Understanding Clinical Trials: What Are the Phases?

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When should you consider clinical trial participation? What are the phases of clinical trials? Dr. Bart Scott from Seattle Cancer Alliance and Linda Seymour, a Hematology Clinical Trials Research Nurse at City of Hope, discuss patient participation in clinical trials and explain the phases of clinical trials and their purpose.

This event was produced in association with City of Hope and sponsored by Patient Empowerment Network through educational grants from Incyte Corporation and Geron Corporation.

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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:

When you discuss treatment, Dr. Scott, what part of the discussion, you’re both at research institutions, and we’re trying to move the ball forward in treatments for these illnesses, what part of the discussion is a clinical trial? Is that part of what’s on the table?

Dr. Scott:         

I think it should be part of what’s on the table for everyone. So even in patients who don’t need treatment, we have clinical trials, as you pointed out, to follow quality of life. And in patients who do need treatment, we have a variety of clinical trials that are available to patients.

That will usually test what’s currently considered to be the standard of care to what we think may be even better. So I think that clinical trials should be a part of the discussion in everyone, at any stage of disease.

Andrew Schorr:

Okay, Linda, help us understand clinical trials for a minute. So I was in a Phase II single center clinical trial originally, and then later, I was in a Phase III trial with the DVT and all that. So what are the different phases? What does it mean?

Linda Seymour:

Well, there are four phases in clinical trials, one through four. And in Phase I, the focus of the trial is the toxicity of the drug. So we would like the drug to help the patient, but that is not what the trial is focused on completely. We can’t guarantee that the trial drug will have any effect for the patient.

What we are looking at is what we call DLTs, or dose limiting toxicities. And the patient will start at a specific dose that we feel is safe enough for the patient. And depending upon how that goes and depending upon how the trial is formed, that dose can be increased or not increased.

But so, if the patient does well in the Phase I trial, that’s an extra bonus. But we’re also, again, looking at the toxicities of the drug, because we don’t want a lot of people developing severe toxicities. So Phase I is a very small group.

Andrew Schorr:

Phase II?

Linda Seymour:

Phase II is similar to Phase I, in that it’s still a small group of individuals who qualify for the trial. But we’ve expanded from the Phase I, to having more patients go on the trial. So that we’re continuing to find out what the dose limiting toxicity is, so we’ve increased the dose level.

And then hopefully again, that drug will be found to be helpful to the individual also.

Andrew Schorr:

Three?

Linda Seymour:

Phase III is that you are putting two different drugs against each other, to find out which drug, they’ve both shown efficacy in the disease that you’re looking at. But you’re seeing which drug will be more helpful for those patients. And… if Dr. Snyder or Dr. Scott, I don’t know if you have anything else to say with that.

Dr. Scott:

It’s not always that, sometimes the drug that is testing against may be a placebo. So that there’s no good treatment out there. Sometimes it will be tested against a placebo. That scares a lot of patients, I’m sure. It’s like, wait a minute. You’re going to randomize me to get no treatment, versus treatment. Can I please get the treatment?

But keep in mind, if we knew for a fact that this treatment was beneficial to you, we would not have a placebo control. It wouldn’t be ethical. These trials go through multiple reviews with institutional review boards, many different doctors. We serve on a lot of different committees. And part of our job is to review these studies, and make sure that they are ethical. So if we have a placebo control that means we don’t know for certain that the test drug is going to benefit you. So you shouldn’t be completely opposed to placebo control.

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 June 18, 2015