Introduction/Overview
Major Patient Concerns
Misconceptions Regarding Placebos
Outreach Strategies
The Responsibility of the Media
GREG BERK, MD: Welcome.
My name is Dr. Gregory Berk from Cornell University Medical College in
New York City. I'm pleased to have Dr. John Hainsworth, Director of Clinical
Research at the Sarah Cannon Cancer Center in Nashville, Tennessee.
JOHN HAINSWORTH, MD: Thank you.
GREG BERK, MD: Dr. Hainsworth,
today we're going to discuss strategies by which the practicing oncologist,
not just in the academic setting, but in the community setting could potentially
recruit more patients into the important clinical trials that we're interested
in gaining more data from.
I’d like to start by asking you
what you sense, because you do this on a regular basis in a large community
cancer center, are the greatest barriers that we have right now that prevent
patients from going onto clinical trials?
JOHN HAINSWORTH, MD: I guess the first thing I’d
say is that I think that many practicing oncologists for a long time have
had a commitment to clinical trials and actually have worked with cooperative
groups and other places to try to get their patients on them. I think it's
more a matter of figuring out how to help them do that, rather than changing
their minds and mindsets, which they're real negative about.
It's often difficult for practicing oncologists to put
patients on clinical trials. I would say mostly it's a time problem in
that they're busy already. Their putting a patient on a trial takes
extra time usually. It takes extra time to talk to the patient, to educate
the patient about the trial. It takes extra time to follow the protocol,
to fill out the case report forms that are necessary. If the doctor has
to do all of that, it's likely that he won't get it done very often.
What we've had to do in our setting is to do various things
to make that whole procedure a little bit easier for busy practicing oncologists.
Sometimes it's the availability of the trial. But even if trials are available
to them and it means they are going to have to work an extra couple hours
a day to get patients on, they're not going to do that.
GREG BERK, MD: Dr. Hainsworth,
what are the patient's greatest concerns, fears or questions in a general
sense when their oncologist recommends that perhaps they go on a clinical
study?
JOHN HAINSWORTH, MD: I think, in general, patients
are receptive to certain kinds of clinical trials. Almost universally,
if they're told that their doctor is participating in a trial that he thinks
is going to potentially be a better treatment for them, most of the time
they're going to accept that. I think the trials that some patients, and
actually some physicians, have some problems with are the randomized trials
where they either don't understand or don't feel comfortable with a randomization
to treatment. They actually want their doctor to recommend what he
thinks is the best treatment, which he really can't do in the context of
a randomized trials. So those are always more difficult.
GREG BERK, MD: I agree
with you. In this age of information technology where patients are coming
with so much information available, and their doctors may be involved in
important phase III trials where there is a randomization. The press is
already out there. The news is already out there so far in advance of potentially
exciting new therapies. When a patient hears that there is a 50-percent
chance they're going to be randomized to placebo, a lot of them have trouble
with that.
The example I'm thinking about
right now is perhaps the phase III trial in diffuse large cell lymphomas
with CHOP and Rituxan.
JOHN HAINSWORTH, MD: I think that's right. Now nobody
gets placebo, but the randomization to be standard treatment with CHOP
versus the new treatment with CHOP and Rituxan. Some patients would not
get the Rituxan. Yeah, I think that's a problem because they either have
already decided that they want the Rituxan. Since it's a drug that's already
approved by the FDA, they can get it outside a clinical trial. I can tell
you that some of the practicing oncologists in Nashville and in my group
already use CHOP and Rituxan as a standard treatment even though it’s not
proven yet. They have the bias also that CHOP and Rituxan is a better treatment
even though nobody has proven that yet. They won't participate in the trial
because they have the same kind of bias that the patients have about it.
I think it's a little easier when the drug that is being
added is still an investigational drug because then you can tell a patient,
"Well, if you don't go on this trial, there is no way you're going to get
this drug. At least on this trial, you'd have a 50-percent chance of getting
it if you randomize to the arm that it's in." That makes it easier.
