Clinical Trials

Why They Are Important, How They Work and How You Can Get Involved

 

Whether it’s through new or improved medicines, medical devices or treatment techniques, people with kidney disease have more options for treatment than ever. As we look to the future of treating kidney disease, we’re getting better at understanding how the disease affects people on an individual basis. Through new tools, technologies and discoveries, we’ll be able to provide more effective, personalized treatments. But no matter what breakthroughs are uncovered, it will all start with the patient — with someone like you.

The Importance of Clinical Trials

Every advance in kidney disease care has been made possible by research. Part of that research happens in clinical trials, which are studies to test the safety and effectiveness of medicines, medical devices and treatment techniques in people. Clinical trials are conducted to make existing treatments better or to develop entirely new treatments for kidney disease.

Each year, thousands of people volunteer in clinical trials. While some feel the act of participating is rewarding, many people volunteer for studies to learn more about their disease and to have the opportunity to help find better treatments for their disease. Volunteers also often find a strong sense of community with others in their position. Moreover, there are many helpful groups and associations — such as AAKP — that reach patients and connect them to one another.

How Clinical Trials Work

Clinical trials are carefully monitored. The absolute risk of any new product being tested is not known. For that reason, several agencies work to minimize the potential risk of these new drugs or devices by evaluating whether the known risks outweigh the potential benefits.

In the U.S., one of those groups is the U.S. Food and Drug Administration (FDA). The job of the FDA is to ensure the safety and effectiveness of new drugs and devices. The FDA reviews all data provided and decides whether that medicine, medical device or treatment technique being tested can move forward on the pathway to approval.

In addition, every clinical research study is reviewed by an investigational review board. These ethics committees ensure that all known potential risks, benefits and requirements of the study (including time, testing, etc.) are clearly stated so that you, the volunteer, can make an informed decision whether to participate in a study.

Ultimately, a kidney disease product or treatment can only be offered to patients after it has proven to be beneficial. Before that can happen, there are several phases to testing products and treatments, and each can take years of testing on thousands of people — this is why finding volunteers is so important for researchers. The process of developing a new treatment can take up to a decade or more. Therefore, the outcome of a research program you participate in may not be known for several years.

What You Should Know Before Joining a Clinical Trial

There are commitments when joining a study. For example, you may have to travel to a physician’s office or dialysis facility more often, or you may be asked to change your treatment schedule. Before joining a study you should talk through the details of the trial with your personal physician.

In any case, you’ll learn about all requirements before the study starts. You will also be asked to sign an “informed consent form.” This document tells you everything about the study, including what the risks may be. It will also tell you if there is any benefit you might receive by being part of that research study and whether costs for time and transportation will be covered. Once you’re informed, you can decide if you want to participate. Studies are voluntary, and you can withdraw at any time.

In many clinical trials, when you volunteer, you’ll also receive a full medical examination. This includes basic measurements, like height, weight and blood pressure. This may include analysis of blood and urine samples, or even more extensive tests like ECGs or ultrasounds. For many volunteers, joining a study is an opportunity to learn more about how their disease affects them. For example, you could participate in a study for kidney disease caused by diabetes.

How You Can Get Involved

There are many ways to learn about opportunities to join clinical trials. The best way is to talk to your doctor or care provider. You can also seek information from kidney disease research and support organizations, such as AAKP, or view online listings of clinical trials by visiting www.ClinicalTrials.gov.

No matter how you hear about a clinical trial, if you’re interested in volunteering, start by discussing your interest with a health care professional. Joining a trial isn’t for everyone, but for those who are able and willing to join a clinical trial, it can be a rewarding experience. Patients who have volunteered are gratified to know that their participation is helping to further research into finding more effective treatments for their diseases.