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Clinical trials are managed with a protocol.
A protocol is essentially the rule book 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.
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.
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.
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.
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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