What Are Clinical Trials and Why Do They Matter?

Last Updated: April 30, 2025

In this article:

• Why Are Clinical Trials Important?

• Types of Clinical Trials

• Phases of Clinical Trials

• Who Can Participate in Clinical Trials?

• Benefits and Risks of Participating in Clinical Trials

• Questions to Ask Before Joining a Clinical Trial

Clinical trials are research studies conducted to evaluate new treatments, medications, or medical devices. They are crucial to advancing medical knowledge and improving patient care. Participating in clinical trials can provide access to innovative therapies that may not yet be widely available for patients with kidney disease.

Why Are Clinical Trials Important?

Clinical trials are essential for:

1. Developing New Treatments: They help researchers determine whether new medications or therapies are safe and effective.

2. Improving Existing Therapies: Trials can test whether existing treatments work better when combined or used differently.

3. Advancing Medical Knowledge: The data collected from clinical trials contributes to a better understanding diseases and how to manage them.

4. Providing Early Access to New Therapies: Patients who participate in clinical trials may gain access to cutting-edge treatments before they are approved for general use.

Types of Clinical Trials

Treatment Trials

Purpose: To test new treatments, such as medications, dialysis techniques, or surgical procedures.

Example: A study evaluating a new drug that slows the progression of chronic kidney disease (CKD).

Prevention Trials

Purpose: To find ways to prevent kidney disease or its complications.

Example: Research whether lifestyle changes or supplements can prevent kidney damage in people with diabetes.

Diagnostic and Screening Trials

Purpose: To improve methods for diagnosing or detecting kidney disease earlier.

Example: A trial testing a new biomarker that can identify kidney disease before symptoms appear.

Quality of Life Trials

Purpose: To explore ways to improve the quality of life for people with kidney disease.

Example: Studies on mental health interventions or dietary changes for dialysis patients.

Phases of Clinical Trials

Clinical trials typically go through four phases before a treatment is approved for widespread use:

Phase 1: Safety and Dosage

• Participants: A small group of healthy volunteers or patients.

• Purpose: To assess the safety of the treatment and determine the appropriate dosage.

Phase 2: Efficacy and Side Effects

• Participants: A larger group of patients with the condition.

• Purpose: To evaluate the treatment's effectiveness and gather more information on side effects.

Phase 3: Comparison and Monitoring

• Participants: Hundreds to thousands of patients.

• Purpose: To compare the new treatment with standard treatments and monitor its effectiveness and safety over time.

Phase 4: Post-Marketing Surveillance

• Participants: Patients using the treatment after it has been approved.

• Purpose: To monitor long-term effects and gather information on the treatment’s use in real-world settings.

Who Can Participate in Clinical Trials?

Every clinical trial has specific criteria that participants must meet. These are known as inclusion and exclusion criteria, and they ensure that the study results are accurate and meaningful.

Inclusion Criteria

These are the conditions that a participant must meet to join the trial, such as:

• Age range.

• Stage of kidney disease.

• Medical history.

Exclusion Criteria

These are factors that disqualify a person from participating, such as:

• Certain health conditions that could interfere with the study.

• Use of specific medications.

Benefits and Risks of Participating in Clinical Trials

Benefits

1. Access to New Treatments: Participants may receive innovative therapies before they are widely available.

2. Close Monitoring: Patients in clinical trials often receive more frequent check-ups and monitoring than during standard care.

3. Contributing to Medical Advances: Patients help researchers develop better treatments for future generations by participating.

Risks

1. Unknown Side Effects: Since new treatments are still being studied, risks or side effects may not yet be known.

2. No Guaranteed Benefit: The tested treatment may not be more effective than existing options.

3. Time Commitment: Participating in a clinical trial may require frequent visits, tests, and follow-ups.

Questions to Ask Before Joining a Clinical Trial

If you are considering participating in a clinical trial, ask your healthcare provider or the research team the following questions:

1. What is the purpose of the trial?

2. What treatments or interventions will I receive?

3. What are the potential risks and benefits?

4. How long will the trial last?

5. Will I need to pay for any part of the treatment?

6. How will my privacy be protected?

7. Can I leave the trial if I change my mind?