Drug Lit Midterm
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What is the literature pyramid of hierarchy?
- the best: Tertiary, Textbooks
- middle: Secondary, Medline
- bottom: Primary, Journals
What is the problem with journal supplements?
- The studies are of inferior quality and usually sponsored by one company.
- less rigorous peer review
- big pharma underwritten studies
______ responders had some form of intrxn with industry. (i.e. paid by industry)
87% of Clinical Practice Guideline
What are the gold standard resources?
- Tertiary literature:
- Facts and Comparisons
- AHFS Drug Information
- Mosby's Drug Consult
? Info can be found in these Specialty books?
Bennet's Drug Prescribing in Renal Failure
- Foreign Drugs
- Pregnancy and Lactation
- Herbal Medicine
- IV Admixture
- Renal Dosing
What is Scirus?
search engine for scientific websites only
What year was randomization first used?
What year was a control group first used?
What is chance as related to research?
What is bias as its related to research?
Placebo effect what percent of results?
What is the Hawthorne effect?
the alteration of behavior by the subjects of a study due to their awareness of being observed
Willowbrook 1950s ?
Staten Island, NY skl for mentally retarded children.. they were infected with hepatitis and observed to study the spread of the disease
Operation Whitecoat 1960?
7th day Adventist didn't want to fight in war so they were sprayed with biological warfare chemicals and observed
La Operacion 1930-1970s ?
sterilized women in Puerto Rico
Puerto Rico Pill trials 1956?
Puerto Rico women were test subjects for birth control
Milgram Obedience to Authority 1961?
electric shock experiment - people told to shock participants they couldn't see, but could here them yelling to stop.
Jewish chronic disease study 1963?
injected with live cancer cells
Tearoom Study 1965-1968 ?
observation of gay men in public restrooms, followed them home and told their partners
40yrs black pts not treated for syphilis even though a vaccine existed
Johns Hopkins Lead Paint 2001?
lead paint toxic to children..some children treated with placebo and some give investigational drug
South Korea human cloning 2004 ?
Significance of Declaration of Helsinki 1964 - 2008?
- no placebo studies if a drug already exist
- developed by World Medical Association
- provides basic principles for medical research
Significance of Nuremberg Code 1947?
- informed consent
- 12 directives for human experimentation
- in response to Nazi actions
Significance of Belmont Report 1978 ?
- respect for persons, beneficence, justice
- in response to Tuskegee
All Federally Funded research has to follow ____?
The common rule 45 CFR 46
Common Rule details?
- applies to all research involving humans
- protection for vulnerable populations
- Need IRB
- informed consent
- no coercion
IRB - abbreviated IRB details?
- at least 5 members
- 1 not affiliated w/intitution
- 1 non medical member
- both sexes represented
What are the 7 study requirements for the IRB - 46.111?
- minimize risk
- risk reasonable in relation to benefits
- equitable selection of subjects
- obtain informed consent
- document informed consent
- safety monitoring
- protection of privacy
What are the required elements of informed consent?
- statement of research
- statement of voluntariness
- descriptions of risk and benefits
- alternative treatment options
- contact information
List the advantages and disadvantages of a retrospective data?
- Advantages: data already exist, inexpensive
- disadvantages: lowest quality b/c you didn't control it, more bias
List the advantage and disadvantage of a prospective study
- Advantage: you control the study
- disadvantage: bias but less than retrospective
List the advantage of a cross-sectional study.
- advantage: quick snapshot of a certain time
- disadvantage: smaller sample
What would you like to do?
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