Clinical Trials: What a Patient Should Expect
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 one of the clinical trial coordinators at the Digestive Disease Center (DDC) here at the MUSC. Rebekah, let’s walk through the process of a patient who is interested in participating in a clinical trial. Let’s imagine they have a digestive disease, such as ulcerative colitis or Crohn’s disease, or irritable bowel syndrome, one of those. What would be the first thing that they would do?
Rebekah Whichard: After contacting us and determining that they are potentially eligible for the study, we bring the patients in and conduct a screening visit. We usually run a battery of tests and perform physical exams. The results of those tests will tell us if a patient is eligible for a clinical trial. If they are eligible from that point, we get them enrolled and randomized to either study drug or placebo, depending on the study. Some studies just have study drug.
Dr. Linda Austin: Now, let’s back up before we go on though. Would you have first talked with the primary care provider? What would be the role of that person in this?
Rebekah Whichard: It depends on the patients. Some patients that are our [MUSC] patients are automatically seen by our physicians. They are referred over by our primary care physicians. Patients that are not patients of MUSC are usually referred over to us by their physicians for continued care, sometimes just for clinical trials.
Dr. Linda Austin: So, then, one of the doctors at the DDC would do a very thorough physical exam and whatever studies and tests are necessary to make sure what the diagnosis is? So, it starts there with a really thorough diagnostic evaluation?
Rebekah Whichard: We review the patient’s records as well as have the physicians evaluate the patient, to verify the diagnosis.
Dr. Linda Austin: How do you explain the clinical trial to the patient? Or, let’s imagine that they have an illness and there are several clinical trials. I know medical language can be kind of overwhelming if you are not used to it. How do you get around that issue so people really understand what they are getting themselves into?
Rebekah Whichard: We review the informed consent document which goes into great detail about the study as well as what is expected of the study, the study visits, what the patient is expected to complete in the trial. This consent is reviewed by our institutional review board, making sure that we do not have too deep or too much medical language in there. We try to keep it at a simple level for most patients so we do not overwhelm them with too much information.
Dr. Linda Austin: So, it is vitally important that the person truly understands what the clinical trial is, truly understands what the words mean, what the medications are, what the possible benefits are, what the possible risks are, what there rights are, all those sorts of things. Now, you mentioned the word randomized. What does that mean?
Rebekah Whichard: When we randomize a subject, normally a computer or some other means will assign the subject to a study drug, to a specific dose of study drug or a placebo, if the trial is a placebo-controlled study.
Dr. Linda Austin: So, in other words, any clinical trial, or most clinical trials at this level are comparing different groups of patients, different dosages of a medication, or comparing a placebo or a non-active substance with a medication. Is that right? And the randomization assigns the patient to a particular group?
Rebekah Whichard: That is correct. Most clinical trials that we conduct, depending on the phase that they are in, are randomized trials.
Dr. Linda Austin: What happens after that? Let’s say the patient qualifies. Let’s say they understand the informed consent. They sign the documents. They are told, okay, you are going to be in Group A, or Group B, what happens next?
Rebekah Whichard: Once a subject is enrolled into the study, we watch them very closely. We want to make sure that they are safe during their participation in the study, that they do not experience any adverse reactions to the medication. So, they usually are asked to come into the clinic several times, it may be every couple of days, it may be every couple of weeks, it may be once a month, for us to evaluate the patient as well as administer study medication. That will go on until the study comes to completion. Or, if the patient does experience something out of the ordinary, medically speaking, we ask that we call us and we will bring them in to be seen immediately.
Dr. Linda Austin: So, you are rating the patient’s symptoms periodically, you are asking them about side effects, you are asking them about their experience to try to get a feeling for whether the medication is working or not and what are the side effects, and so forth?
Rebekah Whichard: That is correct. That is vital data that we collect to send to the sponsor which is shown to the FDA for final FDA approval of a medication.
Dr. Linda Austin: So, then, at the end of the study, does the patient get to find out if they were on placebo or real medication?
Rebekah Whichard: They do. Usually, it could be upwards of a year or two for the clinical trial to be unblinded. When we find out that information, we do notify the subject if they received study drug or placebo.
Dr. Linda Austin: And, if the medication worked, does the patient get to stay on that medication even when the study is over?
Rebekah Whichard: Some sponsors have open-label trials which the patient can roll over into after completing the first phases, which are usually placebo-controlled. So, usually after a certain amount of time, if the patient responds, or does not respond, they do have the option of going into an open-label study in which they will receive medication for a specified amount of time, usually until FDA approval.
Dr. Linda Austin: Rebekah, thanks so much for talking with us today.
Rebekah Whichard: Thank you.
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