GREG BERK, MD: That's right.
JOHN HAINSWORTH, MD: You're
right. In a lot of treatments that’s not the case. You have a reason to
think that the CHOP plus Rituxan is going to be better. If you communicate
that to the patient, they're going to want that, too.
GREG BERK, MD: Thank you,
Dr. Hainsworth. Dr. Hainsworth, I'm curious what you think about the potential
role of physicians, who are participating in clinical trials, reaching
out to their colleagues in their oncology community and even to patient
community. They reach out either through mailings, the Internet, nonprofit
foundations and patient advocacy groups to make them aware of the clinical
studies that they’re in for the purpose of recruiting more patients to
trial. I'm wondering what you think of those methods.
JOHN HAINSWORTH, MD: I think right now the recruitment
of patients to trials is probably easier by going directly to the patients.
There are so many patients now that are very aware of trials and are on
the Internet and in contact with the NCI about where they can go for certain
drugs, [they're] even in contact with pharmaceutical companies that have
the drugs. At least in our center we've had a lot more response from patients
when we publicized the trials through advocacy groups or something like
that, rather than from other oncologists. It's always an issue with oncologists
to send their patients away to another oncologist for a trial, particularly
if the patient is not asking to go. I think that's a practical problem
that sometimes is hard to overcome.
[It's easier] going directly to the patients and allowing
it to be an easy thing to do for patients to allow them to find out where
clinical trials are and how to get into them. It's still difficult because
a lot of patients will see a trial and they're really not eligible for
it. So you do have to screen through a lot of patients who think they might
be eligible, but really aren't.
GREG BERK, MD: There have
been a lot of news reports both in local news and even national news in
recent years with new oncology drugs. The first one that comes to my mind
now is the STI-571 for CML, which has been all over the press—national
news stations, on every television station in the country. There is a tremendous
media hype with a lot of new drugs at their earliest stages of development
that gets patients very excited. But it sometimes gets patients and their
doctors very frustrated because a lot of patients don't quite understand
why they may not necessarily be eligible for such a treatment. I'm just
wondering if you have any thoughts on the responsibility of the media in
this regard.
JOHN HAINSWORTH, MD: Well, yeah! I think the example
you gave was probably a more legitimate drug than some of the other ones
that have been totally blown out of proportion, based on one or two responses
out of a hundred patients. Everybody is excited about the new drugs. Everybody
wants to get away from the traditional chemotherapy drugs. Now for the
first time, there are a number of new drugs that are big possibilities
that are going to improve things.
I guess it's reasonable to have some hype of those kind
of drugs that we're finally getting for the first time. It does create
a lot of false hope in patients when they hear or read about one or two
anecdotal case reports of patients who have done well. They don't mention
the other 35 patients who had taken it and either had bad side effects
or absolutely no cancer effect. Then the patients can't get the drug anyway.
That's a real problem.
GREG BERK, MD: Dr. Hainsworth,
I really appreciate your comments on this important subject today. I'd
just like to close by asking if you have any additional comments on the
subject before we wrap it up?
JOHN HAINSWORTH, MD: I think, in general, today
there are more new drugs. There are more ways for patients to get into
clinical trials than there ever have been before. I think patients now
have access in a lot more ways. It used to be they'd have to go to a major
cancer center to be able to access a lot of new drugs. Those are still
good sources, but now a lot of the major cancer centers are working with
community-based oncologists. There are some programs like ours around the
country that are community-based in themselves that have access to more
and more of these new treatments. And there needs to be, because there
are more and more new drugs now to be tested than there ever have been
before. So I think it's actually a good time for patients to have access
and to be able to get on clinical trials.
GREG BERK, MD: Dr. Hainsworth,
thank you very much for joining us today.
JOHN HAINSWORTH, MD: My pleasure.
