Drug Regulation and Monitoring Flashcards
How can subject bias be countered during a clinical trial?
placebo
How can observer bias be countered in a clinical trial?
blinding, especially double blinding
What type of design can detect natural fluctuation of disease?
Cross-over design
________ of subjects counters the bias of selection.
Randomization
Phase I studies:
20-80 healthy patients
Intended to establish safety and tolerability
Focus included dosing and PK parameters
Often non-blinded=all subjects get drug
(if high levels of toxicity are expected patients with target condition may be used in place of healthy volunteers)
Phase II studies:
50-300 patients with the medical condition of interest
Objective= determine effectiveness of drug for a particular disease
Capable of detecting some AE
Dose response and dosing regimens
Usually involves a single-blind study, where drug is evaluated against placebo or standard of care
Several dosing options to obtain optimum doe range and toxicity info
May pinpoint data that must be collected in phase III
Phase III trials:
300-3000 patients and are conducted at multiple sites
Studies are based on specific clinical or surrogate endpoints
Randomized, controlled, double-blind trials with multiple arms
Results should provide adequate basis for extrapolating results to the general population
Accelerated development and approval of a drug for serious/life-threatening disease
Fast Track Status
Sponsor formally proposes that FDA approve new drug for sale in the US
New Drug Application
Sponsor submits preclinical research data to FDA to proceed with human clinical trials
Investigational New Drug Application
For disease that affects <200,000 pts in US, 7yrs exclusivity patent
Orphan Drug
Ensure the rights and welfare of clinical trial participants before and during the trial
Investigational Review Board
Meds in phase III development, gives access to patients who may not survive
Compassionate Use
Reviews safety/efficacy data on interim basis
Data and Safety Monitoring Board
Phase IV Studies:
Post drug approval studies
More info about side effects and safety of the drug when used in the general population
Long term risk/benefits
Efficacy when used in the general population
May be required by the FDA
True or False: A phased trial is needed for a generic drug to be approved for use.
False
Generic drugs must prove _________ to innovator drugs.
Bioequivalence = same absorption, distribution, metabolism, and excretion
(Same batch requirements for identity, strength, purity, and quality as the innovator drug)
Generic drugs must have the same _______ as the innovator drug.
Active
What is the purpose of MEDWatch?
To capture serious AE data post drug approval and report them.
Any person can report to MEDWatch
What are required risk management plans that use risk minimization strategies beyond the professional labeling to ensure that the benefits of certain Rx drugs outweigh their risk?
REMS(Risk Evaluation and Mitigation Strategies)
