Addressing a History of Fears About Clinical Trials: An Expert Weighs In

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Andrew Schorr:

Dr. Schilsky, let's talk about another reality of trials.  There's a history certainly and some fear still in the black community of whether they were tested on, without their knowledge even, going back years and the general thought, you've heard it through your career, I'm sure, people say, well, I don't want to be a guinea pig for a couple reasons.  One is we don't know if it's going to work.  And second of all if there are different arms of a trial I don't know if I'm going—I'm going to go to all this trouble and expense, I don't know if I'm going to get the good stuff.  So maybe you could speak about that a little bit.  First of all, the fears of being experimented on, and then also about whether you will get what could be a breakthrough. 

Dr. Schilsky:

Yeah.  Well, for sure, you know, there is this sort of sordid history of inappropriate experimentation on people, and clinical trials are a form of experimentation.  They are a form of research.  There's no doubt about that.  But clinical trials these days are highly regulated, overseen by independent groups that include patients and clinical experts that come together in committees called IRBs, Institutional Review Boards, and they evaluate on both the risks and the benefits to patients who participate in clinical trials. 

They make sure that the trial has an appropriate consent process associated with it, that it's explained in plain language to patients, so I think these days a lot of those concerns no longer exist.  And I hope that people can get beyond the history that led to some of those concerns. 

One point I want to make clearly is that in most cases cancer clinical trials do not include a placebo or an inactive treatment.  That's not always the case, but it's true most of the time.  So patients are always going to get at least the standard of care treatment, and of course the standard of care is what is at that time known to be the best available treatment. 

The whole point of doing the research is to determine if the new thing is better, and of course we always hope it will be.  It's not always better, but sometimes it is, as in Mel's experience.  And I think this has to be clearly laid out to patients.  They have to clearly understand why the research is being done.  In many trials nowadays even if the patient is assigned to get the standard of care treatment there still may be an option to get the new treatment at a later point.  So if the standard of care doesn't work many times there's still the opportunity to get the new treatment following the standard of care treatment. 

So the trial really boils down to not standard versus new but new versus standard followed by new.  So eventually everybody may have a chance to get the new treatment.  That's not always the case, but I think the key—my key take-home, in a sense, is that we're doing the research because we think and we hope the new treatment is better, but we have to do the research to prove that.  And everybody in a clinical trial I think can be assured that they're going to get, at the very least, the best available standard treatment. 

Andrew Schorr:

Mel, when you signed the papers to be in a trial, and you probably shared them with Cecelia, especially back in the late '90s and I participated in one trial in 2000 and another in 2011, there's a lot of paperwork, things in bold face written by lawyers.  I didn't always understand it.  What propelled you beyond that?  Was it just that, oh, my god, if I don't get something I'm going to die?  Or how did you two deal with the paperwork and feel comfortable signing on the dotted line? 

Mel Mann:

Well, I saw a lot of hope in the paperwork.  For example, one trial I was on was peginterferon, and I had been taking interferon every day, injecting myself, and I had to keep it refrigerated and when I travelled it made it difficult.  So with peg I can take one shot a week, so that would make the cancer journey easier.  It may not make me live longer, but it will improve my quality of life, so I saw my quality of life improving with that clinical trial.  And I looked at the paperwork, and I went through it, and I felt comfortable with it. 

Andrew Schorr:

And how about you, Cecelia?  I mean, your husband says, well, I'm going to be in a trial and I've got to sign all these papers.  Did you say at any point, wait a minute, that's scary?  

Cecelia Mann:

Well, no, I didn't.  I didn't because with Mel, he had three years to find a marrow match, and he was at the end of year two and no match in sight.  And so when he had the opportunity to go out to MD Anderson and be on a clinical trial or several, I was okay with that.  I was okay with that.  And I looked at it as actually being a blessing.  And it turned out to be, and we're grateful. 

But I would say to anyone else who is contemplating a trial and that person and their caregiver, their spouse, to just educate yourself, and get as much information as you can, ask as many questions as you can, but please don't just throw it away out of hand.  It's definitely worth considering.

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.