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.
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.
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).
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.
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, “The Center’s review of new drug applications not only prevents quackery, but it provides doctors and patients with the information they need to use medicines wisely.”
Office for Human Research Protections (OHRP)
The Office for Human Research Protections (OHRP) “helps to protect the rights, welfare, and wellbeing of research volunteers.”
OHRP is part of the U.S. Department of Health and Human Services (HHS), which also includes the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC). OHRP oversees and enforces HHS regulations for protecting people in HHS-funded research.
Europe
European Medicines Agency (EMA)
The European Medicines Agency (EMA)’s mission is “to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health in the European Union (EU).”
The EMA has regulatory mechanisms for certain aspects of the testing and provision of medicines in the EU. While it does not have direct involvement in the clinical trials process, the EMA does encourage compliance with European Commission regulations for clinical research, such as the Clinical Trials Directive.
National agencies of Member States
The European regulatory structure is somewhat different to that in the US. While the US is a single country overseen in medicine-related regulation by the FDA, the European Union is made up of 27 member states, each with its own national agency.
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Medicines and Healthcare products Regulatory Agency (MHRA)
The Medicines and Healthcare products Regulatory Agency (MHRA) “regulates medicines, medical devices and blood components for transfusion in the UK.”
MHRA is sponsored by the UK’s Department of Health and Social Care. It is responsible for ensuring medicines meet relevant standards for safety, quality and efficacy – including through the authorization of clinical trials and the approval of medicines.
MHRA also has a role in communicating the risks and benefits of medicines and influencing national and international policy to protect public health.
Global
National regulatory authorities
The Danish Medicines Agency, Tanzania Food and Drug Authority (TFDA) and the Maltese Medicines Authority are just three of the national agencies around the world responsible for approving and regulating clinical trials and medicines.
The International Accrediting Organization for Clinical Research provides a list of national agencies.
At Siron Clinical, our experts have knowledge and experience of the clinical trials process in Europe and beyond. Contact us if you’re seeking more information or clarity on the potential roles of these agencies in your study.
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