How does M. D. Anderson protect patients?

From Patient Education
Date: Fall, 2007 Duration: 05:19

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(Music)

Narrator:
Patient safety is the major concern in all areas of research and is accomplished in several ways.

Dr. Maurie Markman:
It is something that we take so seriously here. We know that the most important thing is patient safety.

Dr. Richard Theriault:
…usually a clinical trial goes through multiple phases of vetting and approval, before it actually gets used. So the first step might be, ‘I have to present my trial to my department members, and they have to critique it and say it’s scientifically valid…we could do it with the population we have; you have experience,' and so on.

Narrator:
After several more levels of approval, the protocol then goes to one of M. D. Anderson’s Institutional Review Boards, or IRBs. An IRB is a committee of people, such as doctors, nurses, scientists, chaplains, social workers, attorneys and patients, who are responsible for protecting clinical trial participants and making sure that the trials follow federal laws.

Each trial has eligibility requirements that you must meet, before you can participate in that specific trial. These criteria might include information about age and gender, type and stage of the cancer, previous treatments you’ve had, results of certain laboratory tests, medicines you are taking or other medical conditions.

Dr. Maurie Markman:
One of the most difficult issues in terms of explaining to patients is that there may not be a clinical trial available for their condition, or there may be a clinical trial available for their condition, where they do not actually specifically meet what we term ‘eligibility.’

Dr. Shreyaskumar Patel:
There are other issues wherein the patient may come in with some limited information that might have led one to believe that this clinical trial would be appropriate, but when we actually see the patient, we may feel that a retrial of one of the older drugs at a higher dose may clearly be in the patient’s better interest, and so then even though they may technically be eligible for a clinical trial, we may recommend that there’s something else that may be more appropriate for you, because at that stage of the game, the primary driver of the clinical decision as to which treatment the patient goes on is the efficacy part – what’s going to help the patient the most.

Narrator:
If your doctor offers you the option to participate in a clinical trial, you will first take part in a process called informed consent. In this process you will learn about a specific clinical trial so that you may decide whether you want to participate. The informed consent process is designed to make sure patients understand the clinical trial’s plan before agreeing to participate. The researcher or nurse from the clinical trial team will review an informed consent document in detail with you to explain a specific clinical trial’s purpose, procedures, risks and benefits.

Dr. Richard Theriault:
That document is the framework for discussing with the patient or the subject participating in the research what you’re going to do.

Narrator:
Ask your research nurse if you need help understanding any of the information contained in the informed consent document. Interpreters are available if you need the informed consent document read in another language.

Robert Holman:
…if you find anything, that you don’t understand, get you a marker and mark that, and when you come back, they’ll answer the questions for you. And there are no stupid questions. There’re no dumb questions.

Sue Schwartz:
I read everything they put in front of me. I didn’t sign anything without reading it. But I was fully aware of what I was choosing to do.

Narrator:
Informed Consent does not end with the signing of the document. It is a continuing process. Patients participate in clinical trials strictly on a voluntary basis and can choose to stop their participation at any time.

Sue Schwartz:
. . . they came in, and they . . . all of the surgeons and the doctors and so forth . . . and they said, ‘here are some options'. This is the standard treatment. We know what this will do for you. Here is the protocol treatment. We know that it’ll do the same things for you, that the standard does, but it may also do some extra things, and you choose which you want to do.

Jesse Newman:
Once you start in a clinical trial, if you get a few months into it or halfway through it or whatever, and it becomes a burden to you, and you think, ‘well I’m just tired of doing this… it’s just not worth it…’ there’s clauses in the protocol that states that you can discontinue the trial any time you want to, no problem with getting out of the trial. It’s not forced on you.

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