Lecture 1 Flashcards
Define
1) Basic research
2) Applied research
3) Descriptive
4)
Basic research
Generalized knowledge
Applied research
Practical orientation rather than the explanation focus that is inherent in basic research
Descriptive
Population characteristics (e.g., disease prevalence)
Analytical
Relationship between two or more variables
Define ECHO
Economical: direct and indirect costs
Clinical: morbidity / mortality or safety / efficacy
Humanistic: quality-of-life
What should you focus on when setting up trials?
Morbidity/ mortality and QOL
Define and describe PICOTS
1) Population: kids, adult, elderly
2) Intervention: medication, device, service
3) Comparator: placebo, Tx, usual care
4) Outcomes: economic, clinical, humanistic
5) Timing
6) Setting
1) Define descriptive measures
2) Define inferential statistics
1) Summarize sample characteristics
Mean, median, mode
2) Make inference or draw conclusion based on data
-t-test or Analysis of variance (ANOVA)
Describe the presentation of findings
1) Research report / journal article
2) Abstract
Succinct review of findings
3) Papers typically follow the same format
Introduction
Methods
Results
Discussion
Study rationale and __________ are usually found in the introduction of a paper
objective
It is not uncommon for a drug to be approved for marketing after having been studied in fewer than ___________ subjects
5,000
Only Phase _______required to get approved. Phase _______ are post-marketing studies to further evaluate safety based on a large study population.
1-3; 4
True or false: It’s fine if phase 1 trials are unblinded
True
Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 did what
-Allow pts to try a drug, but drug must have cleared phase I development
-Manufacturers are not compelled to make drugs available via this mechanism
The declaration of Helsinki did what?
World Medical Association (1964)
Recommends IRBs, consent, “do no harm,” other ethical concepts …
What is the Nuremberg code?
Response to Nazi Germany research
Participation in research must be voluntary and should never cause deliberate harm
National Research Act in 1974: What is it/ what did it do?
Response to Tuskegee Syphilis Study
Institutions wishing to engage in federally funded research must set up an Institutional Review Board (IRB)
What group was formed bc of the Tuskegee Syphilis study? What did they do?
National Commission for Protection of Human Subjects of Biomedical and Behavioral Research
Component of National Research Act
Belmont Report
Research must respect volunteers (i.e., autonomy), accentuate beneficence, and demonstrate justice
1) What is the common rule?
2) What are 3 things/ regulations that apply to research?
1) Legally defines human subjects and other components of research
2) Office of Human Research Protection (OHRP)
Department of Health and Human Services
Health Insurance Portability and Accountability Act (HIPAA)
Explain IRBs
1) IRB and monitoring board should be independent from investigators to protect human subjects
2) Ethics + study protocol review
3) Data and Safety Monitoring Board: Reviews trends of unblinded or study arm of trials
The IRB must include (45 CFR 46) what four things?
1) At least 5 members from relevant academic disciplines or experiences
2) At least one member not otherwise affiliated with the institution
3) At least one member with scientific expertise
4) At least one member who is a “non-scientist”
Explain informed consent
1) Ongoing dialogue intended to provide sufficient information so that the individual can make his/her own decision about research participation
2) Persons with diminished autonomy require special safeguards to prevent their exploitation in research
Define assent
Assent: Pediatric patients can assent to treatment, but cannot consent to treatment
What does the Declaration of Helsinki say about placebo control?
1) The use of placebo, or no treatment, is acceptable in studies where no current proven intervention exists; or
2) “Where for compelling and scientifically sound methodological reasons, the use of placebo is necessary to determine the efficacy or safety of an intervention and the patients who receive placebo or no treatment will not be subject to any risk of serious or irreversible harm. Extreme care must be taken to avoid abuse of this option.”
Explain phase 1 trials
1) Some subjects, especially those with limited means, may discount the potential risks to reap the financial reward
2) Conversely, patients with the disease being studied usually are not paid, and may be subject to additional co-pays or other charges from a clinical trial
What are conflicts of interest?
Researcher’s financial or other personal considerations may compromise, or appear to compromise, the investigator’s professional judgment in conducting or reporting research
1) What is quality improvement?
2) What is genetic research?
1) Quality improvement
Explicitly is not done on a voluntary basis but rather is an operational implementation on the part of healthcare organizations
IRB review requirements are not in place for these types of projects, as they are not considered human subjects research
2) Genetic research
Informational risks, such as discrimination, psychological harm, or harm to family relationships if the results of the genetic testing became known to outsiders in case of a failure to keep the information secure
1) Do all clinical trials need to register?
2) What does globalization have to do with studies?
1) All clinical trials must register; not all data is published
2) Adequate infrastructure for oversight/monitoring of clinical research in foreign countries
Cultural differences
“Parachute Research” – exploitative research in underdeveloped countries
What terrible experiment Occurred before Belmont Report ?
Stanford Prison Experiment (Zimbardo 1971)
Explain the Facebook Emotional Contagion study (Kramer et al. 2014)
One group was shown mostly positive content and another group was shown mostly negative content
Researchers then studied the “emotional contagion” effect of whether individuals subsequently posted positive or negative items themselves
