Are Clinical Trials Safe? Experts Allay Your Fears

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Are clinical trials safe? Why should you consider participating in one? Experts from MD Anderson Cancer Center and the Stanford Cancer Institute discuss what clinical trials are, how patients are monitored, and why these trials are so important in the fight against cancer. If you have ever considered joining a clinical trial, this is information you will want to hear.

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Please remember the opinions expressed on Patient Power are not necessarily the views of MD Anderson Cancer Center, its medical staff 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.

Jeff Folloder:

And from the standpoint of social work, and the physician’s assistant, I know that a lot of us, when we hear the words clinical trial, there [are] two more words that show up in our brain, and those words would be guinea pig. Fair enough? How do you address those concerns with patients?

I mean, we’ve got doctors who are obviously saying this could give you the best possible benefits and all the patient is hearing, but the downside is, dot, dot, dot. How do the two of you deal with that particular issue? Clinical trials are important. How do we get more people on board?

Lindsey Lyle:

Well, I think it’s important to understand what a clinical trial is, and there are different phases of clinical trials, like we’ve discussed earlier. And I think that this comes up quite a bit. Patients say, Lindsey, I’m just going to be a guinea pig. We don’t know what this does.

And I think the most important thing is to tell the patients, number one, you’re not a guinea pig. You know, we do not treat our patients like animals. We treat our patients like human beings. And our number one goal is to affect your life for the better.

So we would not enroll a patient on a clinical trial if we did not think that there was an opportunity for a benefit. And I think that’s the first thing that the patient needs to realize. Alternatively, I think that they also need to understand that these medications have been studied in a variety of different settings.

And they have proven safe. Some of them are in early stages of development, but we go over risks of the possible complications. And as long as the patient is well educated on possible risks that we’ve seen when studying this medication prior to them starting it, that will be very helpful.

The other thing is that, in patients on clinical trial, they’re very closely monitored. You know, they, at MD Anderson, they have a research nurse who becomes, like, number one on their speed dial and, you know, is ready to answer any questions at all hours of the day. And they forward them on to Dr. Verstovsek or myself. And, you know, this is really good for the patient, because they’re keeping really close monitoring of their symptoms or possible side effects, because we are trying to figure out if this medication could also benefit other people.

The point of the clinical trial is to help you first and foremost but also to possibly help patients in the future should it show to be beneficial. So I think that, understanding really what that means is an important piece.

Dr. Verstovsek:

A couple of, just comments here. It’s safety first, right? A study is a study. A person is a person. The person is first, the safety of the person is first. We hope for the benefit. We propose a study, and we educate everybody and the patient to participate if he or she is willing to understanding the risk and benefits.

And if there is a really good reason to participate, which is discussed, then we would monitor the patients in the study and make sure it’s first, safe and hope that it’s much better than what the standard of care would be. The second is, it’s not a contract.

The patient has to sign a consent form, and the doctor signs a consent form. The patient is willing to participate. The doctor is responsible and judges, in his medical opinion, that the patient is a candidate for the study. Tomorrow, the patient says, well, I don’t want to do it. It’s okay. That’s okay. That’s perfectly fine.

There is always alternative, and it’s not ever only one choice and you have to do it or you don’t, and then we won’t see you again. There is always alternative and there will be, always something else, and perhaps we will work out even better for the patient.

So it’s something that we go through together with understanding and the collaboration. Again, I always emphasize this, the team effort together, and the patient is leading the charge.

Dr. Gotlib:

And I would just say that the term guinea pig, I think, reflects the burden of history and reflects 50, 40 years ago when there weren’t as many regulations, where there were practices that were abhorrent. And I think that you’ve got a system in place led by the FDA and multiple layers, institutional layers, federal layers.

You’ve got investigators that have to go through very formal training to ensure that the patient safety is first and foremost, that there’s informed consent, that we stick to the mandate to do no harm. You know, we have to realize that there are some trials that are first in human that they’re studied in mice. 

And, you know, when we see side effects in mice or no side effects in mice, we can’t always, of course, anticipate what’s going to happen in humans. But if we go through the process of enrolling patients appropriately, making sure that they’re an active participant in the trial process, and we monitor very carefully, this is where minimize harm, and hopefully we get an active signal that the drug is also effective.

Please remember the opinions expressed on Patient Power are not necessarily the views of MD Anderson Cancer Center, its medical staff 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 April 3, 2017