Clinical trials can sound intimidating, especially if you’re already managing chronic kidney disease (CKD). But here’s the truth: clinical trials in the U.S. are built on multiple layers of safety, oversight, and ethical protection to help keep participants safe while advancing better treatments for people like you.*

How Clinical Trials Protect You

Clinical trials in the United States are tightly regulated. Before any study begins, it must be reviewed and approved by:

• The U.S. Food and Drug Administration (FDA), which reviews safety data and decides whether a trial can move forward
• An Institutional Review Board (IRB), which is an independent panel of doctors, researchers, and everyday community members

The IRB’s job is simple: Protect you. They make sure the study is ethical, that the risks are reasonable, and that your rights and well-being come first.

Even once a trial starts, the IRB continues supervising it, and any sign of unexpected risk can pause or stop the study immediately.

Because of these protections, clinical trials are often more closely monitored than everyday medical care.

How New Treatments Are Tested Before Reaching People

Before a treatment ever reaches human volunteers, it goes through years of lab and animal testing. Only when early research shows that the treatment has the potential to be safe and helpful does the research team ask the FDA for permission to study it in humans.

This request is called an Investigational New Drug (IND) application. The FDA reviews:

• lab research
• animal safety testing
• manufacturing processes
• study design and safety plans

Only then can early-phase human trials begin.

Why Trials Happen in Phases

Clinical trials are divided into phases so researchers can answer different safety and effectiveness questions step-by-step. Knowing the phase can help you decide whether a trial is right for you.

Phase I: Is it safe?

• Usually 20–100 participants
• Smallest and most closely monitored group
• Tests safety, side effects, and the right dose

These trials have the highest uncertainty but are often important for patients who need options not available yet.

Phase II: Does it work?

• Usually 100–300 people
• Tests whether the treatment helps the condition
• Continues monitoring safety

Phase III: How does it compare to standard treatments?

• 300–3,000 participants
• Compares a new treatment to what’s already available
• Looks at effectiveness, side effects, and long-term results
• Often the final step before FDA approval

These trials tell us whether a new treatment may offer better results or fewer side effects than today’s options.

Phase IV: What happens after FDA approval?

• Studies in people using the treatment long-term
• Looks at rare side effects, how it works in special populations (like CKD patients), or new possible benefits

So… Are Clinical Trials Safe?

No medical treatment is risk-free, but clinical trials are designed to minimize risks as much as possible. Every study has:

• strict eligibility criteria
• regular monitoring
• safety checks built into each phase
• oversight from federal agencies and independent experts

Many people choose clinical trials because they want access to promising new treatments, extra medical attention, and a chance to contribute to research that may improve care for themselves and others living with CKD.

If you’re considering a clinical trial, talk with your doctor, ask questions, and make sure you understand the potential risks and potential benefits. Your safety and comfort should always come first.

* National Kidney Foundation (2025). “Are Clinical Trials Safe?” kidney.org

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