Clinical Trials 101

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Topics include: Treatment | General and Understanding

Clinical trial participation is an important and personal decision, and patients may want to understand more before getting involved. Watch now to hear Dr. Amit Verma, from Montefiore Medical Center, cover the basics of clinical trials, including the different types and phases. He also discusses how AML patients are protected and when they should consider participating.

This was a Patient Empowerment Network program produced by Patient Power, in partnership with The Leukemia & Lymphoma Society (LLS). We thank Astellas, Celgene Corporation, Novartis, Pfizer and Seattle Genetics for their support.

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Transcript

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. 

Andrew Schorr:

So help us understand, if somebody's in a trial and let's say I think you call it two arms of a trial, somebody's getting the experimental drug, somebody isn't, maybe in combination, how does that work so they feel protected no matter what, Dr. Verma? 

Dr. Verma:

That's a great question, Andrew.  You know, there are two types of trials.  There are trials that are early stage.  They are usually called Phase I or Phase II, and then there are trials specifically like the one you mentioned which are called Phase III trials.  Phase III trials have two arms.  So a patient can go into either arm, and it's usually a decision which is made randomly.  One of the arms is an experimental arm, and one of the arms is a standard arm, meaning that it's a therapy that's approved by the FDA and that's used in standard treatment of that particular disease. 

In the experimental arm also, you know, we have—every time there's a trial that's written it has to go through an exhaustive review process, multiple rounds of review where physicians and scientists made the determination that, number one, this is not something that will do harm to the patients, and number two if this is scientifically and medically justified do we test it.  So if a trial is being offered to a patient, that means that it's already passed that review by other oncologists and doctors and as well as scientists.  

Number two, when you're being approached with a trial, usually it's in a situation where the standard treatment is not going to be curative.  This is offered in a situation where your physician feels that just by going what's approved, what's standard you're not getting the best possible chance for a cure. 

And in that situation if you have any doubts as a patient, I would encourage patients to ask as many questions as possible.  You know, a good hematologist or oncologist will take time to answer your questions no matter how many they are.  And especially if it's a clinical trial, you know, it is the job of the hematologist to tell you slowly and with as many details as possible what is the rationale, why they want to do this, you know, what is the likely outcome, and more importantly what are the all the side effects that can happen with that experimental agent.  

And the aim is not for the patient to feel like they're just being used as an experiment.  The intention here is to improve your care, to improve your chances of cure and secondarily, also acquire information which will help other patients down the road.

Because unfortunately these diseases are still not the ones that we can cure very well, and we're always looking to improve our cure rates.  And, you know, let's say we treat a patient on a trial and it does really well, it will help get it approved for other patients.  On the other hand, unfortunately, the trial does not work.  Then we will know that this drug combination maybe doesn't do as well, and that will also help other patients.  But that's the secondary objective.  The first objective is to give the best possible chances for remission or cure to an individual patient. 

But it can be overwhelming.  You know, you're hit with this diagnosis.  You suddenly start learning terms that you never heard of.  There are many types of leukemia, add these 20 different types of mutations on top of it, you know, your mind freezes.  And then you have somebody tell you that, look, we're going to treat you with an experimental therapy.  You know, that's icing on the cake.  So I think the important thing is you take time, you talk it over with your friends and family, and then bring them also.  If they have questions—you know, we frequently talk to patients' relatives on the phone, and I think it takes time.  It's not an instant decision.  No patient will ever make instant decisions—some do, but most don't—that will put them in a reassured state of mind.  So it takes time, and you should find a hematologist that sits patiently with you and answers your questions.                  

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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Page last updated on March 9, 2018