At first glance, it’s abbreviation soup – EMA, FDA, NIHR, OHRP, IRB – but this collection of organizations is responsible for making sure clinical trials are run properly, to protect patients and develop medicines that are safe and effective.
FDA, IRB, EMA… What Role Do Agencies Play In Clinical Trials?
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FDA, IRB, EMA…
what role do
agencies play in
clinical trials?
B l o g p o s t
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At first glance, it’s
abbreviation soup – EMA,
FDA, NIHR, OHRP, IRB –
but this collection of
organizations is
responsible for making
sure clinical trials are run
properly, to protect
patients and develop
medicines that are safe
and effective.
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2 0 2 1 . A l l R i g h t s R e s e r v e d
2 0 2 1 . A l l R i g h t s R e s e r v e d S i r o n C l i n i c a l
However complex it seems, it’s important to
understand the role of the agencies involved
in clinical trials, to ensure your trial complies
with regulatory requirements and keeps
participants safe. Let’s look at some of the
biggest agencies and other organizations
involved in clinical trials.
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United States
U.S. Food and Drug Administration (FDA)
The U.S. Food and Drug Administration (FDA) is “responsible for
ensuring the safety and efficacy of drugs, biological, and device
products in the U.S.”
Once a potential drug has been screened for safety and
pharmacological activity, and the researchers want to trial it in humans,
the FDA becomes involved in the development process. At this point,
the researcher needs to submit an Investigational New Drug (IND)
application. There are several types of IND application, depending on
the drug being developed and other factors. The FDA reviews the
application, particularly to ensure participants are not at unreasonably
high risk, and only with the FDA’s approval can the trial begin.
The FDA also provides approval of the drug after completion of the
clinical trial, with confirmation from the Center for Drug Evaluation and
Research (CDER).
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Institutional Review Board (IRB)
An Institutional Review Board (IRB) ensures that the clinical trial in question is ethical and that participants’ rights and welfare
are protected.
Any trial overseen by the FDA must be reviewed, approved and monitored by an IRB, which consists of physicians,
researchers and members of the community. Their role is to make sure risks related to the research are minimized and
“reasonable” compared to the potential benefits. One specific task of the IRB is to review informed consent documentation.
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Center for Drug Evaluation and
Research (CDER)
The Center for Drug Evaluation and Research
(CDER)’s role is to ensure “that safe and
effective drugs are available to improve the
health of people in the United States.”
CDER is part of the FDA and acts as the
consumer watchdog for drugs. CDER gets
involved in the drug development process
when clinical trials are completed – experts
assess the results of clinical trials prior to FDA
approval. As stated on the CDER website,
To read the complete blog, please head to:
https://sironclinical.com/role-of-agencies-in-
clinical-trials/
