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Health, Mind & Body Radio Program Host Marie Osbourne's Interview with Dr. Mark McClellan

This interview aired on WJR-AM in Detroit, plus 38 states.

Marie: If you've listened to this show for any length of time, or for that matter any health report you hear on the radio or on television, you often hear the word "clinical study" or "clinical trial." What is that?

So much of our healthcare today is based on those clinical trials, and we are delighted this evening for Health, Mind and Body, that Dr. Mark McClellan can join us.

He is the commissioner for the Food and Drug Administration. Welcome Dr., we are glad you can join us to talk about, what I always think one of the most important things in health news today, and that's clinical trials.

Dr. McClellan: Thank you Marie; I'm delighted to be with you.

Marie: And so many questions surround this. Why don't we first start by your defining for us, what is a clinical trial?

Dr. McClellan: Well, Marie, a clinical trial is a research study in people that is designed to answer specific questions about health and there are all kinds of questions that we want to know the answers to today. There are more new medicines in development than ever before. There is more scientific knowledge out there that could be brought to care and that can prevent diseases than ever before, more screening tests and diagnostic tests, but before they become widely used on people, we want to know is if they work. Clinical trials are the best way that we have to learn about what treatments really work to help people improve their health.

Marie: Now doctor, a lot of times, we hear stories about people who have a catastrophic disease or health problem and they want to get into a clinical trial, because they see that as perhaps their last best hope for survival and for health. Do you accept patients in that situation?

Dr. McClellan: Absolutely, there are clinical trials going on for a full spectrum of the illnesses and health risks facing our nation today. This includes very serious and life-threatening illnesses. There are many trials going on around the country for developing new treatments for Cancer, for Heart Disease, Strokes, Alzheimer's disease, and other very serious illnesses. But it's important to keep in mind that clinical trials cover the full spectrum, there are also preventive clinical trials going on now, that help people find better ways to prevent getting illnesses in the first place -- that people who are perfectly healthy can enroll in.

Marie: Now, when a drug is proposed, or is ready for clinical trial...How is the medical venue selected or the university or the medical facility selected in this country of ours, I mean there's a million places that have clinical trials...

Dr. McClellan: ... There are different research programs and they have different areas of specialization, so there are a number of research centers. Here in Detroit, Henry Ford Medical Center, for example -- which specializes in certain types of cancer -- is conducting trials in certain areas. Other medical centers may conduct other types of trials. It is true that it can be hard to find out exactly where a particular study is going on, and that's why we've taken steps at the FDA and with our partners at the National Institutes of Health and the National Library of Medicine to give people more information on just how they can enroll. And there's now a website that's up and running called ClinicalTrials.gov, it's all one word ClinicalTrials.gov where you can go and log on and get information on just about all of the federally-funded clinical research studies going on now, and a very large number of the privately-supported clinical research going on today all over the country.

Marie: ... and we'll have a link to that right here on our website at wjr.com at Health, Mind and Body. And when you talk about federally-funded clinical trials there are privately-funded ones, as you alluded to a few seconds ago, so these often are funded by drug companies, is that not true?

Dr. McClellan: They may be conducted by drug companies or there are a lot of new biotechnology companies that are just starting up. They are often formed by medical researchers who have found what looks like a good idea in the lab, and they want to take the next step to see if they can really work in people. All of these studies, whether they are publicly-funded or privately-funded, are overseen by the FDA to make sure that the researchers involved follow appropriate standards to make sure patients are well informed and they are not exposed to any un-known or unnecessary risks.

Marie: Well that brings us to, I think one of the most important questions and that is -- are the clinical trials safe?

Dr. McClellan: There are some risks associated with clinical trials. Just like there are some risks associated with many medicines in the market today. But what we try to do at the FDA is to make sure that people are well informed about any potential risks they might face and make sure that they are not facing any unreasonable risks. So for someone who is perfectly healthy in a prevention study, we would want to make sure that there is no substantial risk to their own health. For someone who has a very serious and life-threatening illness, where a major new surgical procedure or something like it is in development that may carry with it some risks and complications, we want to make sure that people are well informed about it. Again the risks are not disproportionate or they are not out of proportion to the potential benefit that they might get. We have a comprehensive system in place in this country to help oversee the safety and the ethical appropriateness of these trials.

Marie: ... and ethical appropriateness is my next question. And that is, if someone shows up or requests to be a part of a clinical trial, and researchers see that this person would be better served by having treatment XYZ some place else, is that information imparted to that patient?

Dr. McClellan: The patients are given information about the risks and benefits associated with their conditions and about the potential alternatives for treatment as part of the informed consent process. People need to be aware of what this treatment might do for them, as well as what might happen if they don't get the treatment.

Marie: How long has ClinicalTrials.gov been around?

Dr. McClellan: It's a fairly new site and it's one that we've been expanding significantly in recent weeks. So there are more studies listed than ever before. You can go to the site and click on a type of condition, your geographic location, things like that and it will present to you with a list of studies that are going on in your area that are enrolling patients in the studies right now. So it's a great way to find out about all of the opportunities out there for participating in research. I do want to emphasize again, that we are not just looking for people who are seriously ill in these studies. More than ever before, there are studies being conducted in patient populations that historically have not had as much evidence as we'd like, such as minority populations, populations of seniors, and women. The only way that we can find out if treatments really work is if we get the participation of the public and this is our tool to try to let the public know about the opportunities out there.

Marie: and when we talk about reported new advances in medicine and in health, we so often talk about clinical trials and where the research has been done and I always like to stress to people that you really need to examine how the clinical trials were done, where the research was done, and who did the research. It just takes a minute to really look up some of these references, but it will give you a clearer perspective on what's being touted like the latest, best thing, treatment of whatever.

Dr. McClellan: Yes, Marie, you are exactly right, that's exactly our philosophy here at the FDA, as you know, we do a lot of reviews on the clinical studies that are out there. That's what goes into the information that we put on the product label, the information that we try to get out to the patients about how they can use medicines safely and effectively. All the medicines out there do carry risks as well as benefits, and an informed consumer working with an informed professional is in a much better position to get the most out of modern medical technology.

Marie: Well, I was really glad to hear about ClinicalTrials.gov. I thought it was a great thing, we often get calls here people asking, especially unfortunately desperate people looking for some hope and some help, and it's really nice that we can give them a place to go now to look this up. Again, now it's ClinicalTrials.gov. And once again, people really do need to do their homework though, right Dr., before they engage in any clinical trial.

Dr. McClellan: That's right and we're trying to do all we can in the federal government to help to do their homework. In addition to the ClinicalTrials.gov website, we have a website at FDA, fda.gov that provides links to all kinds of clinically reviewed scientific information, which is very helpful for people trying to investigate just how to get the most benefits in their own health.

Marie: Dr. Mark McClellan, an MD and also a Ph.D., Commissioner of the Food and Drug Administration. Thanks for spending a little bit of time here and again we will happily put this on our website, ClinicalTrials.gov thanks again.

Dr. McClellan: Thanks Marie.