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Clinical Trial Phases Explained

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Published on September 19, 2019

What happens in different phases of clinical trials? Clinical research coordinator Jeanne Schaffer, from the Willamette Valley Cancer Institute and Research Center, explains the purpose of Phase I, II and III of the trial process. Jeanne also discusses ways patients are protected while participating in a study. Watch now to learn more about clinical trial phases. 

This town meeting is sponsored by Pharmacyclics LLC and Janssen Biotech, Inc. It is produced by Patient Power in partnership with The CLL Global Research Foundation, The US Oncology Network, Compass Oncology, Willamette Valley Cancer Institute and Research Center, and The Leukemia & Lymphoma Society (LLS).

Featuring

What a wonderful time we had! We were excited like fans at a rock concert, but our rock stars were the medical experts.

— Lynn, CLL town meeting attendee

Partners

CLL Global Research Foundation Compass Oncology The Leukemia & Lymphoma Society (LLS) The US Oncology Network Willamette Valley Cancer Institute and Research Center

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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.

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:          

I want you to meet Jeanne Schaffer, who’s been devoted to being a nurse in oncology for 30 years, Jeanne? 

Jeanne Schaffer:         

Yes, I graduated in 1984 and I’ve done oncology most of that time. 

Andrew Schorr:          

Okay. And she works as a clinical trial research nurse with this man, who’s doing a lot of research you heard about in the B-cell malignancies, lymphomas and CLL. So, we’re gonna talk about clinical trials. So, I was in a Phase II clinical trial. Dr. Choi alluded to even a Phase I and then a Phase II trial. So, first of all, just so we understand the basics, what’s Phase I? What’s Phase II? What’s Phase III? 

Jeanne Schaffer:         

So, in Phase I, they’re really just trying to find safety, a dose for the drug. Their population of a clinical trial for patients very small is not hundreds of people. It’s starting usually with three and then three more. So, maybe you’ll have like 50 people in a Phase I. 

Then they go on to a Phase II, where they see, “If we add more people, are we gonna get the same response that we’re getting?” They look more at efficacy. Maybe they try it in different cancers even, like maybe they start with anybody and then they narrow it down some. 

Then when they get to Phase III, they’re looking at more head to head comparing, “What are we doing now? With this new study, is it going to meet or beat what we have?” It already works for patients. It’s already approved. 

Andrew Schorr:          

Protections for people in clinical trials? I remember there was a Time Magazine cover many years ago that had a guinea pig. 

Jeanne Schaffer:         

Yes. 

 

Andrew Schorr:          

Are we gonna be experimented on? We want to get, maybe, tomorrow’s medicine today, but we don’t want to be put at risk. So, talk about that. 

Jeanne Schaffer:         

Yeah. A lot of people use the term guinea pig and a lot of research nurses don’t like that term, because possibly in the past, people were guinea pigs. But a lot of laws and things have come into place where people aren’t guinea pigs anymore. People have to be very well-informed. 

Studies are highly regulated. FDA is involved. There are very strict rules of what we do. If there’s a change in side effect, we have to let everybody know there’s been a new side effect identified. We are really looking at the safety of the patient, the patient comes first. 

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.