Exam 1 - Research and Ethics Flashcards
Basic research
Systematic study that aims to expand knowledge of a subject or phenomenon WITHOUT specific applications in mind (how, what why)
Ex. Biology, physiology, biochemistry, genetics
(Uses the basic topics [because those are classes we already took^^] for research)
Biomedical research
Research in biological and medical sciences to understand and improve the health of patients
Applied research
Systematic study to gain knowledge or understanding necessary to determine the means by which a recognized and specific need may be met (find solutions to problems; develop new med)
Ex. Pharmacology, medicinal chemistry
(Applying pharmacology and medicinal chem to find new solutions)
Clinical research
Involves humans as study subjects; useful for understanding products for prevention, diagnosis, treatment, and cure of diseases in humans
Pharmaceutical practice and policy research (clinical research)
Deals with issues related to:
- pharmaceuticals
- pharmacist services
- pharmacy systems
Translational research
Transferring knowledge across the research and practice continuum
3 ways translational research is accomplished
- applying discoveries to clinical research
- adoption of best practices
- adopt evidence-based patient care practices
What diseases is translational research most essential for
Cancer
AIDS
Empiricism
Collection of info based on human experience
All aspects of science should be observed and measured to be considered scientific evidence
Objectivity
There is no subjectivity or bias in any aspect of research including:
- definition
- measurement
- design
- analysis
Theory
Provides an understanding or explanation of a natural phenomenon
Provides the rationale and logic for research questions and hypotheses
Ethics
Provides the moral societal standards for responsible research conduct, being:
- respect
- fairness
- wellbeing of research participants
Who governs ethics of research conduct
Institutional Review Board (IRB)
Steps in research/scientific inquiry
Research question & hypothesis
Research plan
Data collection & analysis
Research report
Evidence based medicine
Integration of best research evidence w/ clinical expertise & patient values (translate scientific evidence to pt care)
2 types of research plans
Experimental: RCTs
Observational: cohort or cross-sectional studies (weaker due to bias)
Phase I clinical trials
Testing drug in a small group of humans w/ intent of establishing the initial toxicity profile of the substance
Pre-clinical studies (drug development)
Drug candidates are tested in animal models of the disease for pharmacologic effects and toxicity
Promising candidates are selected for clinical testing in humans
Phase II clinical trials
Randomized trials involving ~100 participants & short term studies (<1 yr) are designed to provide the preliminary safety and efficacy
Phase IV clinical trials
AKA post-marketing studies
Used to generate longer-term safety/toxicity data
Phase III clinical trials
Randomized control trial often involving blinding and placebo
Hundreds of thousands of subjects
Can be long term (over 1 yr)
Safety/efficacy data obtained to see risk/benefit relationship
What is the gold standard for conducting clinical research
Randomized controlled trials
_____ oversees development of new drugs, governed by _____ regulations
FDA
IND
When a sponsor believes drug development data will sponsor drug approval, it is submitted as a ____ for FDA approval
NDA
