Clinical Trial Protocols
A document outlining objectives, design, and methodology of a trial.
What is a clinical trial protocol?
Characteristics required for enrollment.
What are inclusion criteria?
Any unwanted effect that occurs during a clinical trial.
What is an AE - adverse event?
Represents R&D
What is Research and Development?
This kind of FDA legislation provided incentives for developing drugs for rare diseases.
What is the Orphan Drug Act of 1983?
This person is in charge of the entire clinical trial protocol?
What is the principal investigator of the clinical trial?
Factors that disqualify a participant.
What are exclusion criteria?
An event causing hospitalization, disability, or death.
What is a SAE - serious adverse event?
Represents FDA
What is the Food and Drug Administration?
This FDA department regulates drugs.
Main outcomes used to measure treatment effectiveness in a clinical trial.
What are primary endpoints of clinical trials?
It ensures generalizability of results across populations.
What is recruitment diversity in clinical trials?
This committee oversees safety and efficacy data during a trial.
What is the Data Monitoring Committee?
Represents a condition affecting fewer than 200,000 people in the U.S.
What is an orphan disease?
This FDA department regulates biologics.
What is CBER - Center for Biologics Evaluation and Research?
Additional outcomes that provide supporting evidence.
What are secondary endpoints of a clinical trial?
These factors --distance, cost, mistrust, and lack of awareness -- do what to clinical trial enrollment?
What are limiting factors to clinical trial participation?
Usually need to be reported within 24–72 hours for serious events.
What are AE and SAEs - adverse events and serious adverse events?
This application must be approved by the FDA in order for a drug to enter the market.
What is an NDA - New Drug Application?
Prescription, generic, and over-the-counter drugs are monitored by this FDA department.
What is CDER - Center for Drug Evaluation and Research?
A substitute measure predicting clinical benefit (e.g., blood pressure for heart disease).
What is a surrogate endpoint?
Access to new treatments and medical care is an example of WHAT to participating in clinical trials.
What are benefits to participating in clinical trials?
These individuals are responsible for reporting adverse events of clinical trials.
What are investigators and sponsors of the clinical trial?
This reduces FDA review time from 10 months to 6 months for a drug.
What is priority review?
Blood products, vaccines, gene therapy, and cellular products are monitored by this FDA department.
What is the CBER - Center for Biologics Evaluation and Research?