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What Factors Could Exclude Me From a Clinical Trial?

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Published on January 23, 2018

Is a patient still eligible for a CLL clinical trial after undergoing CLL treatment? Our panel of experts—Dr. Michael Keating from MD Anderson Cancer Center, Dr. Jeff Sharman from The US Oncology Network and Dr. Stephen Spurgeon from OHSU Knight Cancer Institute, discuss the inclusion and exclusion criteria for clinical trials. Tune in to learn more about participating in the future of CLL treatments.

Provided by CLL Global Research Foundation, which received support from AbbVie Inc., Gilead Sciences, TG Therapeutics, Pharmacyclics LLC and Janssen Biotech, Inc., and Genentech. Produced by Patient Power in collaboration with The US Oncology Network, Compass Oncology, and Willamette Valley Cancer Institute and Research Center.


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


CLL Global Research Foundation Compass Oncology The US Oncology Network Willamette Valley Cancer Institute and Research Center

Transcript | What Factors Could Exclude Me From a Clinical Trial?

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. 


My question has to do with talking today, we’ve heard a lot and been interesting about these proteins can be intercepted at different places. I’ve been in a number of clinical trials. I like clinical trials. Unfortunately, now I’m finding out that because I’ve had a BTK inhibitor, for example, I’m now prohibited from being in other BTK trials. I wonder if, do you see that’s gonna change at some point? Talk about people who relapse. Well, is there gonna be a group of people who relapse from these new drugs? Is there gonna be a time when we’ll also be able to be in trials, even though we've had a previous version of these drugs?

Andrew Schorr:         

This deals with exclusionary criteria.


Right. Yeah. Exactly. Yes.

Andrew Schorr:         

Okay. Dr. Keating, do you want to mention anything about criteria for trials and the ability to go on? 

Dr. Keating:               

I think, unfortunately, if you look at the clinical trials, most of them are not developed by the investigator. Companies come and they say, would you like to participant in this clinical trial that we have designed? You have a list of about 17 inclusion criteria, and 17 exclusion criteria. Many of them, we don’t agree with. That’s the reality of the situation at the present time.

Whereas, in the past, the National Cancer Institute used to help us develop clinical trials that were investigator-initiated. We have very, very little say in modifying the protocols. There's this whole bureaucracy that, and need to employ people to check on eligibility. You get punished if someone couldn’t get a babysitter one day and has to come three days late. You get dinged for that.

Dr. Keating:               

One of the really bad exclusion criteria, I think, is that if patients have had another cancer in the past, they won't let you on the clinical trial. It seems absurd to me that if we’re dealing with treatment of a cancer, having had another cancer excludes you.

Andrew Schorr:         

Yeah. Like me with myelofibrosis at the same time as CLL.

Dr. Keating:               

So, that people that have had things that are not necessarily going to require therapy for some years will be excluded from the trial. Thanks for your—Dr. Spurgeon, do you have a comment?

Dr. Spurgeon:            

Just two comments. I think the other thing to recognize is there—although it’s more difficult to get funding for investigator-initiated trials, if you as an investigator, come up with your own trial, you often have much more control over what those inclusion criteria are.

One way to advocate is to also invest in investigator-initiated trials. Then, also we want to make sure the science makes sense. If someone fails a BTK inhibitor, for instance, and there's another BTK inhibitor that it has exactly the same properties as far as the binding site, well yeah, it doesn’t make sense to go on that other BTK inhibitor. 

Because they're just a modification of the same drug. Another thing I would say is that’s the important one. When we’re looking at you, or if I’m seeing you, and these people as well, we’re not just thinking about that treatment. We’re thinking about the next treatment and the one after that. That’s important to bring that up there. Say to your doctor, “So, I see you're recommending this treatment. What implications does that have for future treatments?”

Andrew Schorr:         

Right. A road map. I mean, it used to be in cancer, where you guys said, well, we need to beat the cancer back now. Years ago, we had people with breast cancer, whatever, and they'd have a lot of radiation, and maybe there was gonna be a complication later, but you wanted to save somebody’s life then. How do you think about it, Jeff, now, this road map? What Steve was just talking about. You need to, because we’re talking about a long-term illness.

Dr. Sharman:              

Right. It’s even harder to think about a long-term road map when the roads keep getting rearranged. We’re at this place where there's this acceleration of new therapeutics that are available. What’s relevant today might not be relevant several years down the road. I’ll take maybe a slightly contrarian view of the inclusion, exclusion criteria. I recognize that that can be a headache, at times, to be dealt with. When you're doing a clinical trial, you're seeking to measure something and understand the impact. 

Sometimes you do need a clean population with which to do that. So you look at something like the secondary cancers. Somebody who had a skin cancer five years ago, that might not be relevant. But, if somebody has an active lung cancer that might be the one that’s going to cause them to pass away, you can’t necessarily measure the impact of a new drug on their CLL if that’s not what’s gonna cause them to pass away.

I think there's a little bit of frustration of good intentions. I think that a lot of these make sense for why they're there on one level, but then can be frustrating. They don’t always make sense. There are some that really make you want to bang your head against the walls as an investigator. I think we’ve all encountered those.

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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