Summary
Samenvatting Clinical Trials and Clinical Development AM_1180 (AM_1180)
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Lecture 1What is a clinical trial?
● Involving human subjects→ investigates new methods of preventing,
diagnosing or treating disease
● Interventional studies have to live up to more requirements than a non-interventional
study.
● There are industry (commercial) and non-industry trials (done by academia)
● Sponsor of clinical trials is the party that takes responsibility for the study, overall
conduct, outcome, organization and set up of the trial. Also provide the money, but
they do not have to pay themselves, others can do this. They just take the overall
responsibility.
Which parties are involved?
● Sponsor→ not responsible for the quality of the data, will only verify the data
● Investigator/site→ responsible for the research on site. Investigator is responsible for
the ongoing of the trial
● Institutional Review Board/Independent Ethics Committee
(IRB/IEC)→ depends on where in the world you are, which one you use. Ethics
committee forms an opinion
● Regulatory Authorities/Health Authorities→ a governmental agency that
regulates businesses in the public interest.
○ European Medicines Agency (EMA)
○ Competent Authority (CA)
○ Food and Drug Administration (FDA)
○ Pharmaceuticals and Medical Devices Agency (PMDA)
Vendors: individuals or companies that sell goods or services to other individuals or
companies. They are typically suppliers of raw materials, finished products, or specialized
services.
● Can be small, independent businesses or large corporations
● Can sell their goods or services directly to consumers or to other businesses as part
of a supply chain
● Manufacturers, wholesalers, retailers, and service providers.
● CRO (Contract Research Organisation) → hired on contract basis by the
companies to outsource their R&D activities that are time consuming,
costly and require specific expertise
● SMO (Site Management Organization) → specialized CRO, responsible for
managing and coordinating all aspects of clinical trial conduct at a specific
site (site= where participant is being treated)
● Central laboratory→ performs standardized laboratory tests on samples
collected from multiple study sites as part of a clinical trial
● IVRS (Interactive Voice Response System) → interacts with a user through
the use of voice. Used to manage patient randomization, treatment
assignment, and medication dispensing
● IWRS (Interactive Web Response System) → interacts with users through a
web-based interface to automate the collection, management and
processing of information. Used for the same purpose as IVRS.
1
, ● Central ECG (electrocardiogram) reading → ECG data collected from multiple
study sites is reviewed and interpreted by a central laboratory
Which tasks are involved?
● Set objectives/hypothesis for trial → product has clinical benefit of provides
safety for a particular disease indication
○ Different trials have different objectives/hypothesis
● Development of protocol and other trials related documents
● Recruitment of subjects→ fully consent can only be given if they are fully
informed
● Management of execution of trials
○ With new trials is first marketing the trials to attract participants, this is the
conduct phase
● Data analysis→ already set how you will analyze the date before hand
3 phases of a trial
Trial preparation Trial execution Trial analysis & reporting
Ready to start Database lock (DBL) Clinical study
enrolling subjects report (CSR)
1. Preparation:
- Development/collection essential documents
- Site selection
- Obtaining IEC/CA approval
- Site initiation
- Report writing
2. Execution:
- Site Management activities
- Routine monitoring visits
- Updating essential documents
- Report writing
- Query resolution
- Close-out visits
3. Trial analysis & reporting:
- Administrative tasks
- Filing
- Updating databases
Sponsor R&D → research and development activities that are conducted by the
sponsor of a clinical trial. Sponsor’s R&D activities includes:
● Monitoring/Site Management
● Data management
● Statistics
● Medical writing
● Drug Safety/Pharmacovigilance → process of monitoring the safety of
drugs, reporting and tracking of adverse events
2
, ● QA (Quality assurance)
● Regulatory affairs
Sponsor non-R&D → activities that are conducted by the sponsor of a clinical trial that
are not directly related to research and development.
● Sales & marketing
● Medical department (head: medical director): Supporting sales and R&D
● Financial department
Clinical trial team → actual conductors of the trial
● Trial manager
● Clinical research associates
● Clinical train administrators
● Line managers
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, Lecture 2
The 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
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