Exam 1 - Julia's Quizlets Flashcards
1
Q
What are the types of research
A
Basic (biological)
Applied
Clinical
Translational
Patient-centered
Epidemiological
Behavioral
Pharmacy practice and policy
Comparative effectiveness
(Please ACCEPT Blind Boys)
2
Q
What is basic (biological) research comprised of
A
Biochemistry
Genetics
Biology
2
Q
What is applied research comprised of
A
Pharmaceutics
Medicinal chemistry
Pharmacology
Pharmacotherapy
(PMPP)
3
Q
What is clinical research comprised of
A
- includes research involving human participants; either specimens from them or the humans themselves (eg behavioral studies)
- research clinical trials are required for FDA approval
4
Q
What is translational research
A
Utilizes technology and innovation along with new practices
5
Q
What is biomedical research
A
Involves biological and medical sciences to understand and improve the health of patients and populations
6
Q
Types of biomedical research
A
Basic research
Applied research
7
Q
Basic research (biomedical)
A
- systematic study directed toward fuller knowledge/understanding of phenomena and observable facts without specific applications towards processes/products in mind
- usually conducted in labs to provide knowledge of natural phenomenon
8
Q
What are the areas of inquiry of basic research
A
Biology
Genetics
Physiology
Biochemistry
(Babes Get Pointy Boobs)
9
Q
Why is basic research imperative for applied research
A
Knowledge must exist before it can be applied
9
Q
Applied research
A
- systematic study to gain knowledge/understanding necessary to determine how a recognized and specific need may be met
- utilized to develop a product/application like new meds, drug regimens, services
10
Q
How is applied research conducted
A
In animals and other living systems to solve a problem/create a product
11
Q
What are the areas of inquiry for applied research
A
Pharmacology
Medicinal chemistry
Pharmaceutics
(Pretty Mia Pino)
12
Q
Describe the development component of drug development
A
Systematic application of knowledge/understanding, directed toward production of useful materials/devices/systems/methods
13
Q
Define research and development
A
Creative work undertaken on a systematic basis to increase stock of knowledge including:
- knowledge of man
- culture and society
- use of stock knowledge to devise new applications
13
Q
Limitations of research and development
A
- time consuming
- very expensive
- takes ~15 years for new product to enter market
- average cost = ~$2B
14
Q
What is clinical research
A
Defined by NIH as:
Research that either 1. Directly involves a particular person/group of people or 2. Uses materials from humans (ex behavior, samples of tissue)
15
Q
What does clinical research help us understand
A
application of knowledge for products or processes in the:
- prevention
- diagnosis
- prognosis
- treatment
- cure
Of diseases in humans
16
Q
What type of research does clinical research encompass
A
Patient oriented research
Epidemiological
Health services research
(HEP)
17
Q
Patient oriented research (clinical)
A
Examines in humans:
- mechanisms of disease
- effects of drug therapies & interventions
- utilization of tech & devices in humans
18
Q
Epidemiological (clinical)
A
Also includes behavioral research which evaluates distribution and factors associated with:
- diseases
- health behavior
- health in general
19
Q
Health services research (clinical)
A
Evaluates effectiveness and efficiency of:
- treatment interventions
- services in real world practice
20
Q
What is pharmaceutical practice and policy research a component of
A
Health services research
21
Q
Define pharmaceutical practice and policy research
A
Multidisciplinary field of scientific investigation that examines cost/access/quality of pharmaceutical care from these perspectives:
- clinical
- socio-behavioral
- economic
- organizational
- technological
22
Which areas of pharmacy are within the scope of pharmaceutical practice and policy research
Pharmaceutical
Pharmacist services
Pharmacy systems
23
What is the goal of pharmaceutical practice and policy research
Increase knowledge of pharmaceuticals, pharmacist services, and pharmacy systems for individuals/populations
24
What are some new areas of pharmaceutical practice and policy research
- pharmacoepidemiology
- pharmacoeconomics
- pharmaceutical outcome research
- pharmacy practice based research
25
Comparative effectiveness research
Aims to generate and synthesize evidence that compares the benefits/harms of alternative methods
26
What is the goal of comparative effectiveness research
Provide info to decision makers at individual and population levels
26
What are the findings of comparative effectiveness research used for
Prevent/diagnose/treat/monitor a clinical condition or to improve delivery of care
27
Translational research
- transferring knowledge across the research and practiced continuum
- applying discoveries in labs & preclinical studies to the development of trials and studies in humans
- aims to enhance adoption of best practices in the community
28
Empiricism
- collection of info based on human experience
- info derived from sensory experience
28
Which disease states could translational research be essential for
Ex. Cancer & AIDS
Diseases that are in need for products to cure
29
Patient centered outcomes research (PCOR)
Helps patient communicate and make informed healthcare decisions
Allows the pt’s voice to be heard in assessing value of healthcare options
30
Research topics funded by PCORI
