What is a Clinical Trial? With Olga Rios, RN, of the NHLBI

Leigh Clark:    00:00    Hi, everyone. This is Podcast for Patients with the Aplastic Anemia and MDS International Foundation. I'm Leigh Clark, Director of Patient Services. Our podcast series is brought to you with special thanks to the generous support from our patients, families, and caregivers like you, and our corporate sponsors. Thank you everyone for supporting this important series.
    00:26    Today, we're going to be talking about clinical trials with Olga Rios, who is a registered nurse at the National Heart, Lung, and Blood Institute in Bethesda, Maryland. Welcome, Olga.
Olga Rios:    00:41    Thank you for having me.
Leigh Clark:    00:43    Thank you. What is a clinical trial?
Olga Rios:    00:47    A clinical trial is a carefully designed research study conducted with patients to evaluate a new medical treatment, drug, or device. The purpose of a clinical trial is to find new and improved methods of treating, preventing, and/or diagnosing diseases or medical conditions. Some studies help evaluate the effectiveness and safety of medications or medical devices by monitoring their effects on groups of people. There are other studies that look at the natural history of a disease or condition, which allows us to learn more about the condition. Some people will come to NIH to participate in a research or sometimes to get a second opinion on their condition and may end up enrolling in a natural history study if one is available.
Leigh Clark:    01:40    Thanks, Olga. Why are clinical trials important?
Olga Rios:    01:45    Clinical trials are important because without them we wouldn't have new treatments and medical devices and people who volunteer to participate in them. Each trial works to answer scientific questions and help find better ways to prevent, diagnose, and/or treat a condition or disease. It's important to have diverse populations and older people participate also in clinical trials to promote health equity and reduce health disparities. When research involves a group of people who are similar, these findings aren't always beneficial to diverse or older populations. We're always working to diversify our research population and encourage everyone to consider participating. Even if you don't have a disease or condition to treat, you can participate in a research as a healthy volunteer. There are always research studies at NIH enrolling for many different studies. We often make discoveries by comparing healthy populations to people who have disease or condition, but it depends on how the study is set up.
Leigh Clark:    02:55    Thank you for that. How would someone find a clinical trial?
Olga Rios:    03:01    Clinical trials may be found for participation at the National Institutes of Health, university hospitals, physicians that are affiliated with a hospital or university medical program, independent physicians, and private medical and/or pharmaceutical industry. There are always new studies opening and on the horizon, and there are a number of ways to identify studies that might fit your needs. Clinicaltrials.gov and the NIH Clinical Center: Search the Studies websites are two of the best ways to locate clinical trials that may be enrolling patients. There are points of contact listed for every study. The best way to determine your best option is usually to talk to the research contact listed.
    03:49    Additionally, the NIH Clinical Center has an office dedicated to helping people find the most appropriate trial for each person, and they can route you to the appropriate study contact. You can find their information by Googling the NIH Clinical Center Office of Patient Recruitment, or you can call 1-800-411-1222, or email ccopr@nih.gov to ask about currently enrolling studies.
Leigh Clark:    04:22    Thanks, Olga, for that great information. What things should a patient look for in deciding if a trial is right from them?
Olga Rios:    04:32    So there are several things that a patient should consider when making the decision to participate in a clinical trial. The patient needs to ask themself if participation in a clinical trial will allow them to, one, gain access to new research treatments before they're widely available, two, obtain expert medical care at a leading healthcare facility during the clinical trial, three, potentially help others, and, four, help reduce treatment cost. Now, participation in a clinical trial is an important decision and should be made after thorough discussion with your doctor and your loved ones.
Leigh Clark:    05:14    Thanks, Olga. And how are clinical trials made safe?
Olga Rios:    05:20    Some trials are designed to asses safety of a new drug or medical device. These studies are classified as phase one trials. Other assess the most appropriate dosage of drugs or use of devices that have already been deemed safe, and these would be phase two, phase three studies. All clinical trials are overseen and approved by an Institutional Review Board, also known as an IRB for short, which exists to protect human subjects in research. There are strict guidelines to be followed by the team and by the institute that is sponsoring the study. Study participants may continue to work with their own healthcare team during the research study. Generally, participants in clinical trials are often more closely monitored than patients treated outside of clinical trials.
    06:12    Clinical trials have eligibility criteria to determine if the patient is appropriate and to ensure that they are protected. Doctors that involved in clinical research come from among the most knowledgeable about a disease or conditions since this is the focus of their work. The ethical and legal regulations that govern medical practice also apply to clinical trials. They are fairly regulated, carefully controlled, and have built in safeguards to protect participants.
Leigh Clark:    06:46    Thank you so much, Olga, for sharing your time and your expertise with all of us and providing this very insightful information about clinical trials. If you'd like to find out more about bone marrow failure diseases or clinical trials, you can visit our website at aamds.org, follow us on social media, uh, with our Facebook, Instagram, and Twitter, or you can give us a call on our helpline, 800-747-2820. This concludes our podcast session, and thank you so much, Olga, for sharing your time with us today.
Olga Rios:    07:28    Thank you for having me. My pleasure.