Joining a clinical trial can raise feelings of hope as a new treatment offers the potential to improve your health. However, it’s understandable that you may be unsure about what to expect and may have several questions. It’s important to know what questions to ask, as well as what you can expect before, during and after the clinical trial.
The following questions will help you better understand what will be involved if you join a clinical trial. Once you gather your information, discuss any additional concerns you may have with your health care team to determine if the study is a good option for you.
Before you begin participating in a clinical trial, you will receive informed consent, which provides a straightforward explanation of the clinical trial. A research team member will discuss the clinical trial details with you and answer any questions you have. The research team may conduct a physical exam and review your medical history. A blood test may also be ordered to determine how much of the treatment can be safely given to you and whether the treatment is affecting you as expected.
During the clinical trial, you will receive specific interventions according to the research plan or protocol. Your health will be monitored during the clinical trial, as outlined in your informed consent.
Once the clinical trial ends, all of the information is collected and evaluated to determine whether the study treatment is working, if it is safe and whether there are any side effects. FDA medical advisors and specialists closely review this data before approving any new treatment. Even after a new treatment is approved, pharmaceutical companies will continue to conduct safety, effectiveness and cost studies to compare the new treatment to other treatments already on the market. Additional studies may be held to determine if the treatment can be administered to children or special populations. Some studies assess a treatment’s long-term effectiveness and its impact on the quality of a person’s life. After the clinical trial, you may receive the results of the study, however, the information isn’t always immediately available.
For treatments for a serious illness, the pharmaceutical company might continue providing the treatment to patients who are responding well. Occasionally, a patient will stop receiving the treatment and must wait for the treatment to become available for clinical use.
Prior to joining a clinical trial, potential participants are provided information about a clinical study through a process called informed consent. The information provided through informed consent is intended to protect participants and give information about the risks, potential benefits and alternative treatments to the study. In addition, informed consent may include recruitment materials, verbal instructions, question-and-answer sessions and activities to measure the participant’s understanding of the provided information. Before joining a clinical trial, the informed consent must be signed.
For every study a volunteer participates in, they will receive a document called "Consent to Participate in a Clinical Research Study," which explains the study in straightforward language. After a research team member explains the details of the study, they are asked to sign the document only after carefully considering the commitment and discussing the protocol with family and friends. It is the volunteer’s responsibility to understand the protocol.
At any time after signing the document, the volunteer has the right to change their mind and withdraw from the clinical trial or refuse particular treatments or tests. Sometimes, however, this will make a volunteer ineligible to continue the study.
It’s important you understand what to expect during a clinical trial as well as your role. At Banner Research, our support staff is here to answer any questions or concerns you may have about joining a clinical trial.