Clinical Trials: An Overview Explaining Clinical Trials
Guest: Rebekah Whichard – Digestive Disease
Host: Dr. Linda Austin – Psychiatry
Dr. Linda Austin: I am Dr. Linda Austin. I am interviewing Rebekah Whichard who is a clinical trial coordinator with the Digestive Disease Center at MUSC. Ms. Whichard, people may not know exactly what a clinical trial is, just what is that?
Rebekah Whichard: They are health-related research studies that we conduct, usually, in patients. We use them to determine if medications and/or treatment options, new devices are safe and effective. They also evaluate the benefits and risks of treatments for patients.
Dr. Linda Austin: So, for example, if there is a new medication that is an experimental medication, it has to first go through the clinical trial process, is that right?
Rebekah Whichard: That is correct. It usually takes upwards of 10 years plus to get a medication approved by the FDA for use in humans. They start off with animal trials, and then we move them into healthy volunteers. After that, we go into further phases of studies in which we actually put them in patients that have a specific disease. Then, again, after 10 years of testing a medication, usually the FDA will look at all the data that they have collected and get it approved, by the FDA, if they think it is safe and effective for patients.
Dr. Linda Austin: So, let’s say, for medication, what are some of the sorts of questions that clinical trials might be designed to answer?
Rebekah Whichard: Well, first they want to know, what is a safe dose for a patient to take without causing any very harmful side effects? That is very important. After that, they want to know, what kinds of side effects the patient experiences while taking the medication.
Dr. Linda Austin: So, for example, they might try a given medication in a clinical trial at different dosages with different patients and then follow to see which dose is most effective?
Rebekah Whichard: Yes. Normally they do the dose ranging trials first, put those in healthy volunteers. After that, when they move them into patients that actually have a specific disease, they sometimes will test out different dosages. They pretty much at that point have determined what the safest dose is for a patient. But, they still may try different dosages in those trials to see if one dose works better in controlling a disease than another dose.
Dr. Linda Austin: So, in other words, this is the scientific process as pursued with real patients in real medical centers with real doctors to see what is really safe and effective medical practice?
Rebekah Whichard: Yes.
Dr. Linda Austin: Now, from a patient’s point of view, why would it benefit a particular individual to participate in a clinical trial?
Rebekah Whichard: Well, clinical trials are basically the future of medicine. The medications that we are researching now are going to be the future medications that are going to help diagnose and treat specific diseases. As we are all very well aware, patients use a lot of antibiotics, and they have to continually come up with new antibiotics. You have to research these antibiotics to find out whether or not they will be beneficial in treating specific diseases.
Dr. Linda Austin: So, from a patient’s point of view, one advantage, then, is that you are on the leading edge, you are getting medications that otherwise might not be available to you for 5 or 10 years?
Rebekah Whichard: Yes, that is true. It is very important. A lot of patients with specific diseases or conditions have exhausted all means of treatment options and these are the new, leading edge, therapies that potentially could be beneficial for the patient.
Dr. Linda Austin: I have done clinical trials in psychiatry and I have had the opportunity to use medications and see astounding responses in patients who have responded to nothing else, so that is a really important piece of it. What are some other benefits for a patient in participating?
Rebekah Whichard: We monitor patients in clinical trials very closely. There are normally a number of visits in which patients are getting blood work or different examinations, EKGs. Depending on the study, they get a lot of extra attention on their healthcare.
Dr. Linda Austin: They are scrutinized very closely and followed very closely, is that right?
Rebekah Whichard: Yes.
Dr. Linda Austin: So, they really get top-of-the-line medical treatment, with brand new medications. Now, how about the downside of participating in a clinical trial, what are some of the concerns that patients express?
Rebekah Whichard: Many trials today are placebo control studies which means that patients may receive an inactive substance versus an actual study medication.
Dr. Linda Austin: However, usually in those trials, do they, then, after that period of time, get the active medication following a placebo phase?
Rebekah Whichard: It depends on the trial. Some do allow for patients to receive open label medication after a certain period of time, some do not. It depends on the phase of the study and what the study is looking at as well as the medication.
Dr. Linda Austin: What are the safeguards to protect patients’ rights to have some oversight about their medical treatment, to protect their confidentiality?
Rebekah Whichard: Patients that participate in clinical trials are required to sign a separate HIPAA form. The HIPAA form allows us to give their personal health information or speak about their personal health information to the research team. We cannot share or collect any personal health information unless the patient signs a
HIPAA form. We do send out results, or data, from the studies to sponsors of clinical trials so they can formulate their results. When we send that information out to sponsors, we do assign the patients unique identification numbers as well as use their initials. The sponsor usually does not see the patient’s actual personal or private information.
Dr. Linda Austin: And, of course, before any of that happens, the trial itself has been reviewed by the Institutional Review Board, correct?
Rebekah Whichard: Yes, it is scrutinized by the IRB to make sure that the clinical research we are conducting is safe for the patients. They do understand the information that we are collecting and why we are sending it off, and what information we are sending off.
Dr. Linda Austin: So, there is oversight by this board that consists of clinical people as well as people from the community, often physicians or housewives, or attorneys or ministers or whomever might be interested in the ethical issues around research?
Rebekah Whichard: Yes, IRB is made up of several people with different backgrounds.
Dr. Linda Austin: Rebekah, thanks so much for talking with us today.
Rebekah Whichard: Thank you.
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