Samenvatting
Samenvatting Lecture 2 - Clinical Trials and Clinical Development AM_1180 (AM_1180)
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- Vrije Universiteit Amsterdam (VU)
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Lecture 2The first trial was in the old testament. The case group was killed because the investigator
wanted to be right.
In the 1800s the first placebo trial was conducted:
1863→ The first comparative placebo controlled trial
1891→ First rule for regulation on clinical trials
1906 Pure Food & Drug Act USA→ First real legislation in the US. First legislation
was about commercialization and not how to develop things. It didn’t say a lot, was more
about branding and marketing, and products moving between states.
1937 Elixir sulphanilamide→ Sulphanilamide using diethylene glycol, which is
poisonous. The US governments couldn't get it off the market because there was no law.
Eventually they got it off market because of mislabeling. This lead to the Food, Drug &
Cosmetic act which states that products have to be researched (1938)
1940-1945 WOII→ Research was done without informed consent (most of the
victims were Jews, Poles, Russians, and Roma). Particularly also on twins
1946 – 1947 The Nuremberg Trials→ American military tribunal opened criminal
proceedings against 23 leading German physicians and administrators for their
willing participation in war crimes and crimes against humanity.
1947 The code of Nuremberg→ 10 standards to which physicians must confirm when
carrying out experiments on human subjects in a new code that is now accepted worldwide.
This code recognizes that doctors should avoid actions that injure human patients. The
biggest part is informed-consent. Inform people of what they will do to them. Remained as an
ethical code rather than a law
1957 Thalidomide Tragedy→ Thalidomide is an anti-nausea and sedative drug; was
tested in rats and couldn't find fatality. It was used as a sleeping pill and against
morning sickness. 1962, teratogen (birth defects).
1964 Declaration of Helsinki→ The World Medical Association (WMA) has
developed the Declaration of Helsinki as a statement of ethical principles (set up by
physicians for physicians). They advise others who work in clinical trials to live up to these
rules. Code of Nuremberg→ result is the declaration of Helsinki. The
document is being revised and updated. It was widely accepted until 1991. It contains
information about informed consent and legally authorized representative.
2013 version Declaration of Helsinki- principles:
- Medical research is subject to ethical standards that promote and ensure respect for
all human subjects and protect their health and rights
- The goal to generate new knowledge can never take precedence over the rights and
interests of individual research subjects
- Appropriate compensation & treatment for subjects who are harmed in research must
be ensured
, The committee must: be transparent and independent in its functioning, take into
consideration the applicable laws and regulations & applicable international norms and
standards, have the right to monitor ongoing studies
The researcher must: provide monitoring information to the committee, provide information
about serious adverse events, not implement any amendment without consideration &
approval, submit final report containing a summary of the study’s findings & conclusions
The use of placebo: Use of placebo is a big issue stated in the declaration of Helsinki.
If you take part in the trial, you have the right to the best proven treatment.
1972 The Tuskegee Syphilis Experiment→ The natural progression of syphilis
(government supported). For participating in the study, the men were given free medical
care, meals, and free burial insurance. They were never told they had syphilis, nor were they
ever treated for it, there was no cure at the time. In the 50s there became a cure available
(penicillin), while still not telling the subjects which disease they had they did not give them
this new treatment either. This was a scandal and led to the Belmont report.
1979 Belmont report→ The protection of Human Services of Biomedical and
Behavioral research: the Commission’s report “Ethical Principles And Guidelines
for the Protection of Human Subjects of Research”. The Belmont Report is one of
the leading works concerning ethics and health care research. It allows for the
protection of participants in clinical trials and research studies. The three
fundamental ethical principles for using any human subjects for research are:
1. Respect for persons: protecting the autonomy of all people and treating them with
courtesy and respect and allowing for informed consent. Researchers must be truthful
and conduct no deception
2. Beneficence: The philosophy of "Do no harm" while maximizing benefits for the
research project and minimizing risks to the research subjects
3. Justice: ensuring reasonable, non-exploitative, and well-considered procedures are
administered fairly — the fair distribution of costs and benefits to potential research
participants — and equally.
This is the first good clinical practice guideline that has been released and what went into
law.
1981 US Code of Federal Regulations (45 CFR part 46)→ First GCP guideline
was incorporated in the US law (45 CFR part 46), then UK, France and Japan
1990 ICH Established→ ICH, International Council for Harmonization, was
pioneered by the European Committee (EC), now the European Union. They write
regulatory requirements. These were written by the US, EMA and Japan by
regulatory people. At the first ICH Steering Committee (SC) meeting of ICH, the Terms of
Reference were agreed and it was decided that the Topics selected for harmonization would
be divided into: (these are the basis for approving and authorizing new medicinal products)
● Safety→ Deal with preclinical trials; only safe products are used on people
● Quality→ Manufacturing a quality product
● Efficacy→ Clinical trials
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