Published on September 14, 2018
Eligibility criteria determines who can and cannot participate in a clinical trial. Do today’s studies reflect the actual patient population? Why is inclusion so narrow in some cases? Watch now to hear from expert Dr. Mike Thompson, from Aurora Research Institute, and patient advocate Jim Omel as they dissect how clinical trial inclusion and exclusion criteria can become too restricting, patient access to clinical trial care and ways previous studies can influence current eligibility. The panel also discusses alternatives to clinical trial design and tailoring treatments to patients by using mutation analysis to match individuals to suitable trials.
This is a Patient Empowerment Network program produced by Patient Power. We thank AbbVie, Inc., Astellas, Celgene Corporation, and Novartis for their support.
Transcript | Evaluating Inclusion and Exclusion Criteria in Clinical Trials
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One way to get at this and another different take on it is inclusion and exclusion criteria. So this has to do with access and individualizing and being patient centric. Many of the inclusion and exclusion criteria, when somebody says, oh, I have lung cancer, oh, here's a lung cancer trial, and they say, oh, you can't go on the trial. And much of that is because there's language that's been cut and pasted from a previous trial which is not really pertinent.
So if the new drug is metabolized by the kidney you don't necessarily need to look at the liver studies. And we did a small study or I was aware of a small study done by Kaiser where if we improve the inclusion?exclusion criteria accrual rate can go up 30 percent. So no cost to that.
So first of all, we're in this age where electronic medical records, it would seem that at your fingertips there could be some analysis of your record and some matching or offering of trials that could come out of an analysis of your results, genomic results, do you have ALK or ROS or whatever, if it's lung cancer, whatever it may be, maybe JAK2 positive in myelofibrosis, what is various status for us.
And also broader inclusion criteria, and Mike was getting at that, saying some was just??excluding was just cut and pasted. And a lot of us patients would feel, well, that's just unfair. So what's your comment on all that, about inclusion and exclusion and analysis so we can be matched with trials more easily, can be offered to us?
Inclusion and exclusion criteria are really important parts of trials. They're what get people into trials, they're what keep people from being in trials. And, unfortunately, Andrew, many times the criteria are very defined, very narrowed, and drug companies especially want to do it this way to get the best effective appearance of their drug. They want to get approval. And yet in the real world, in fact most times, patients who would not even need inclusion criteria are the very patients that are going to be taking these drugs.
And Mike's right. There's too much cut and paste. If a trial takes a thousand patients to write a proposal or protocol, too many times researchers will just take the exclusion criteria that might have been from a previous trial and, like Mike said, cut and paste it when perhaps it's not even necessary to have creatinine values or kidney values measured so precisely on this particular drug compared to the other one.
So those are the criteria that let people in or keep people out of trials, and they absolutely need to be widened. To make a drug more applicable to the general population we need to reflect the general population more in trials.
Right. Right. It's sort of a Catch-22. So if somebody is at a drug company and they're investing hundreds of millions of dollars maybe to develop a drug, and then that trial is languishing or taking longer to get there, somebody ought to go back and say, well, can I loosen up this criteria, get the big answer and do benefit to patients who may be very willing to be into a trial that doesn't have all of these requirements that are not really necessary, and we get the answer and get it quicker, and help people along the way. I mean, it's pretty obvious to me, and I hope they're watching, folks.