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Randomization in Clinical Trials: An Expert Explains Patient Equality

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Published on August 14, 2018

Patient advocate Jim Omel tackles the hot-button issue of randomization in clinical trials. How are treatments allocated amongst patients? Watch now to hear Jim define the key terms randomization and equipoise as they relate to clinical trials and explain how treatments are balanced between arms. What determines patient equality? Jim also gives a patient perspective on participating in a trial with the chance of receiving standard therapy or an innovate treatment.

This is a Patient Empowerment Network program produced by Patient Power. We thank AbbVie, Inc., Astellas, Celgene Corporation and Novartis for their support.

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Transcript | Randomization in Clinical Trials: An Expert Explains Patient Equality

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.

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 first of all, we mentioned this term "randomization."  So people wonder in cancer am I going to get the good stuff? I know that I'm sick, maybe like in your area, multiple myeloma, there have been lots of new medicines, but in some other areas not, like pancreatic cancer, for example. 

So, say, I understand the standard therapy and you're testing it maybe against that, but I want to get the good stuff because I'm really hopeful.  I want to be a believer.  So could you just describe where we are with randomization, because that's a concern people have. 

Dr. Omel:

Absolutely, Andrew, and thanks for asking that question.  That's a real red, red hot-button item for me.  I maintain that if the patient has gone through the effort of studying their cancer, studying the possible treatments, and they've learned of a trial that's opened that they would qualify for, they're excited, they go talk to the principal investigator, and they say I want to be in this trial.  And the PI turns to them and they say, well, we'll flip a coin.  You may get the medicine we're going to be using, or you may get standard therapy.  Just imagine how disappointing that would be. 

And when it comes to randomization, Andrew, there's many, there are many trials that absolutely lack equipoise.  And I'm afraid that scientists often use equipoise. 

Andrew Schorr:

Now, tell us what that means.  You've got to define that for us. 

Dr. Omel:

Equipoise basically means equal, equal balance within the arms.  In other words, technically, officially the principal investigator doesn't know which arm is best.  And yet look at it from the patient's standpoint. 

Let me give you an example.  There was a trial in which patients had the choice of three oral drugs in one arm versus a stem cell transplant in another arm.  Now, think about that.  Think of the insurance ramifications.  Think of the fact that it takes almost a year to really totally recover from a stem cell transplant, versus taking three oral drugs.  How can anyone say that there's equipoise in a trial like that?  So how can you pattern your life with the flip of the coin or a computer randomizing you into one of those arms? 

Andrew Schorr:

Wow.  That's, that's an important issue.

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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