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Samenvatting lecture 1 - 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.
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