L7 Clinical Trials Flashcards
(33 cards)
What is a clinical trial?
A research study that evaluates the effects of new tests and treatments on human health outcomes (WHO).
What interventions can clinical trials evaluate?
surgery, drugs, new technologies, machines, immunotherapies
Is participation in clinical trials mandatory?
No, it is entirely voluntary and ethically protected.
What international document governs ethical trial conduct?
The 1964 Declaration of Helsinki - a foundational document for ethical research involving human subjects in medical research. Emphasises the importance of protecting the well-being and rights of research subjects.
Who was Joseph Mengali and which impact did he have on clinical trials?
A Nazi doctor whose unethical experiments led to strict post-WWII trial legislation.
What did the Declaration of Helsinki emphasize?
respect for individuals, informed consent, and the right to withdraw.
What are the 5 main stages of drug development?
Discovery, preclinical research, clinical research, licensing review, post-market monitoring
What is preclinical research?
research involving in vitro (test tube) and in vivo (animal) studies before human testing.
What kind of animal testing is commonly used in preclinical research?
primates, dogs, and rodents
What does IND stand for?
Investigational New Drug application
What does the FDA require in an IND application?
Animal toxicity data, manufacturing info, human research data, protocols, and investigator info.
How long does the FDA have to respond to an IND submission?
30 days
Trial design - what questions must be answered in clinical trial design?
who participates, how many, duration, control group, bias prevention, dosage, endpoints
What is the purpose of clinical trial protocols?
Ensure ethical oversight, standardised methods, and public transparency
Who approves clinical trial protocols?
Institutional ethics committees (approval valid nationally)
What is the focus of phase 1 trials?
Safety and dosing, usually with patients who have no other options
What is the 3+3 design in phase 1?
A dose-escalation method where three patients are tested before increasing dose.
What is tested in phase 2?
Evidence that the drug works - efficacy in a larger group over months/ years.
What is the goal of phase 3?
Compare the drug to the current standard of care in hundreds of patients. Does the new drug work better or worse than those currently available?
What is phase 4?
Post-market monitoring for side effects not detected in earlier phases.
What happens after phase 3?
Submit a New Drug Application (NDA) to the FDA.
What is the Yellow Card system in the UK?
A way to report post-market drug side effects online
Why is a patent important post approval?
To recover the millions spent in drug development
What happened in the 2006 CD28 antibody trial?
Sever inflammatory response (cytokine storm) in the human subjects despite safe results in monkeys; 4 amino acid difference caused the reaction
