Module 5 Study & Drug Development Flashcards
Study & Drug Development
This phase of study uses only a few small doses of a new drug in a few people. They often test how the drug acts in the human body and how it responds.
PHASE 0
This phase of studies of a new drug are usually the first that involve people. These studies are done to find the highest dose of the new treatment…
PHASE 1
The trials in this phase are designed to see if the investigational product works in participants with the disease of condition under investigation.
PHASE 2
These trials involve several hundred to several thousand participants. They are intended to answer the question question, is this treatment as improvement?
PHASE 3
What is the importance of bench evidence in drug development
To determine the stability of the drug during shipment and storage
What is the importance of preclinical evidence in drug development
To provide initial safety data for FDA approval
The trials in the phase study the side effects caused over time by a new treatment after it has been approved and is on the market
PHASE 4
Can endpoints include all types of data capture. i.e. quality of life surveys, specimen samples needed at specific timepoints?
YES
What is the benefit of using schemas in clinical trials
They help plan for the intensity and timeline of the study
Why are test schedules important in clinical trials
The provide a detailed list of required tests and procedures
T/F
The main difference between the observational and experimental study design is that observational studies don’t include any interventions while experimental studies involve adding a treatment or procedure
TRUE
What is a randomized clinical trial (RCT) used for in experimental study designs?
To compare the results between a control group and a control group and a treatment group.
What is single blinding in clinical trials
only the participant is blinded
What is double blinding in clinical trials
participant and study team are blinded
What is triple blinding in clinical trials
participant, study team, and data interpreters are blinded.
T/F
A placebo is generally used when the treatment period is short and lack of treatment of the medical condition is not expected to have clinically relevant impact
TRUE
Eliquis is being monitored for long-term safety and effectiveness in preventing blood clots.
Which phase of clinical trial is this?
PHASE 4
T/F
The primary objective of Phase 3 trials is to test to see if the drug is an improvement from the current standard
TRUE
A description of the trial design should include (3)
A description of (3)
- Specific statement of the primary endpoints and the secondary endpoints, if any, to be measured during the trial
- Measures taken to minimize/avoid bias
- the type/design of the trial to be conducted and a schematic diagram of trial design, procedures, and stages.
T/F
Pragmatic trials aim to test whether an intervention works under optimal situations
FALSE
Which phase of clinical trials primarily focuses on assessing the safety and dosage of a new drug in a small group of healthy volunteers?
PHASE 1