- assessment of prevention, diagnosis, and treatment options
- improving access and care in healthcare systems
- communication and dissemination research for shared decision making
- addressing disparities in prevention, diagnosis, or treatment effectiveness
- accelerating pt centered outcomes research and methodology research
30
What was created to fund research in order to generate evidence for pt centered care outcomes
Patient centered outcomes institute (PCORI)
31
4 determinants of scientific methodology
Theory
Objectivity
Empiricism
Ethics
(TOEE)
32
Objectivity
NO bias in any aspect of research including:
- definition
- measurement
- design
- analysis
33
Theory
- provides understanding/explanation of natural phenomena
- provides rationale & logic for research question and hypothesis
34
Steps in scientific research process
- develop research questions & hypothesis
- develop & implement research plan
- perform data collection & analysis
- prepare research report
35
Sources used to develop research question
Policy
Current issue
Theory
Literature
Clinical practice
(Point Cassie Towards Loser Central)
36
Desirable characteristics of a research question
Feasible
Interesting
Novel
Ethical
Relevant
(FINER)
37
Considerations when formulation a research question
Environment
Resource availability
Access to pt data
(in your research question ERA)
38
PICOTS framework for development of a clinical question
Patient/population
Intervention
Comparator
Outcomes
Timeline
Setting
39
ECHO framework used in pharmaceutical practice and policy research
Economical
Clinical
Humanistic
Outcomes
39
Descriptive research
Describes/explores population characteristics
Ex. Prevalence of a disease
40
How is research typically classified
Descriptive
Analytical
41
Analytical research
Evaluations relationship between 2+ variables for the purpose of explanation/prediction
42
Hypothesis
- typically developed in clinical research
- specifies expected/proposed relationship being evaluated between intervention and outcome
43
Research design classifications
Experimental
Observational
44
Experimental research design
Strongest design to test a research hypothesis
44
Research design
Overall plan allowing researchers to gather answers to study questions and test study hypotheses
45
Research methodology
Provides details on data collection and measurement techniques
45
How is research methodology grouped
Primary methods
Secondary methods
45
Observational research design
Provide evidence of associations/relationships
Ex. Cohort studies, cross-sectional studies
46
Primary methods
Specific data collection using self-reported observations, biological assessments
(Ex. Surveys, lab tests)
47
Statistical analysis
- quantitative answers to research questions
- organizes, summarizes, and analyzes data
- includes descriptive measures such as mean, median, mode
- includes inferential statistics such as t-test and analysis of variances (used to make inferences on population)
47
Which sections are included in a research report
Introduction
Methods
Results
Discussion
48
Evidence based medicine steps
1. Asking an appropriate and answerable question
2. Finding evidence
3. Appraising evidence
4. Applying evidence to practice
48
Secondary methods
Use of previously collected data for purposes such as pt care or reimbursement
Ex. Medical charts/claims
48
What types of research communication tools are useful for presentations
Abstracts
Posters
Papers
(APP)
49
What are the aims of EBM
Ensure delivery of highest quality pt care
50
Under the umbrella of EBM, according to the institute of medicine, what should quality healthcare be
Safe - avoid pt harm
Effective - care should benefit pt
Patient centered - care should be individualized based on pt preferences/values
Timely - ensure timely, needed care and avoid delay
Efficient - maximizes use of healthcare
Equitable - does not vary due to personal beliefs/practices
(STEEEP)
51
What does the accreditation council for pharmacy education (ACPE) require of pharmacist training
- principles of research design and methodology
- regulatory and ethical principles of research
- data management and statistical analyses
- principles of drug literature evaluation
- practice implication of research
(Pretty Dumb People R Pharmacists)
52
What are the aims of the clinical and translational science award (CTSA) program
- develop academic infrastructure for translating biomedical research to treatments
- involve community practitioners and industry in translational research
- train the next generation of clinical and translational researchers
53
Practice bases research
- can be instrumental in clinical and translational research
- the practice based research network (PBRN) consists of clinicians, dentists, nurses, pharmacies
54
How can the PBRN be instrumental
- ID problems in pt care
- test effectiveness of treatments in real world settings
- evaluate patients who can benefit from treatments
55
Drug development process
- preclinical
- phases 1-4
- randomized controlled trials are gold standard
- INDA and NDA submissions
- post marketing research
(PRIPP)
56
Phase I clinical trial characteristics: primary interest
Toxicity/tolerability
57
Phase I clinical trial characteristics: Target population
Healthy volunteers OR subjects w/ the disease in question
58
Phase I clinical trial characteristics: Study design
- dose escalation in cohort of patients
- often uncontrolled
- generally unblinded
59
Phase I clinical trial characteristics: Duration
~ 1 month to > 1 yr
