The First Step is Determining a Patient’s Eligibility for a Clinical Trial
In general, patients must
- Have their general health status reviewed by a physician
- Have their cancer diagnosed and “staged,” which means evaluated for how far it has spread
- Have all their treatment-related and clinical trial questions answered to their satisfaction
- Sign an informed consent document, which means they understand the possible risks and benefits and agree to participate in a clinical trial
Informed consent is the process of learning the key facts about a clinical trial before deciding to participate. It is also a continuing process throughout the study.
- To help someone decide whether to participate, the research team involved in the trial will explain the details of the study.
- If the participant's native language is not English, translation assistance can be provided.
- The research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts.
- Risks and potential benefits are explained in the informed consent document.
Informed consent is not a contract, and the participant may withdraw from the trial at any time.
Once a patient gives informed consent, his or her level of involvement depends on the type of study. Some studies are as simple as filling out a questionnaire while others may involve additional tests and clinic visits than standard treatment would require.
- Patients who enroll in a study are not set apart—they are treated in the same facilities and seen by the same health-care providers as non-study patients.
- All patients receive the same high level of care, whether they are in a study or not.
- Participation in a clinical trial is voluntary and patients may withdraw at any time.
Considerations Before Participating in a Clinical Trial
Patients should know as much as possible about the clinical trial and feel comfortable asking questions. The following questions might be helpful for the participant to discuss with the health-care team. Some of the answers to these questions are found in the informed consent document.
- What is the purpose of the study?
- Who is going to be in the study?
- Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before?
- What kinds of tests and experimental treatments are involved?
- How do the possible risks, side effects, and benefits in the study compare with my current treatment?
- How might this trial affect my daily life?
- How long will the trial last?
- Will hospitalization be required?
- Who will pay for the experimental treatment?
- Will I be reimbursed for other expenses?
- What type of long-term follow up care is part of this study?
- How will I know that the experimental treatment is working? Will results of the trials be provided to me?
- Who will be in charge of my care?
The patient’s role in participating in a clinical trial:
- Stay in contact with your research team
- Notify a member of the research team if any of the following occur:
- Any unusual side effects
- You are not feeling well
- Your cancer comes back
- You develop a new cancer
- New medications are started
- New treatments ordered by another doctor
- Your health status changes
- You consider taking herbs or vitamin supplements
- You change doctors
- You change insurance
- You move or change your phone number
- Ensure compliance to the protocol’s treatment regimen.
The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built-in safeguards to protect the participants. Every clinical trial in the United States must be approved and monitored by an Institutional Review Board (IRB) that will evaluate risks and benefits. An IRB is an independent committee of physicians, statisticians, community advocates, and others that ensure a clinical trial is ethical and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research.
“The decision to participate in a clinical trial was an easy one for us. Clinical trials offer access to cutting edge therapies otherwise potentially unavailable, resulting in exceptional levels of care. The importance of this access for patients like my husband, with diseases considered incurable, easily outweighs most treatment-related risks. That he has also contributed to the body of knowledge of disease was both an added incentive and a source of solace to us.”
-Meléne, spouse of multiple myeloma survivor