What You Need to Know
What You Need to Know
Why are Clinical Trials so Important?
Every drug you take or medical device you come in contact with has gone through the clinical trial process. Clinical trials are the vital step in developing new, safe treatment options that benefit patients with cancer and other diseases. They also can offer the opportunity to receive a promising new drug or treatment that may be an improvement over the current standard of care.
What is a Clinical Trial?
A clinical trial is a research study whose goal is to investigate new treatments or new combinations of treatments around a particular medical (i.e., drugs or devices), surgical or behavioral intervention. It is the main way researchers learn if a new drug or medical device is safe, effective, and/or improves the quality of life in a patient population living with cancer or other diseases.
WHY ARE CLINICAL TRIALS SO IMPORTANT?
Every drug you take or medical device you come in contact with has gone through the clinical trial process. Clinical trials are the vital step in developing new, safe treatment options that benefit patients with cancer and other diseases. They also offer you the opportunity to receive a promising new drug or treatment that may be an improvement over the current standard of care.
Is A Clinical Trial Right For Me?
Each trial is unique with its own set of benefits and risks – just as with any medical test, drug, or procedure. It is important for you to gather data to help inform your decision about participating or not.
Questions to ask your doctor or the trial researchers to help you decide about participating include the following:
- Why is this study being done? What do the researchers hope to learn?
- Will the researchers work with my current cancer physician and care team? Who will be in charge of my care?
- What are my other options (standard treatments, other studies)? What are their pros and cons?
- How much experience do you have with this investigational drug treatment? What is your experience with clinical trials?
- What kinds of treatments and tests are part of this study? How often are they done?
- Does the trial involve a placebo or a treatment that is already on the market?
- How will the treatment be given to me?
- What side effects can I expect? Are there other risks? How do they compare to side effects from standard treatments and from the disease itself?
- Will I have to be in the hospital for any part of the trial? If I do, how often, how long, and who pays?
- Will I still see my regular cancer doctor? Who will be in charge of my care during the trial?
- Will I have to pay for anything? Will any of the treatment be free? Will my insurance cover the treatment?
- How long will I be in the study? How long will the study last?
- Are there reasons I could be removed from the study?
- Is long-term follow-up care part of the study? What does that include/involve?
- If the treatment is working for me, can I keep getting it after the study ends?
- Can I talk to other patients already taking part in the trial?
- Will I be able to find out about the results of the study?
- How long do I have to make this decision?
Once you have spoken to your doctor about the trial, it can help to sit down and make a list of the pros and cons for you personally. It can help to write down both on one sheet of paper – cons on one side, pros on the other – and then making the decision. Here is a template you can download and print out to help with your decision.
Health Insurance And Clinical Trials
Although federal law requires most health insurance plans to cover routine patient care costs in clinical trials, find out what is and is not be covered by your insurance company and the trial, so there are no surprises. Talk with your healthcare provider, the research coordinator, and your health insurance company to learn who will cover which expenses.
Your Rights As A Clinical Trial Participant
The Patient Bill of Rights protects those who volunteer to participate in clinical research as a patient or healthy subject. Before you enroll in a trial, you have the right to:
- Understand all the possible benefits and risks involved.
- Understand how long the trial will last, where it will be conducted, and the overall plan for the trial.
- Understand what will be expected of you as a participant in the clinical trial.
- Make your participation voluntary, but your intent is to complete the trial prior to enrolling.
After you enroll, you have the right to:
- Decline participation or withdraw at any time without the loss of future treatment.
- Ask questions and voice concerns regarding the new drug or treatment.
- Stay informed of all the latest findings during the clinical trial that may affect your commitment to participation.
In addition, there is a process known as Informed Consent where participants learn about the trial before deciding to enroll. The trial research team explains the purpose, how long it will take, what will happen, all potential risks and benefits, and information on the privacy of your medical records.
If you choose to participate, you sign a consent form that details all of the information that has been discussed. And remember: Even though you signed the consent form, you have the right to leave the trial at any time, for any reason.
Informed consent continues throughout the trial. This gives the research team an opportunity to update you on the progress of the trial as well as any side effects or other risks that have been identified.
Common Myths About Clinical Trials
Patients will get a placebo and not the experimental drug or treatment.
Cancer trials rarely use placebos alone. These trials are comparing the standard treatment with a new, investigational drug or treatment. If there was any possibility a patient might receive a placebo, that would be made very clear in the informed consent process. Remember the goal of any trial is to improve the treatment over the current standard of care, so patients receive the current standard treatment at minimum.
All of the costs of the trial will be covered. Patients don’t have to pay anything to participate.
While insurance companies are required by law to cover the cost of participation in a qualifying cancer research protocol, some people who participate in a trial may have to pay deductibles associated with the standard of care treatment. Experimental drugs are frequently provided free by the sponsoring drug manufacturer. Health insurance may cover charges related to tests and treatments carried out during a clinical trial that would be done anyway for standard treatment. Patients are urged to carefully review the informed consent document about the costs and speak with your insurance company.
If a patient is not eligible for one trial, they will not be eligible for any.
Each trial has very specific eligibility criteria; just because the patient is not eligible for one trial does not mean they are ineligible for another trial. It just means they don’t meet the criteria for that one specific trial.
Sources For Finding Clinical Trials Looking For Eligible Patients
Below are sources where you can find clinical trials looking to enroll patients.