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The ABCs of Clinical Trials With Michele Nadeem-Baker, CLL Patient Advocate

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Published on April 30, 2019

Although some think they will be a guinea pig, patient reporter Michele Nadeem-Baker, a current participant on a Phase II clinical trial says, “I’m getting tomorrow’s treatment today.” What is clinical trial care really like? Watch now to hear Michele talk finding a good trial match and patient safety.


Transcript | The ABCs of Clinical Trials With Michele Nadeem-Baker, CLL Patient Advocate

Good afternoon. This is Michele Nadeem-Baker, your patient reporter for Patient Power, and today we're talking about clinical trials. How do you know if you should go on one, and, for that matter, are they safe?  A lot of people think that they're a guinea pig when they go on a clinical trial, but personally speaking, I am currently on one.  I am on a Phase II clinical trial, which I'll explain in a few minutes, but I'm getting tomorrow's treatment today.  That's how I do it.  Everyone is different in how they look at that, and everyone is different whether they're eligible for a clinical trial.  

So let me just explain a little for you, kind of the ABCs of clinical trials for the lay person. These are all the things that are public information on the web, but I'm going to bring it to you here.  I am not a doctor.  I do not try to be a doctor.  I am just here to advise you based on my experience as a patient and bring it to you here on Patient Power.  

So first of all, a clinical trial is a research trial, which you probably all know, where there are a number of people in the different phases of a clinical trial to see if they are safe for patients.  They collect all the data from patients on a clinical trial, and that determines if they are or are not going forward with presenting it to the Food and Drug Administration, the FDA, for approval.  And then it either gets approved or it does not braced on the research of the scientific studies and if there's a need for it.  

So, as an example, I am on a Phase II clinical trial, which I have said.  There are different phases.  There's phase 0.  This is just a concept of a trial.  There's Phase I, II and III, and then generally they go for approval.  The reason you would want to get in a later stage clinical trial is things have been tested a little longer.  Phase II, generally, they've seen that there is efficacy, that there is some safety going on because people have made it or not. Depending on the results from Phase I depends on if it goes to Phase II.  The same with Phase III.  

So the trial that I'm on I am part of the first cohort.  There are certain numbers of people on each part of the clinical trial. But instead of getting into that you're probably wondering, well, do I even want to get on a clinical trial. That decision is up to you and your oncologist.  You may not be the right—you may not have the right criteria for a clinical trial for what you have.  

I would first suggest that you ask your oncologist if you are curious about clinical trials if there are any Phase II or Phase III clinical trials that they know of for you.  You're going to get tomorrow's treatment today, especially if it's a later stage clinical trial.  Now, they may have clinical trials where you go at your cancer center, or you may have to go elsewhere.  And then the other option is sometimes even if you're going to a community doctor sometimes they will administer the parameters around a clinical trial close to you.  That's something again you need to speak to your oncologist about.  

But first you're going to ask, am I eligible for a clinical trial?  And if so, what is that?  And then ask for information, or you can go on the web to research it. Number two, always make sure that you're researching things on your own as well and see what is going on with that clinical trial.  Now, again, criteria for a clinical trial if you're frontline treatment, you've never been treated before, there are certain clinical trials for that.  If you are a relapsed patient there are also certain clinical trials for relapsed patients.  

And then there are even those that have other parameters, like your age.  I'm in a clinical trial for young people.  My favorite thing about this part is that it considers that I'm young.  That's great. Young and in shape, fit, healthy, other than having of course cancer.  

So you need to make sure you don't have any co?morbidities.  That's another thing that potentially there's a clinical trial that specifies your co?morbidity or some that do not.  I'm seeing that we're having some questions come in already.  I would love to answer your questions as I go forward.  

Now, the other thing you need to do is just every time you go to your oncologist I suggest you tell them, I am interested in a clinical trial.  I did that for quite a while with my oncologist, but with my type of cancer there's something called watch and wait.  You don't go immediately into treatment, which is counterintuitive. But just whenever you meet with your oncologist, if you're interested in a clinical trial, if you've done your own research online, just ensure that you tell them, I am interested in a clinical trial, because not everyone is.  

The other thing you have to know is that you will get incredible care on a clinical trial and that you are being watched very closely.  You will be in closer touch with your oncology team.  They will be doing all the tests possible.  They will be ensuring that you're doing well because they want to ensure that their clinical trial is a success with you.  

Where can you go then to find out about clinical trials?  The National Institutes of Health, NIH, has something called where you can go, and you can research.  You put in what you have, and if you're a caregiver you can do this with a person that you're researching information for, put in what they have, and then it will spout out all the different trials there are.  Look up what there is.  See if they're still open, if they are still accepting patients in the clinical trial.  See what the deadline is.  See what the parameters are.  I suggest you look into this and then bring this to your doctor to your next oncology appointment and discuss it with them.  

You'll have to take other things into consideration such as where the trial is, if there are any trials near you, right, your cancer center, and again is where you want to go to look up the different trials that are happening out there.  

You know, I just heard a doctor speaking today earlier on a teleconference regarding different patients and about cancer itself, and there is considerable revolutions going on right now in treatment.  There are so many things in treatment—in research right now for cancer treatments that it's considered that there's a revolution going on in oncology. There's never a good time for any of us to receive that diagnosis that we have cancer, but there are so many different drugs in discovery, combination therapies.   

There are all kinds of things that are in trial right now, such as chemotherapy, which is for some diseases becoming more old-fashioned, may not be here in a few years because there are so many other kinds of treatment.  There's immunotherapy, also known as immuno-oncology.  There's combination therapies using a few different single-agent drugs or also using antibody drugs and single-agent treatments. There's all different combinations of these.  And there's also stem cell transplants, which we've seen, and CAR-T, and heaven knows when the future is going to be bringing us for clinical trials and the future of treatment for cancer patients.  

There are also some myths out there.  I suggest you look at the Patient Power MythBusters videos regarding myths and clinical trials. A lot of people think that on a clinical trial there's always going to be a placebo group on it.  That is not necessarily true, and there are hardly any trials that do that any longer, but always ask.  It does not hurt to ask.  If you go on a trial and sure there's no placebo group on that, and generally there are not any more, you just want to make sure that you're safe, that your oncologist and you are on board both for doing this and that you get the best care that you can today so that you'll still be with us here tomorrow. 

So if you have any questions please comment in.  There's so much information about clinical trials to share, and there's a lot of it online, here on Patient Power as well as on your particular cancer association site, such as the lymphoma—Leukemia & Lymphoma Society, the Lymphoma Association, the American Cancer Society, and the Lung Association.  So I look forward to seeing you on my next broadcast, and until then check out  

Take care. This is Michele Nadeem-Baker for Patient Power.  

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you.

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