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.
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.
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(c) 2012 Tom Beer and Larry Axmaker