Dr. Eric Singer explains how clinical trials are reviewed to ensure the safety of the patients involved.
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Cancer Clinical Trials: Safety Rules and Requirements
Eric Singer, MD, MA: Clinical trials are managed with a protocol. A protocol is essentially the rulebook that researchers use when they're running a trial.
An important part of the protocol are the eligibility requirements and eligibility criteria include inclusion criteria and exclusion criteria.
Inclusion criteria are used to keep all the patients on the trial to make sure that they have the same sort of medical problems and essentially, this would be – in a cancer trial, looking at patients who have the same type of cancer and the same stage of disease, for example. And so essentially, inclusion criteria is used to keep the groups that are being compared the same.
Exclusion criteria are really focused on patient safety so that if a trial is looking at a drug that requires the patient to have healthy kidneys, a person with kidney disease may not be eligible. So exclusion criteria are used to make sure that the patients who are going on to the protocol aren't at increased risk of having something bad happen.
Safety Reviews in Cancer Clinical Trials
Dr. Singer: Clinical trials are crucial to all aspects of medicine and not just cancer care, but I think they get a special attention in cancer because the stakes are so high. Patients are facing something that's very distressing and can be life-threatening. And so it's important to make sure that when we come up with a new treatment, that it actually is safe and effective so that we’re helping our patients with these new treatments.
When you’re finding out more about clinical trials, you may hear people refer to an institutional review board, or an IRB.
Institutional review boards are made up of physicians, researchers and members of the public who serve as patient advocates. Institutional review boards are critical to the safety of research subjects and all clinical trials in the United States are required to be approved by an institutional review board before they can open.
What is a Data Safety Monitoring Board?
Dr. Singer: A data safety monitoring board is another form of oversight to look at safety for the patients involved in clinical trials. The data safety monitoring board looks at the data, not just from one site, but from the information coming from every single site and looks to make sure that there are no unexpected problems that are happening that were anticipated in the consent form for the original protocol.
In addition, the data safety monitoring board has scientists who are specially trained in statistics. So in addition to safety, they're also looking at the scientific validity of the study. What this means for patients is that if a trial is ongoing and the data is so compelling that the new treatment is much better than the existing one, the trial can be stopped early so that the other patients can get the new treatment.
Conversely, if they find that there are many new problems or that there's no chance that the new drug could be better than the one that's going – that's already being used, they can stop the trial early to prevent these patients from being exposed to increased risk.
Talking With Your Doctor about Clinical Trials
Dr. Singer: It's absolutely important for patients to talk to their doctors about their clinical trials, not only what trials are being offered, but also how the trials are designed and the safety involved with them and their oversight. Like all aspects of cancer care, patients need to educate themselves and ask questions of their health-care providers.
Where to Get More Information
Dr. Singer: While there are numerous resources available for patients online, I think two of the best available are from the National Cancer Institute, which is cancer.gov, and also from ASCO, which is at Cancer.Net.
After visiting cancer.gov or Cancer.Net and identifying some clinical trials that may be of interest to you with your oncologist, there are several questions you may want to keep in mind when you speak to the research team, the first of which is: Are you eligible for this protocol?
In addition to whether or not you can participate in the trial, things you may want to keep in mind is: Where is the trial being offered? How much travel is involved? And how does the schedule of the protocol impact your life?
You'll want to ask the researchers about what kind of steps have been taken to minimize risk and maximize potential benefit for you participating in this trial. Lastly, you'll want to know what’s the expected time at which you’ll be on the trial and then how long would you be expected to be followed once you've completed the trial.
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