What
Should You Expect from the Clinical Trial?
You should be comfortable
and know you will be treated well when you participate in a trial. You
certainly hope the trial will be a
success and your cancer will be managed (or even cured, but that is unlikely),
but you know that there are no
guarantees. What you can expect is
that your health and cancer status will be monitored closely, that side effects
will be managed expertly, and that study doctors and staff will be responsive
to your questions and needs. If a drug is not currently approved for use, the
drug will be provided free of charge. Some of the tests you will undergo, those
done specifically for the research process (e.g., extra biopsies of your cancer
or blood samples to measure drug levels), are also provided to you free of
charge in most cases. In most clinical trials the routine parts of your care
(that would be done if you were getting standard treatment) are not provided
free of charge, but are billed to your insurance provider.
What
can I expect from my doctor and investigative team?
You can, and should,
expect close attention by a team that is often larger than what you would
encounter during routine care.
You can certainly
expect exceptional care from the whole team. You will almost certainly get more
medical attention than if you were on standard care. You should get regular
reports about your progress. If you don’t‑‑ask!
You’re getting treatment for your cancer and
you’re also helping the investigators. You’re a partner in the trial. Be sure
to ask, early on, who is the right person for you to contact for specific
concerns. Who should you call if you have a question about a scheduling matter,
and who do you call if you are not feeling well, have a new side effect, or if
you have a medical question? Having that information clarified from the start
and having all the right contact information for your research team can go a long way in making the process run
smoothly and comfortably for you. You will almost certainly get more medical
attention than if you were in standard care. You should get regular reports
about your progress. If you don’t—ASK! You’re getting treatment AND you are
helping the investigators.
Am
I free to quit if I want to?
YES! You agreed to
participate, but you always have the
right to quit, whether due to side effects or if you’re not comfortable with
the trial or for any reason you choose. Talk to your doctor and your trial team
before you decide. They may be able to resolve your concerns and answer your
questions so you will be able to stay in the program.
What
if I have side effects? How will I know if I should be concerned?
A new physical or
emotional sensation that is out of the ordinary for you could be an adverse
effect. Tell the nurse and doctor about it right away. It is better if you tell
them sooner rather than later. There may be ways to manage your side effects.
It may also turn out to be unrelated to the trial and could be treated
separately while you continue in the trial.
All of this is
important because an adverse effect from an experimental drug is different from
ordinary side effects, mostly in that less is known about it. It could start
out mild and get worse over time if not attended to; sometimes this can happen
very quickly. It should be brought to the attention of the research team
promptly so they can be evaluated.
Bottom
Line
1 Clinical trials are tightly regulated and
closely supervised by the study team, institutional committees, independent
boards, pharmaceutical companies, and the government. The scrutiny is far more
extensive than that of routine cancer care.
2 Most of your cancer care while you’re
participating in a study will be billed to and covered by your health
insurance. Items that are purely for research, and not done to take care of you,
are generally provided free of charge.
3 It is important to establish and maintain
clear communication with your entire study team:
A Find out which members of the team are the
right contacts for different types of questions and concerns.
B Let your study team know about adverse
effects (side effects) or concerns promptly.
C Don’t try to solve problems that arise on
your own or wait until your next appointment‑‑contact your team whenever you
need to.
4 You are always free to stop being a part of
the study. If you are thinking about stopping, be up front with your doctor and
research team. You may learn that they can solve the problems or address your
concerns without stopping the study treatment.
5 Seek the support of your oncologist, your
primary care doctor, your spouse, and those around you while you are making
decisions about whether to sign up for a study and while you are participating
in the trial.
Post Text Here
To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.
(c) 2012 Tom Beer and Larry Axmaker