60
Phase II clinical trial characteristics: primary interest
Preliminary efficacy and safety
61
Phase I clinical trial characteristics: Volunteers enrolled
~50
62
Phase II clinical trial characteristics: Target population
Subjects w/ disease in question
63
Phase II clinical trial characteristics: Study design
Can be:
Randomized
Double blind
Placebo
Controlled
64
Phase II clinical trial characteristics: Duration
Months, up to 2 years
65
Phase II clinical trial characteristics: Volunteers enrolled
~ 100
66
Phase III clinical trial characteristics: primary interest
Efficacy and safety
67
Phase III clinical trial characteristics: Target population
Subjects w/ disease in question
68
Phase III clinical trial characteristics: Study design
Can be:
Randomized
Double blind
Placebo
Active controlled
69
Phase III clinical trial characteristics: Duration
1-2 years, up to several years
70
Phase III clinical trial characteristics: Volunteers enrolled
100s to 1000s
71
Phase IV clinical trial characteristics: primary interest
Long term data
72
Phase IV clinical trial characteristics: Target population
Could include subjects w/ other diseases
73
Phase IV clinical trial characteristics: Study design
Various depending on intent
Experimental/observational designs
74
Phase IV clinical trial characteristics: Duration
Variable
75
Phase IV clinical trial characteristics: Volunteers enrolled
Varies
75
Consent issues as they relate to ethics and respect for persons
Autonomy/self-determination
Voluntariness
Confidential/privacy
Elements of consent
Informed consent form
Consent process
(A Very Cold ICE)
76
Who are considered vulnerable subjects
Children
Decisionally impaired persons
77
Beneficence
- risk/benefit analysis issues
- data & safety monitoring plans/boards
- special populations such as limiting risks in children
78
Justice
- fairness in the distribution of burdens and benefits
- issues
- recruitment practices
79
Regulatory framework for clinical research
Codes/reports
US federal regulations (FA, OHRP, HIPAA)
ICH/GCP
Definitions of human subjects research
IRB systems of review
Role of IRB and IRB membership
IRB approval considerations
Continuing review
Amendments
Human Research Protection Programs (HRPPs)
SAE reporting unanticipated problems involving risk to subjects and others
(I HID At CIRCUS)
80
Ethical challenges in clinical research
- Placebo ethics
- Ethical issues w/ Phase I trials
- Conflicts of interest
- QI vs research
- Ethical issues w/ tissue & data banking
- Privacy/confidentiality issues
- Public registries of clinical trials
- Genetic testing in clinical research
- Globalization of clinical research
(Good Girl PEEP, Cat Princess)
81
How can a good research design impact research findings
Increases the validity of research findings
82
What are the ramifications of a flawed research design
Could raise questions about the credibility of research findings
83
Purpose of clinical studies
Well designed
Provide valuable evidence to assist practitioners in making decisions that best suit patient needs
83
Which factors are essential to evaluate and apply research evidence
Understanding of research designs and methodology
84
What are the issues w/ poorly designed research studies
- limited scientific value
- can be useless/wasteful/harmful to patients when incorporated into evidence based practice
84
What is the decision to use a particular study design dependent on
The ability of that design to provide valid results
84
How do clinicians practice EMB
Integrate their own clinical experience w/ the best available clinically relevant research
84
What does validity reflect
Accuracy of study results
84
What does the development of research design allow researchers to do
Gather answers to study questions and test study hypotheses
84
Which two types of validity exist
Internal validity
External validity
85
Internal validity
Extent to which the dependent variable (clinical outcome of interest) in a study is caused by the independent variable (treatment)
85
Causation
AKA causality
One of the most commonly used terms in scientific literature
Represents a cause and effect relationship
85
External validity
Refers to the extent to which the results of a study can be generalized to other settings
85
When does causality exist
When there is a causal relationship between the treatment (cause) and the clinical outcome (effect)
86
9 criteria for causation
Analogy
Coherence
Consistency
Experiment
Plausibility
Temporality
Specificity
Strength
Biological gradient
(ACCEPTS Some Bitches)
86
Two broad categories of research designs
Observational
Experimental
86
Which type of criteria can be used to classify research designs
Study purpose
Time orientation
Investigator orientation
Clinical/experimental setting
(STIC)
87
Observational designs
- researcher observes interplay of independent variables w/ dependent variable
- variations in exposure and outcomes are observed to evaluate their relationship or association
87
Experimental designs
- researcher controls treatment (independent variable) that is likely to have an effect on clinical outcome (dependent variable)
- criteria such as temporality, strength, biological gradient can be easily achieved to prove causality
88
Investigator orientation criteria
Interventional
Quasi-experimental
88
Time orientation criteria
Prospective
Retrospective
88
Study purpose criteria
Descriptive
89
Experimental setting criteria
Randomized controlled trials
Observational
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