ASCO® Cancer.Net: Doctor-Approved Patient Information 

What are Clinical Trials?Reviewed 2013.

Richard Goldberg, MD; Member, American Society of Clinical Oncology: So clinical trials are the way we make progress in medicine. And what they are, is a way of taking patients who are similar, treating them in a similar way, and then seeing how they do. And the idea of that, is if you do it in a deliberate way, you can learn things that you can not learn when you just do it as an ad hoc method.

Why Participate in a Clinical Trial?

Dr. Goldberg: Why would someone want to go into a clinical trial? There are several reasons. One is that you may get access to brand new drugs that will work better against your cancer than standard drugs. Another is that you're contributing to the progress that we make against cancer. Those are two very strong reasons to consider enrolling in a clinical trial, but you want to be sure that the details feel right to you before you enroll in one.

Phases of Clinical Trials

Dr. Goldberg: Clinical trials are done in what we call phases. Phase 1 are the earliest clinical trials and that may be the first in man study of a drug or it may be a combination of drugs that haven't been combined before. And the goal of that is both to see how active the drugs are, but also to see how they can be safely combined. A phase 2 clinical trial takes one population with a cancer, so somebody with colorectal cancer or a number of patients with colorectal cancer, and treats them 1 way. It observes how they do. And if that treatment looks promising enough, then it'll go into a phase 3 trial.

A phase 3 trial takes a new treatment or combination of drugs and compares them to the standard of care. And that's how we really make progress is replacing old standards of care with better ones.

Patient Safety

Dr. Goldberg: Safety is a very important part of clinical trials. In many cases, there'll be what's called an independent data safety monitoring board. That's a group of people who are experts in the kind of treatment that you're looking at, who would have access to all of the side effect information and the activity information so that they can police it and be sure that there no unexpected side effects.

In addition, the individual principle investigator, or the person running the trial, is responsible to have oversight of all of the side effects, very commonly will deliberate carefully over unanticipated side effects to be sure that we don't need to modify the trial for future patient safety.

Clinical trials are really the way we've made progress in cancer treatment. And we've made tremendous progress over the last 50 years and treating people with all kinds of different cancers. A patient can always opt out at any time. And so most patients who enroll in clinical trials are treated well on them and don't ever opt out. But you have to be comfortable in order to enroll in one.

Where to Learn More About Clinical Trials

ASCO’s Cancer.Net, which is its patient-orientated website has particular information about clinical trials in general, and specifically. It also has links to other websites where you can find out more specific information.

[Closing and Credits]

Cancer.Net®: Doctor-Approved Patient Information from ASCO®

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