If you qualify for a trial, your care team will provide you with all applicable information. They will tell you, in a process called informed consent, how the trial will be conducted and the possible risks and benefits of participating in the trial. You will then sign a document stating that you understand the details of the trial and that you are willing to participate. Even after signing the document of informed consent, you may withdraw from the trial at any time for any reason.

Through the process of informed consent, your medical team will make sure you understand all the possible risks and benefits. Because clinical trials typically test investigational treatments, side effects and its effectiveness against the cancer may be unknown. Since risks vary in each individual situation, it’s important to talk with your medical team to understand the specific risks related to any clinical trial you may be considering.

Clinical trials are conducted according to strict scientific and ethical principles, and groups of experts at the national and local levels approve research studies before they begin. One important group that evaluates clinical trials is the Institutional Review Board (IRB) of the research organization implementing the trial. An IRB is made up of doctors, researchers, community leaders, and other members of the community. The IRB is focused on protecting the safety of study participants by reviewing the protocol to make sure the study is conducted fairly, and participants are well-informed of their rights during the study.

Every clinical trial includes a protocol. This is a study plan that is carefully designed to protect the health of study participants and answer specific research questions. A protocol specifically outlines the purpose of the trial and includes details such as who is eligible to participate, how many patients will be enrolled and how the data will be collected. The protocol is carefully developed and reviewed by the lead investigator(s) and the sponsoring organization, such as a pharmaceutical company. It is then reviewed and approved by an IRB to ensure trial procedures are consistently carried out. This protocol is followed by every investigator taking part in the trial.

Two types of costs are associated with a clinical trial: patient care costs and research costs.

• Patient care costs are those costs related to treating your cancer, whether you are in a trial or receiving standard therapy. These costs are often covered by health insurance and usual copays and coinsurance would apply. Doctor visits, hospital stays, standard cancer treatment, lab tests and imaging tests are considered patient care costs.
• Research costs are those related to taking part in the trial. Often these costs are not covered by health insurance but are usually covered by the research trial’s sponsor. Study medicines as well as additional lab or imaging tests performed solely for the trial are examples of research costs. Travel and accommodation for the study may also be covered.

When you take part in a clinical trial, you may have extra care team visits that you would not have with standard treatment. During these visits, your care team carefully watches for side effects. These extra visits can add costs for transportation and childcare.

Yes. Most clinical trials do not provide complete primary healthcare.

No. Your participation in a clinical trial is completely voluntary at all times.

Yes. Cancer research participation is strictly voluntary. Participants may withdraw their decision to participate at any time for any reason. When withdrawing from the clinical trial, you should let the research team know about it and the reasons for leaving the study.

If you are interested in a clinical trial, you should talk to your care team about setting up a meeting with a research coordinator or study investigator to learn as much as possible about the study.

There is a lot to learn regarding clinical trials. To ensure that you gather all the necessary information, you should come prepared with a list of possible questions to ask about the study, including its purpose, the procedures involved and any expenses you’ll have. You might also want to bring a device that can record the discussion. Additionally, consider asking a friend or relative to join you for support and to hear the responses to the questions.

No. Typically, patients who participate in a clinical trial can keep seeing their current oncologist. Maintaining a relationship with your oncologist is important for continuity of care.

Patients who participate in clinical trials will have their cancer followed with routine tests to evaluate whether the treatment is working. In most cases, the treatment is continued as long as it appears to be working.

After the study treatment is complete, participants will continue to be followed for months or even years for health updates. If the participant changes to another care team, the research staff may contact the participant via phone.

All information collected is analyzed to help determine the investigational treatment’s safety, side effects and effectiveness. FDA medical advisors and specialists closely review this data before considering any new therapy for approval. Once a treatment is approved, studies continue to compare the new option with other therapies already on the market. Other studies may research whether the treatment can be administered to a new patient population, its long-term effectiveness, and its impact on patient quality of life.