History and Evolution of Clinical Research
Ethics questions and answers
Earliest recorded clinical trial - ✅✅Conducted by King Nebuchadnezzar II, 605-562 BC.
Ambroise Parè's trial - ✅✅First novel therapy trial in 1537 for wounds.
James Lind's experiment - ✅✅First controlled trial using lemon juice, 1747.
Placebo use - ✅✅Emergence of placebo in 19th century trials.
False therapeutic claims regulation - ✅✅1912 US Congress prohibits misleading medicine labels.
Randomization in trials - ✅✅Introduced in 1923, subjects assigned randomly.
Therapeutic Trials Committee - ✅✅Established in 1930 to manage clinical trials.
US drug safety regulation - ✅✅First regulation in 1938 by Food, Drug, Cosmetic Act.
Multicenter studies - ✅✅First introduced in 1944, using same protocol.
Properly randomized trial - ✅✅Conducted by MRC in 1948 for tuberculosis.
Nuremberg Code - ✅✅Established ethical standards for medical experimentation.
Kefauver-Harris Drug Amendment - ✅✅1962 regulation requiring proof of drug efficacy.
Hygienic Table - ✅✅Harvey Wiley's experiments on food additives' safety.
, US Food and Drugs Act of 1906 - ✅✅First law against misbranding and adulteration.
Sulfanilamide Tragedy - ✅✅1937 disaster leading to stricter drug regulations.
Elixir Sulfanilamide - ✅✅Untested drug causing over 100 deaths in 1937.
Nazi medical experiments - ✅✅Controversial human experiments during World War II.
Investigational use labeling - ✅✅Introduced in 1938 for study drugs.
FDA authority expansion - ✅✅Gave FDA power to inspect drug manufacturing.
Control groups - ✅✅Parallel groups used in clinical trials for comparison.
Blind trial - ✅✅Participants unaware of treatment received.
Statistical power - ✅✅Increased by pooling results from multicenter studies.
Therapeutic claims - ✅✅Statements regarding the effectiveness of treatments.
Chemical preservatives - ✅✅Substances added to food to prevent spoilage.
Adulteration - ✅✅Adding inferior substances to food or drugs.
Misbranding - ✅✅False or misleading labeling of products.
Ethics questions and answers
Earliest recorded clinical trial - ✅✅Conducted by King Nebuchadnezzar II, 605-562 BC.
Ambroise Parè's trial - ✅✅First novel therapy trial in 1537 for wounds.
James Lind's experiment - ✅✅First controlled trial using lemon juice, 1747.
Placebo use - ✅✅Emergence of placebo in 19th century trials.
False therapeutic claims regulation - ✅✅1912 US Congress prohibits misleading medicine labels.
Randomization in trials - ✅✅Introduced in 1923, subjects assigned randomly.
Therapeutic Trials Committee - ✅✅Established in 1930 to manage clinical trials.
US drug safety regulation - ✅✅First regulation in 1938 by Food, Drug, Cosmetic Act.
Multicenter studies - ✅✅First introduced in 1944, using same protocol.
Properly randomized trial - ✅✅Conducted by MRC in 1948 for tuberculosis.
Nuremberg Code - ✅✅Established ethical standards for medical experimentation.
Kefauver-Harris Drug Amendment - ✅✅1962 regulation requiring proof of drug efficacy.
Hygienic Table - ✅✅Harvey Wiley's experiments on food additives' safety.
, US Food and Drugs Act of 1906 - ✅✅First law against misbranding and adulteration.
Sulfanilamide Tragedy - ✅✅1937 disaster leading to stricter drug regulations.
Elixir Sulfanilamide - ✅✅Untested drug causing over 100 deaths in 1937.
Nazi medical experiments - ✅✅Controversial human experiments during World War II.
Investigational use labeling - ✅✅Introduced in 1938 for study drugs.
FDA authority expansion - ✅✅Gave FDA power to inspect drug manufacturing.
Control groups - ✅✅Parallel groups used in clinical trials for comparison.
Blind trial - ✅✅Participants unaware of treatment received.
Statistical power - ✅✅Increased by pooling results from multicenter studies.
Therapeutic claims - ✅✅Statements regarding the effectiveness of treatments.
Chemical preservatives - ✅✅Substances added to food to prevent spoilage.
Adulteration - ✅✅Adding inferior substances to food or drugs.
Misbranding - ✅✅False or misleading labeling of products.
