Clinical Research

Overview of Clinical Research

Clinical research is a critical aspect of advancing medical knowledge and improving patient care. It involves carefully conducted investigations aimed at discovering new treatments, improving existing therapies, and understanding diseases better. At Southeast Kidney Associates, our clinical research program is designed to contribute to advancements in nephrology, with a focus on kidney disease, hypertension, dialysis, and related conditions. Through clinical trials and studies, we explore new ways to treat kidney disease and improve the quality of life for our patients.

By participating in clinical research, patients have access to cutting-edge treatments that are not yet widely available, allowing them to benefit from the latest innovations in nephrology care. Our team of nephrologists and research staff is dedicated to ensuring that all research is conducted ethically, safely, and with the highest level of care for participants.

What is Clinical Research?

Clinical research refers to studies conducted with human volunteers (participants) to evaluate the safety, efficacy, and outcomes of medical interventions such as new medications, devices, procedures, or behavioral therapies. The goal of clinical research is to advance medical science by determining whether these interventions are effective and safe for use in the general population.

There are different types of clinical research, including:

• Clinical Trials: These studies test the effectiveness of new treatments, medications, or interventions by comparing them to standard treatments or placebos.
• Observational Studies: In observational studies, researchers observe the health outcomes of participants without actively changing or intervening in their care.
• Diagnostic Research: This type of research focuses on improving diagnostic techniques or discovering new ways to detect diseases early.

At Southeast Kidney Associates, our clinical research focuses primarily on kidney-related conditions such as chronic kidney disease (CKD), acute kidney injury (AKI), dialysis, hypertension, and kidney transplantation. We work with patients who are interested in contributing to medical advancements by participating in research studies that could lead to new and improved treatments.

Why Participate in Clinical Research?

Participating in clinical research offers several benefits for patients, including:

1. Access to New Treatments: Clinical trials often provide participants with access to new medications or therapies that are not yet available to the general public. For patients with chronic or advanced kidney disease, this can be an opportunity to try innovative treatments that may be more effective than current standard care.
2. Expert Care: Participants in clinical trials are closely monitored by experienced healthcare professionals, including nephrologists and research staff. This ensures that any changes in health are detected early, and participants receive high-quality care throughout the study.
3. Contribution to Medical Science: By participating in clinical research, patients play a key role in advancing medical knowledge and helping future generations of kidney disease patients. The results of clinical research can lead to new treatments, better patient outcomes, and improved understanding of kidney health.
4. Personal Involvement in Healthcare Decisions: Patients who participate in clinical research often feel more involved in their healthcare decisions, as they are actively contributing to the development of new treatments and therapies.

How to Prepare for a Clinical Research Appointment

If you’re considering participating in clinical research at Southeast Kidney Associates, it’s important to be prepared for your initial consultation and research screening. Here’s how you can prepare:

1. Review the Study Details: Before your appointment, review the study information provided by the research team. This will include details about the purpose of the study, what will be involved, and the potential benefits and risks of participation.
2. Medical History: Bring a detailed list of your medical history, including any past diagnoses, surgeries, and treatments. Your nephrologist will review this information to determine whether you meet the eligibility criteria for the study.
3. Current Medications: Make a list of all medications you are currently taking, including prescription drugs, over-the-counter medications, supplements, and vitamins. This is important because some studies may have restrictions on the use of certain medications.
4. Questions for the Research Team: Prepare a list of questions or concerns you have about participating in the study. It’s important to fully understand what’s involved and what you can expect during the research process. Some questions you might ask include:
   • What are the potential benefits of participating in this study?
   • What are the risks or side effects of the treatment being studied?
   • How long will the study last, and how many visits are required?
   • Will there be any costs associated with participation, and are travel expenses covered?
   • How will my personal information be protected during the study?

5. Support System: Consider discussing your participation in clinical research with family or friends who can provide support and accompany you to appointments if necessary. Having a support system in place can help ensure you stay on track with the study’s requirements.

What to Expect During the Clinical Research Process

At Southeast Kidney Associates, we ensure that every participant in our clinical research program receives compassionate care and thorough guidance throughout the research process. Here’s what you can expect:

1. Screening and Eligibility: Before enrolling in a clinical trial, you will undergo a screening process to determine if you are eligible to participate. This process includes a review of your medical history, current health status, and any medications you’re taking. Some studies may require blood tests, imaging, or other diagnostic tests to confirm your eligibility.
2. Informed Consent: If you are eligible for the study, you will be asked to provide informed consent. This is a critical step where the research team will explain the details of the study, including its purpose, potential risks and benefits, and your rights as a participant. You will have the opportunity to ask questions and ensure you fully understand what participation involves before signing the consent form.
3. Baseline Assessment: Once you’ve enrolled in the study, a baseline assessment will be conducted. This may include physical exams, lab tests, imaging studies, or questionnaires to establish your current health status before the study treatment begins.
4. Study Participation: During the study, you will follow a specific schedule of visits, treatments, and tests as outlined in the study protocol. Depending on the type of research, you may receive the investigational treatment, a standard treatment, or a placebo. You will be closely monitored for any side effects or changes in your health. Your safety and well-being are the top priorities, and the research team will adjust your care if any concerns arise.
5. Follow-Up and Monitoring: Throughout the study, you will have regular follow-up visits to monitor your progress and ensure that the treatment is safe and effective. These visits may involve blood tests, urine tests, imaging studies, or other assessments. The frequency of follow-up visits will depend on the study’s design.
6. Post-Study Care: Once the study concludes, you will have a final assessment to evaluate the results of the treatment. The research team will provide recommendations for any ongoing care or additional treatments if needed. In some cases, participants may be able to continue receiving the investigational treatment after the study through an extended access program.

Patient Safety and Ethical Considerations

At Southeast Kidney Associates, patient safety is our top priority. All clinical research conducted at our facility follows strict ethical guidelines and is approved by an Institutional Review Board (IRB) to ensure that the rights and well-being of participants are protected. Our research team is committed to conducting studies in accordance with the highest standards of medical ethics, ensuring that all participants are treated with respect and transparency.

Conclusion

Clinical research plays a vital role in advancing medical knowledge and improving treatments for kidney disease and related conditions. At Southeast Kidney Associates, we are proud to offer our patients the opportunity to participate in clinical trials that may provide access to innovative therapies and contribute to the future of nephrology care. If you’re interested in learning more about our clinical research program or participating in a study, contact us today to schedule a consultation and explore your options.