Clinical Research Trials
Understanding what clinical research trials and research studies are, and why they are important to the NIH.
Egwuagu: The Clinical Center at the NIH is the largest hospital in the world devoted to clinical research, and almost all of the patients cared for at the clinical center are also participants in clinical research trials and research studies. Dinora Dominguez, Chief of the Patient Recruitment and Public Liaison Office for the NIH Clinical Center defines research study and clinical research trial.
Dominguez: So research studies if you will is sort of the umbrella because research studies then is divided then into clinical trials with individual patients. A research study can be any type of research that's being done in the outside world and that could be sociology, anthropology, any type of medical, of course, and device research study. But a clinical trial is what we predominantly concentrate on and that is where you are dealing with individuals, with human beings, and they are participating in a study related to a very specific question that an investigator or their team wants to find the answer to.
Egwuagu: There are many different types of clinical trials. A type of clinical trial that is specific to the Clinical Center is a natural history study.
Dominguez: That is looking at somebody through the years and what's the natural course if you will of the condition, of the disease, the diagnosis that they are looking at. Then there are clinical trials that actually start from phase zero all the way through phase four.
Egwuagu: Each phase helps researchers answer different questions. For example phase one would evaluate safety and identify side effects, and phase four would continue safety tracking and optimal use.
Dominguez: So the phase zero through four, really they are looking at a medication or a device or a different—or a medication that's already been approved for one condition.
Egwuagu: But a very important part of the trials is the participants. Dominguez emphasizes, that without the participants there would be no way to perform the clinical trials.
Dominguez: If we don't have the participants, we're not going to go anywhere and that's the key of the relationship that we have this it really is a partnership. It's a partnership between the research team headed by the principal investigator and the participants. Whether the participants are individuals with medical conditions of whether they are individuals that are healthy, we need them and they need us to move science forward.
Egwuagu: An important thing about clinical trials is that a patient or volunteer has the right to say no, and not participate. Dominguez adds that another important part of the trials is that it is a continuous process.
Dominguez: It's not just that one time that you sign a document and then you're done at that's it, but that it's really a process that you want to be involved in and you want to have conversations with all of the individuals that are providing research care for you. I think also that it's necessary for all of us to participate, whether it's as a healthy, whether it's as an individual with a specific medical condition or diagnosis because it's really the way that we can advance science.
Egwuagu: If you would like more information about participating in a clinical research trial, please visit the website clinicalresearchtrials.nih.gov. You can also go to clinicaltrials.gov or call 1-800-411-1222 for information about clinical research trials that are currently recruiting participants. For NIH Radio, this is Emeka Egwuagu— NIH...Turning Discovery Into Health®