Patient Safety in Clinical Trials

Healthcare safety is a growing public health concern since we all will interact with the healthcare system at some point in our lives. Although clinical trials aren’t technically part of the healthcare system, participants do receive health care in similar ways. Those that participate may receive expert care by a team of doctors, nurses, and trained clinical research professionals, and may have access to current or investigational medications throughout the duration of a trial.

Patient Safety Week takes place this month, so we wanted to show you how clinical trials keep patients safe.

What is Patient Safety Week?

Patient Safety Week is held annually in March. Its purpose is to create awareness about patient safety and recognize the work already being accomplished. This year, the week is March 8th-14th, and the goal is “to advance important discussions locally and globally and inspire action to improve the safety of the health care system — for patients and the workforce.”

Why is Patient Safety Important in Clinical Trials?

Clinical trials collect data on the safety and effectiveness of new drugs, diagnostics, devices, and therapy practices. Healthy volunteers and patients are enrolled in studies to compare the new product or medication with currently available options.

Although every possible safety measure and test has been performed before trial enrollment, there is still some level of risk.

Patient Safety in Clinical Trials

How Trials Keep Patients Safe

Before being used in clinical trials, new interventions are first studied extensively in the lab and/or in animal studies. Trials can take place only after the FDA approves the trial process to begin.

The FDA’s Center for Drug Evaluation and Research (CDER) evaluates new drugs before they can be sold. They accomplish this by setting up review points before, during, and after the clinical trial process. Each study must follow the Good Clinical Practice (GCP) guidelines that oversee clinical research. The GCP guidelines ensure that trials ethically operate in the rights, safety, and welfare of patients and the collection of data.

Participants in clinical trials also go through an informed consent process before they can enroll. It confirms the participant understands the research and its risks.

Patient Safety in Clinical Trials

Advancing Patient Safety

We all have a role to play in improving patient safety. To see how you can get involved, visit the IHI’s patient safety page, here.

Choosing to volunteer in clinical research is an important and individual decision. You can learn more about participating, where our site locations are, and view a list of upcoming studies, by visiting us here.