L4 Evolution of Clinical Research Flashcards
(32 cards)
What are the 2 parts of assesments for clinical trials?
HPRA for safety/efficacy & quality
Ethic committees
What is the function of a clinical trial?
Seperate relative handful of discoveries which prove to be true advances in therapy from a legion of false leads & unverifiable clinical impressions & to delineate in a scientific way, the extent of, and the limitations which attend the effectiveness of drugs
What 2 studies assess if an intervention works?
Observational/retrospective studies
Prospective/interventional studies
What are the 4 phases of clinical trials?
Phase 0/1 - exploratory/human pharamcology (healthy volunteers)
Phase II - Exploratory Therapeutics (small group of intended pts)
Phase III - Confirmatory therapeutic (larger groups of pts)
Phase IV/post-approval - case by case
Define Ethics.
Framework for understanding & examining ‘moral’ decisions & evaluating rights & wrongs of human conduct
What is bioethics?
Application of ethical principles to biomedical & clinical research & practice
When was the first human subject reserach?
605 BC - Book of Daniel
What was the earliest sign of ethical awarness?
500BC Hippocrates ‘first, do no harm’
What was the Scurvy Trial?
By James Lind in 1753
Various scurvy cures tested - 12 men ate a common diet & slept together in 6 pairs
Orange and lemons
What was self-experimentation seen as?
Critical element for ‘proper’ research for both ethical & commercial reasons
What 5 requirements were used in Walter Reed’s yellow Fever Study in 1901?
Self-experimentation
Written contracts with participants
Payment in gold
Restricted to healthy adult (male) subjects
All publications should include the phrase ‘with his full consent’
What was evidence of informed consent in ancient greece?
Doctors required consent from ‘freeborn & highborn patients’ an ‘informed request’ to treat
What year did informed consent come around?
1900 - important limitations around human research
What were 3 downfalls of studies in 1900?
Not statistically rigorous
lack of objectivity
small study sizes
What were 2 acts for standards onf evidence
1906 - Wiley Act banned false or misleading claim on labels
1937 - Kefauver-Harris Amendments introduced legal pre-market evidence requirements
What vulnerable populations were not protected?
Prisoners
Orphans
Mentally imapired
What experiments were prisoners exposed to in Nazi Germany?
genetic & Racial Hygiene
Eugenics & racial eradication
Approaches of mass sterilisation
How many research categories were around in nazi Germany?
26
What 2 doctors were invloved in Nazi germany?
Dr Josef Mengele
Dr. Gerhard August Rose
What was Aktion T4?
Programme of systematic ‘involuntary Euthanasia
What was the Law of Prevention of Hereditarily Diseased Offspring in 1933?
Mandated sterilization for schizophrenia, epilepsy, HD, imbecility, chronic alcoholism
What did T4 implement?
Nazi Party of racial hygiene - Germany needed to be cleansed of ‘racial enemies’
What were the Nuremburg Trials 1947?
Nazi doctors, nurses & scientists were tried for their activities for the abuse & murder of concentration camp prisoners who were used as research subjects
What did the Nuremburg Code establish requirements for?
Informed consent
Absence of coercion
Risk/benefit assessment
Properly formulated scientific experimentation
Beneficence towards participants
Right of Withdrawal
Vulnerable/at risk groups
