History and Evolution of Clinical Research
Ethics questions and answers
Earliest recorded clinical trial
Conducted by King Nebuchadnezzar II, 605-562 BC.
First clinical trial of a novel therapy
Ambroise Parè's treatment for open wounds, 1537.
First use of control groups
James Lind's lemon juice experiment, 1747.
First use of a placebo
Emergence of placebo trials in the 19th century.
First regulations against false claims
USA Congress prohibits misleading therapeutic labels, 1912.
First use of randomization
Introduced in clinical trials, 1923.
First body to manage clinical trials
Therapeutic Trials Committee established in the UK, 1930.
First US regulation for drug safety
US Food, Drug, and Cosmetic Act, 1938.
First multicenter studies
Conducted under the same protocol, 1944.
First properly randomized clinical trial
British Medical Research Council's study on streptomycin, 1948.
King Nebuchadnezzar II
Ordered a diet trial with royal children, 605-562 BC.
Ambroise Parè
Renaissance surgeon who innovated wound treatment, 1537.
James Lind
Pioneered controlled trials for scurvy prevention, 1747.
, Placebo
Inactive substance used in clinical trials.
Randomization
Subjects assigned randomly to treatment groups.
Therapeutic Trials Committee
UK committee for managing clinical trials, 1930.
US Food, Drug, and Cosmetic Act
Established drug safety regulations in the US, 1938.
Multicenter studies
Studies across multiple sites using identical protocols.
Streptomycin
Antibiotic evaluated for tuberculosis treatment, 1948.
Blind trial
Participants unaware of treatment received.
Statistical power
Increased reliability from pooled study results.
Sanocrysin
Tested for tuberculosis in randomized trials.
Nuremberg Code
First ethical regulations for medical experimentation.
Declaration of Helsinki
Guidelines for medical research ethics, established 1964.
Kefauver-Harris Drug Amendment
1962 law requiring drug efficacy proof for approval.
US Food and Drugs Act of 1906
First law against misbranding and adulteration of foods.
Adulteration
Adding harmful substances to food or drugs.
Misbranding
Ethics questions and answers
Earliest recorded clinical trial
Conducted by King Nebuchadnezzar II, 605-562 BC.
First clinical trial of a novel therapy
Ambroise Parè's treatment for open wounds, 1537.
First use of control groups
James Lind's lemon juice experiment, 1747.
First use of a placebo
Emergence of placebo trials in the 19th century.
First regulations against false claims
USA Congress prohibits misleading therapeutic labels, 1912.
First use of randomization
Introduced in clinical trials, 1923.
First body to manage clinical trials
Therapeutic Trials Committee established in the UK, 1930.
First US regulation for drug safety
US Food, Drug, and Cosmetic Act, 1938.
First multicenter studies
Conducted under the same protocol, 1944.
First properly randomized clinical trial
British Medical Research Council's study on streptomycin, 1948.
King Nebuchadnezzar II
Ordered a diet trial with royal children, 605-562 BC.
Ambroise Parè
Renaissance surgeon who innovated wound treatment, 1537.
James Lind
Pioneered controlled trials for scurvy prevention, 1747.
, Placebo
Inactive substance used in clinical trials.
Randomization
Subjects assigned randomly to treatment groups.
Therapeutic Trials Committee
UK committee for managing clinical trials, 1930.
US Food, Drug, and Cosmetic Act
Established drug safety regulations in the US, 1938.
Multicenter studies
Studies across multiple sites using identical protocols.
Streptomycin
Antibiotic evaluated for tuberculosis treatment, 1948.
Blind trial
Participants unaware of treatment received.
Statistical power
Increased reliability from pooled study results.
Sanocrysin
Tested for tuberculosis in randomized trials.
Nuremberg Code
First ethical regulations for medical experimentation.
Declaration of Helsinki
Guidelines for medical research ethics, established 1964.
Kefauver-Harris Drug Amendment
1962 law requiring drug efficacy proof for approval.
US Food and Drugs Act of 1906
First law against misbranding and adulteration of foods.
Adulteration
Adding harmful substances to food or drugs.
Misbranding
