How is Clinical Research Regulated?

How is Clinical Research Regulated?

April 29, 2019

How is Clinical Research Regulated?

Clinical research has led to significant medical breakthroughs—in fact, all FDA-approved medications on the market today have undergone multiple phases of clinical trials with human volunteers before being released to the public.

In addition to being aware of their rights as a participant and informed consent, it’s also helpful for clinical research volunteers to understand how clinical trials are regulated to ensure that they are being conducted in safe, ethical ways.

Clinical Research Regulation

From the beginning stages of submitting an Investigational New Drug(IND) application to gaining FDA-approval(and even afterward), clinical trials are closely monitored by a variety of departments; three primary departments when it comes to clinical research are sponsors, investigators, and IRBs.

A clinical trial sponsor is the individual or company (typically pharmaceutical) that initiates and is responsible for clinical research proceedings. Among many other responsibilities, the sponsor must ensure that all aspects of the study are in compliance with FDA regulations. Additionally, they will carry out appropriate consequences upon any discovery of non-compliance.

The Principal Investigator(PI) is the individual in charge of conducting a clinical trial and ensuring that the study follows all regulatory requirements. The PI is also responsible for meeting all internationally recognized standards for Good Clinical Practice(GCP), which is defined as “an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials.”

An Institutional Review Board(IRB) is a group designated to review and study clinical trial protocols before they begin. In addition to ensuring that the rights and welfare of the participants are protected and follow FDA regulations; the IRB also pays attention to diversity and representation of the study group. They ensures that enough groups—especially minorities—are represented.

Clinical Research Oversight

A Data Safety Monitoring Board(DSMB), which is complementary to the IRB, is a group of research and study topic experts who review a clinical trial as it is taking place. The group is often comprised of ethicists, statisticians, and a medical expert specializing in the disease being researched. The DSMB looks for any discrepancies in safety for participants as well as results among certain groups of participants. If a clinical trial puts too many participants at risk or has the potential to cause harmful effects; the trial may be stopped altogether.

FDA Involvement in Clinical Research

Additionally, the FDA may be involved in a clinical trial at any time; whether it’s before completing an IND application, during the study for guidance purposes, or after the study to assess results. Within an FDA approval, there is a structured process including analysis of the disease in question and already available treatment, assessment of benefits and risks within the trial, and strategies for managing said risks.

Get More Information

Learn more about clinical trials by reviewing our Guide to Understanding Clinical Research Language or reading some Clinical Research FAQs. You can also contact us about any current volunteer inquiries, our methodologies, or any questions about the clinical study process.