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Understanding Clinical Trial Regulations (2023)

The most valuable piece of any clinical trial is the patient. Patients willingly provide their time to researchers to help advance the field of medicine. However, research often comes with risks and patients have a right to be protected as fully as possible against those risks. This is the role of the Food and Drug Administration (FDA): they are the regulatory authority responsible for safeguarding public health and human rights. As we move through the process of conducting a clinical trial, the FDA enforces strict guidelines on any investigators researching medicinal products in the United States (US). We’ll guide you through understanding the FDA’s clinical trial regulations.

The Clinical Trial Lifecycle

When a sponsor intends to investigate an investigational drug on human subjects, they must submit an investigational new drug application (NDA) to the US FDA. The NDA serves to provide all relevant information on the sponsor’s planned clinical trial, including documents such as the investigator’s brochure, study protocol, previous human experiences with the drug, and more.  Following submission, this application is forwarded to the right division team for further review.

Typically, the FDA approves the start of clinical activities 30 days after it’s received. Although this timeframe can be longer if there are many review comments to address, in which case the NDA is put on clinical hold. The FDA also allows shorter approval paths, such as breakthrough therapy, accelerated approval, and fast track, for unique drugs which fill an unmet need for serious conditions. After 30 days, the sponsor can also begin importing their investigational product and initiating the trial. Once the first human patient is enrolled, the clinical trial must be registered on ClinicalTrials.gov after 21 calendar days.

What is an Institutional Review Board?

As the FDA reviews a sponsor’s submitted IND, the institutional review board (IRB) simultaneously conducts a thorough ethics assessment of the proposed investigation. The IRB committee must consist of at least five qualified members from diverse backgrounds so that a proposal can be reviewed objectively and completely. Ethics committees exist to protect the rights of human participants during clinical research conduct. Ethics committees are particularly important in the NDA review process when it involves vulnerable populations, such as pregnant women, minors, or prisoners. IRBs weigh potential risks with benefits carefully in the interest of ensuring patient safety, particularly with informed consent. Clinical trials can only begin once it receives approval from the ethics board. This initial approval doesn’t necessarily expire, but it’s common practice for a periodic review to occur no less than once a year.

The Importance of Informed Consent

The core of ethically conducted clinical trials hinges on the ability of participants to freely give informed consent. The FDA determines what makes up proper consenting using Good Clinical Practice (GCP) guidelines, an international standard for ethics in clinical research. According to GCP guidelines, investigators must first clearly provide the details of a research study in simple language to prospective participants; this document is called the informed consent form (ICF). Once the patient has all the information needed to decide, they are given ample time to do so without pressure or coercion. As the ICF is revised throughout the study, all patients must be re-consented to the newest version to ensure GCP compliance. Like any other study materials which may be provided to a participant, ICFs cannot be implemented by sponsors or sites until they have been approved by the IRB.

The Sponsor’s Role

International guidelines, including GCP, define a sponsor as an individual who is responsible for overseeing and starting a clinical research study. This definition can apply to a person, such as physicians, or institutions, such as pharmaceutical companies. In the latter case, the sponsor doesn’t carry out the investigations themselves. In many cases, especially recently, sponsors have also been transferring their duties, partially or entirely, to contract research organizations (CROs). GCP guidelines do allow this, but the process must be documented in writing. In either case, sponsors are still ultimately responsible for maintaining quality assurance and quality control of clinical trial data, while ensuring that data privacy is fully protected throughout their study.

Conclusion

Clinical trials are complex research projects which are required to adhere to strict regulatory measures at every step of their lifecycle. These regulations are imposed primarily by the FDA in the US to ensure a proposed study is designed appropriately. Parallel review by IRBs is also mandatory in the case of most NDA submissions to ensure patients are protected against potential risks associated with research participation. CROs like Vial work closely with sponsors to ensure their studies are carried out with the utmost care and respect for patients. Connect with us to find out more about how we can help get your clinical trial off the ground successfully.

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