Healthcare professionals know that research is essential to find safer and more effective ways to prevent, diagnose, and treat kidney diseases. However, patients may need explanation and encouragement to understand their important role and participate.
Patients Are Partners in Research
During a presentation at the NephCure 2025 Patient Summit and Youth Summit in New York City titled Empowering Patients in Research, From Participant to Partner: Understanding Clinical Trials, Purva Sharma, MD, director of glomerular disease trials and research division at Northwell Health, offered a helpful overview of the information patients may need.
“Traditionally, patients were viewed as subjects who provided data. Now, there’s a growing recognition of the value of their lived experience. Patient partners bring unique insights into the challenges of living with kidney disease, such as the impact on daily life, symptoms, and treatment burdens,” Dr. Sharma said. “A true partnership between researchers and patients is needed for this process to succeed.”
Types and Phases of Clinical Trials
Dr. Sharma offered a brief synopsis of the types and phases of clinical trials, which clinicians can use to help patients understand the research realm.
- Behavioral trials evaluate ways to promote behavioral changes that improve health.
- Screening and diagnostic trialsexamine procedures to screen or test for diseases and conditions.
- Prevention trialsseek ways to avoid the development or recurrence of diseases or conditions, which may include medications, vaccines, and lifestyle changes.
- Quality-of-life trials,also known as supportive care trials, explore strategies to improve patients’ comfort and daily lives.
- Treatment trialstest new treatments or combinations of treatments.
Dr. Sharma said patients also may need a brief overview of the four phases of clinical trials.
- Phase 1 involves small patient samples to establish initial safety.
- Phase 2 further evaluates safety and aims to establish effectiveness in a larger group of patients.
- Phase 3 compares a new approach to the current standard of care in a large patient group.
- Phase 4 occurs after a new approach is approved and on the market. It involves long-term monitoring regarding risks, benefits, and optimal use in real-world settings.
Safety Requirements and Informed Consent
Patients often ask whether trials are safe and ethical, Dr. Sharma said. Healthcare professionals can explain that all research must be reviewed and approved by an institutional review board and follow certain guidelines and protocols to protect participants. Studies also must keep patient information private and confidential, stored in a database that can be accessed only by the research team.
Importantly, patients have the right to informed consent, which ensures that they understand all aspects of a trial before they decide whether to participate. This may include information about the purpose of the study; what the researchers hope to learn; the study procedures; potential risks and benefits; and patient rights, including the right to withdraw from the study at any time.
Throughout a study, the research team monitors patients closely and encourages them to report side effects. Patients also have the right to receive information about study findings that may affect their health or well-being.
Finding Trials in Kidney Disease
The following resources offer information on clinical trials in kidney disease for patients:
About the Event
The NephCure Patient Summit is designed for individuals affected by rare kidney diseases, including patients, caregivers, families, advocates, and healthcare partners. To learn more about NephCure or to participate in future NephCure events, visit nephcure.org.
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