Coffee
What is Population, Intervention, Comparison, and Outcome
What is a test's ability to designate an individual with a disease as positive
Specificity
What is it's ability to designate an individual who does not have a disease as negative
CRAAPE
What is Currency, Relevancy, Authority, Accuracy, Purpose
MAARIE
What is Method, Assignment, Assessment, Results, Interpretation, Evaluation
Approves of the drug
Physicians
Nurses
Statisticians
Chemist
Pharmacologist
Lawyers etc.
the extent to which a test measures or predicts what it is supposed to
validity
consistency of measurement
reliability
a measure of how close a series of measurements are to one another
precision
A description of how close a measurement is to the true value of the quantity measured.
Accuracy
Type of Blinding
single blind - only the participant is unaware. of the treatment they receive
Double blind - the participants and the clinicians
Triple blind - participants clinicians and data collectors
Allows approval of a drug based on a surrogate endpoint or intermediate clinical endpoint.
accelerated approval
states there is a difference between two or more sets of data.
alternative hypothesis
a statement or idea that can be falsified, or proved wrong
null hypothesis
the process of carefully and systematically examining research to judge its trustworthiness, its value and relevance.
critical appraisal
is better than the available therapy
Breakthrough therapy
A type of epidemiologic study where a group of individuals with the diseases, referred to as cases, are compared to individuals without the disease, referred to as controls
Case-control study
A type of epidemiologic study where a group of exposed individuals (individuals who have been exposed to the potential risk factor) and a group of non-exposed individuals are followed over time to determine the incidence of disease
cohort study
respect for persons, beneficence, justice, autonomy
ethics in research
(expedite review of product)
Fast Track Designation
This type of drug is comparable to its original form in dosage from, strength, route of administration, quality, performance, characteristic, and intended use.
Is the drug ready for the big leagues, submitted when a drug is ready for early-stage clinical trials - moving from animals to humans. Must contain the following: Animal pharmacology/Toxicology studies - pre-clinical data, Manufacturing information - to ensure consistent production of the drug, Clinical Trial Protocols, Investigator Information.
IND- Investigational new drug application
Contains all data from the IND onward, Demonstrate that the drug is safe and effective for its intended use(s), Demonstrate that benefits outweigh risks, Demonstrate the labeling is appropriate, Manufacturing: methods are adequate to ensure consistent quality, purity, and identity, Animal Studies and Human clinical studies.
NDA - New Drug Application 10-month time clock
a procedure for statistically combining the results of many different research studies
meta-analysis
Name 2 areas that are investigated as part of an analytical inspection.
data integrity and data reliability.