Clinical Trials: Where to Find Published Quality Clinical Trial Results
Guest: Dr. Terry O’Brien – Cardiology
Host: Dr. Pam Morris – Cardiology
Dr. Pam Morris: Hi, this is Dr. Pam Morris. I am here today with Dr. Terry O’Brien who is Professor of Medicine and Director of Clinical Cardiovascular Research at the Medical University of South Carolina. We are talking about clinical trials for the development of new devices and medications, in particular for management of cardiovascular disease. Dr. O’Brien, how does a patient consider the quality of published results from a clinical trial?
Dr. Terry O’Brien: What a superb question, Pam. All of us, physicians and patients alike, are inundated with 10 different clinical findings in the media per day, the latest therapies for cancer, heart disease, gout. If one were to listen to all of these, one would think we would have many more cures than we actually do. Patients need to judge the quality of media information and perhaps I can give you some insight as to how physicians do. The first level, or major meetings, when research is announced, generally by experts in the field, and this is sort of an awareness of a finding, it does not mean it is the bottom line, it can be exciting but it does not necessarily change how we treat patients.
Dr. Pam Morris: So, this would be like at a meeting for the American Cancer Society or the American College of Cardiology?
Dr. Terry O’Brien: Absolutely. These findings are exciting and many times the media portrays them on the front page. But, patients have to understand that this is a preliminary finding and although exciting, needs to be confirmed.
Dr. Pam Morris: What would be another way that you could judge? After you have seen in the media that there is a possibility that a new medication or device is of benefit, how can you determine whether that really was a quality finding?
Dr. Terry O’Brien: I think that patients need to understand that physicians get much of their information from published medical journals. To publish a clinical trial in a major medical journal involves several layers of reviews by experts, ethicists, statisticians, you name it. If you publish a finding in a major journal, physicians generally accept it as fact. That is how you and I, and many of us, get our information, the more preeminent the journal, usually the better the clinical trial. This leads to other important sources of information for patients. Probably the best one is their physician because he or she knows them and knows their disease process and can interpret information for them. Also, patients need to understand that successful advances eventually make their way to availability through the FDA approving a medication or device. This involves having repeated, positive clinical studies with an appropriate safety margin.
Dr. Pam Morris: I think, also, an interesting aspect of the publication of results is the subsequent editorial letters, where findings are then scrutinized by physicians and we are then able to respond by letters as to our opinion of the importance of those findings. And, often times, I think that the public, the lay person, is not always made aware of the fact that ongoing debate may continue in the medical field itself.
Dr. Terry O’Brien: That is absolutely true. One of the strengths of our medical system is the ability to criticize and bring new ideas, whether it be a letter, a response, or a new idea to be tested, or whether it be new side effects or new therapeutic effects that are brought to attention after a medication is on the market. All of this dialogue and investigation is actually a strength of our medical system. In fact, it is responsible for much of the success patients have enjoyed over the past few years.
Dr. Pam Morris: Let’s talk about research that is currently ongoing in the division of cardiology here at MUSC. What are some of the areas that we are actively investigating?
Dr. Terry O’Brien: Well, Pam, as you know, we are a leading clinical investigation medical university in the United States. We have over 65 various clinical trials that are ongoing at MUSC and the Charleston VA right now. For example, we have new medications for the treatment of heart failure that involve different approaches, proven quality of life as well as length of life. Besides heart failure, we have treatments for acute coronary syndrome, which is our term for heart attacks. As you can imagine, this is a potentially devastating disease and one has to diagnose and treat rapidly. We have new blood thinners, new stents, new agents that are being actively investigated.
Keep in mind, Pam, as we have been talking, all of these types of investigations involve, as a baseline, the patient receiving the standard of care, the best that is known, for him or her. Then, they are approached about whether they want something extra, something new. Potential benefits and risks are made aware to them, and many patients want to participate in these types of opportunities. At MUSC, other areas are being looked at. We have a very nationally preeminent electrophysiologic division. These are people who study the heart beat, arrhythmias, which is a major cause of people passing out and even sudden death in our society. We have leading edge devices and medications for this. And, as we know, MUSC is one of the leading heart transplant centers in the United States, or the world for that matter. Part of this has been the participation by our physician colleagues as well as patients in cutting edge trials to prevent rejection of heart transplants and to make donor organs last for as long as possible. These and other areas are being actively investigated at MUSC and we are actually expanding our program.
Dr. Pam Morris: Well, Dr. O’Brien, thank you so much for being here today and talking with us about this exciting area. I encourage our listeners, if you are interested in participating in a clinical trial, please visit www.muschealth.com. Thank you so much.
If you have any questions about the services or programs offered at the Medical University of South Carolina or if you would like to schedule an appointment with one of our physicians, please call MUSC Health Connection: (843) 792-1414.