While being treated at Ironwood Cancer & Research Centers, your physician may recommend that you participate in a clinical trial (a study). This could include receiving an experimental treatment, meaning the drug or combination of drugs has not been approved by the Federal Drug Administration (FDA) for the disease being investigated, or could only involve a review of your medical records to collect information on your medical history, treatment and response to treatment. Participation is entirely voluntary and in most cases does not include reimbursement other than costs attributed directly to the trial.
Clinical trials are regulated by both the FDA, an agency within the United States Department of Department of Health and Human Services, and an Institutional Review Board (IRB), a group responsible for reviewing trials and research sites to assure the design and conduct are keeping trial participants safe and that participants’ rights are being protected. Safety and the protection of participants’ rights are always of the utmost importance during trial participation.
What to Expect In a Clinical Trial:
If your physician recommends trial for you, participating will be up to you and will generally include 4 stages:
1. The Informed Consent Stage
Your doctor and the Research staff may approach you to review with them the recommended trial’s Informed Consent Form, which is a regulated document that assures you, as a trial patient, completely understand what the risks, benefits, treatments, procedures, and requirements of the trial are. It is also important that during this process, you understand what your physician recommends for treatment if you decline to participate in the trial so you understand all of your treatment options and can decide what will work best for you. A member of the Research Staff and your doctor will work with you to answer all of your questions to your satisfaction. We encourage you to discuss participating not only with your doctor at Ironwood but also with your family, friends, and any other doctors you are seeing. When you make the decision to participate, you and the Research staff member will both sign the trial’s Informed Consent Form and a copy will be given to you and also included in your Medical Record. The option will also be given to you to have your Primary Care Physician informed of your participation.
2. The Screening Stage
After you have decided to participate and have signed the Informed Consent Form, you will enter the screening phase, where a variety of procedures will be completed to verify that the trial will be safe for you and that certain trial-specific eligibility criteria are met. Procedures you may come across during the screening process include, but are not limited to:
- Confirming your medical history and prior treatments
- Confirming your current medication
- Blood tests
- Electrocardiograms (ECG)
- Echocardiogram (ECHO)
- Multiple Gated Acquisition (MUGA)
- Computed Tomography (CT) Scan or Magnetic Resonance Imaging (MRI)
- Bone Scan
- Physical Exam
3. The Treatment Stage
Once it has been determined that you meet all of the eligibility criteria and it is safe for you to enter the study you will be assigned to a treatment. Most studies are randomized, which means you will be assigned to a treatment group by chance, like flipping a coin. Neither you, nor your doctor chooses which treatment you are assigned. Treatment assignments are done this way to prevent bias and provide meaningful study results. Treatment assignments generally fall into two groups:
- Control group – the control group gets the best known standard treatment which may be as good or better than the investigational new treatment.
- Investigation group – the investigation group get the new treatment, or in some cases the best known standard treatment (same as the control group) plus the new treatment.
In cancer studies you will always receive the best known standard treatment. In studies where the investigation group is getting the best known standard treatment plus a new treatment, the new treatment may be an active drug or a placebo. A placebo is made to look like the new treatment or medicine but is not active.
In some studies, you and your doctor will know which treatment group you have been assigned to. In other studies, neither you, your doctor, nor the Research Staff will know what treatment you are receiving. This is what is called a double-blind study. Like randomization, this is done to provide meaningful and unbiased study results.
During the treatment stage, you will be carefully monitored and followed by the Research staff and your doctor. You should report any problems or symptoms to them right away so that they can ensure you receive the care you need. Your safety and well being is their main priority.
4. The Follow Up Stage
You will remain on the study treatment until it is determined your disease is getting worse, you have unacceptable side effects, or until you or your doctor decide it is no longer in your best interest to continue.
When you are no longer on study treatment you will still continue to be part of the study, if you agree, for follow up information. You will continue to be followed to determine your health condition, subsequent treatments and overall wellbeing. This information continues to be of great importance to the study results.
Costs of Participation:
Generally, you will not be paid to participate in a study. Investigational drug is provided free, however, any standard of care (care you would receive regardless of study participation) treatments and procedures will continue to be billed to you or your insurance carrier. Any extra test, procedures or treatments that would not normally be done as part of your care but are needed for the study, are paid for by the study.
The research staff can provide you with information regarding any procedures or tests that are paid for by the study.