shall be informed (e.g. easily understandable)
3.On-going: new information and incidental findings will be shared with all
study participants, as they may wish to withdraw their consent when
provided with new information
4.Must precede data collection: Do not begin the experiment BEFORE
consent is given
5.Undue influence or coercion negate consent
6.The use of incentives must not be coercive.Excessive incentivization may
cloud a participant's judgement of whether the risks inherent in the study
are tolerable
7. Studies can include participants that lack the capacity to decide for
themselves whether to participate (e.g., young children, the intellectually
disabled, etc.) if...
a) The participant is involved in the decision making as much as possible
b) Consent from an authorized third party is attained
c) The authorized third party is NOT the researcher or a member of the
research team
d) The research is being carried out for the participant's direct benefit, or
for the benefit of other persons in the same category
8.Consent must be documented
what are the 14 things that are required in a consent form?
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Give this one a try later!
-Alexander Fleming (1928) a Scottish microbiologist noticed that Penicillum
notatum fungus had contaminated on of his bacteria cultures
-mold had generated a clear area around it where no bacteria was
growing
-concluded that the bacterium produced a compound (which he called
Penicillin) that specifically inhibited bacterial growth
-by the 1940's scientist still didn't have a way to produce penicillin in large
quantities
, -pharmaceutical industry was asked to step in and provide their expertise
in production
-650 billion units/month
-more beta-lactams were synthesized (mapicillin,carbenicillan,methacillan)
-mechanism not described until 1965
What is the most famous cohort study?
Give this one a try later!
The Framingham Study
-decades tracking cardiovascular outcomes
-data used for years for calculating risk scores for CV disease
-still ongoing
What is the maximum amount that should be spent to achieve an additional QALY?
Give this one a try later!
- Average estimate of ~$50000 - $60000
- The appropriate value is controversial, and other estimates are higher,
~$100K
Fast Facts about Hep C (#2)
Give this one a try later!
• Treatment:
• Last few years, many new treatments
• Sustained virologic response (SVR), a cure, achieved in >95% of patients
, - Typically 12 week regimens
- Well-tolerated
- Cost: ~$80000
Randomization
Give this one a try later!
a process of randomly assigning subjects to different treatment groups
- keeps groups as balanced as possible
-particularly for important baseline characteristics
-accomplished through stratification
Which governing body would regulate the sale of Aspirin?
Give this one a try later!
Natural and non-perscription Health Products Directorate (NNHPD)
What if is is not ethical to use a placebo?
Give this one a try later!
investigators get around this by having both groups take standard of care
(SOC)
-one group gets the intervention +SOC
-one group gets placebo + SOC
, The consent process: the 8 requirements :
Give this one a try later!
Consent must be:
1.Must be freely given by the participant or an appropriate proxy (if the
participant lacks the capacity to decide for themselves; e.g. severe
intellectual disability) (free of coercion)
2.Shall be informed (e.g. easily understandable)
3.On-going: new information and incidental findings will be shared with all
study participants, as they may wish to withdraw their consent when
provided with new information
4.Must precede data collection: Do not begin the experiment BEFORE
consent is given
5.Undue influence or coercion negate consent
6.The use of incentives must not be coercive.Excessive incentivization may
cloud a participant's judgement of whether the risks inherent in the study
are tolerable
7. Studies can include participants that lack the capacity to decide for
themselves whether to participate (e.g., young children, the intellectually
disabled, etc.) if...
a) The participant is involved in the decision making as much as possible
b) Consent from an authorized third party is attained
c) The authorized third party is NOT the researcher or a member of the
research team
d) The research is being carried out for the participant's direct benefit, or
for the benefit of other persons in the same category
8.Consent must be documented
what are the 14 things that are required in a consent form?
Give this one a try later!
