Navigating Clinical Trials

Are you looking for treatment options beyond standard therapy?

People with GIST are often offered the option of treatment in a clinical trial when all approved standard drug therapies have failed to control progression of the disease. Many clinical trials study new cancer treatments that may apply to GIST. They can also be a study which combines existing treatments, such as the use of other interventions like radiation therapy, surgery and many others. Therefore, patients and their doctors must work together to make an informed decision on the next appropriate treatment option.

Steps For Navigating ClinicAL Trials

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Understand Your Role in Your Care Plan

Patients are the ultimate decision makers in their care plan. Therefore, it is important for patients to recognize the responsibility for managing their care. It is important that you understand your diagnosis since the accuracy and efficacy of a treatment plan depends on the cancer’s type and stage. Therefore, you should learn as much as you can about your specific diagnosis.

Find Clinical Trials Options

You or with the help of your doctor, need to research a clinical trial that would work best for you. Based on your diagnosis, condition, and treatment stage you can search for different clinical trials that can potentially be the best fit for you. Search for clinical trials

Analyze the Goals of Treatments

Your doctor may suggest clinical trials treatments that aim to slow, stop, or eliminate the cancer. He or she may also recommend palliative treatment to manage symptoms and side effects. Be sure your doctor explains to you the goals for your treatment plan and how it will affect you and make sure it aligns with your personal goals for treatment. If you still have any doubt or concern, do not hesitate to seek a second opinion from another doctor.

Gather All the Information You Will Need

Before visiting the clinical trial in which you are planning to participate, make sure you collect and organize all your medical information, such as:

  • Your treatment history
  • All your CT, PET, or MRI scan reports
  • Your GIST mutational testing reports

Get the Proper Support

Enlist the help of a relative, partner, or a friend who can:

  • Help you with emotional support
  • Be a second pair of ears
  • Be your spokesperson or advocate
  • Help you with research, billing issues, or navigating your treatment plan

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Set the Criteria

To choose the best clinical trial is a major challenge. It is important to assure you are choosing the clinical trial that is the best fit for you. Therefore, decide on a set of criteria that are important to you. This will keep you focused. These are some examples:

  • Make sure to read thoroughly the specifications of the clinical trials
  • Confirm that the qualifications of the clinical trials match you
  • Consult with your doctor concerning the clinical trials protocol and treatment plan
  • Make sure that the location of the clinical trial is the one nearest you, since some clinical trials tend to have various locations around the country or state
  • Ask about the phase of the clinical trial
  • Make sure to read research studies results or preliminary results of similar clinical trials
  • Talk to other patients who have already been part of or are currently part of a clinical trial

Ask Questions

The Life Raft Group believes in “Patient-Powered Science”. Therefore, we encourage you to take an active role in your own treatment. Be curious! and feel free to ask any questions or bring up any issues concerning the trial at any time. The following suggestions may give you some ideas as you think about your own questions:

  • What is the main purpose of the study?
  • Why do researchers think the approach may be effective?
  • What are my possible short/long-term benefits or risks?
  • What kinds of therapies, procedures and /or tests will I have during the trial?
  • What are the chances it will benefit you?
  • How are study results and safety of participants being checked? And how often?
  • What are the options if the trial does not work for you?
  • How long the study will last?
  • Is the trial focused only on GIST patients or a broader group of patients?
  • Will I have to pay for any part of the trial such as tests or the study drug? If so, what will the charges likely be?

Understand the Role of Statistics

Your doctor may mention different statistical values when describing your treatment options. These may include relative survival rates, disease-free survival rates, and progression-free survival rates. These numbers may be an effective way to learn how the treatment options differ. But they can’t predict how well the treatment will work for you. Your doctor or another member of your health care team can explain how these statistics relate to your treatment.

Ethical guidelines

The main focus of clinical research is to develop knowledge that improves human health. This can be possible thanks to the people who participate in clinical research. The path to finding out if a new drug is safe or effective is to test it on patient volunteers, placing some people at risk of harm for the good of others. Therefore, the purpose of ethical guidelines is both to protect patient volunteers and to preserve the integrity of the science. The United States government has strict guidelines and safeguards to protect people who choose to participate in research studies. Each study that uses human subjects must be approved and monitored by the Institutional Review Board (IRB).

IRB Review

Clinical trials are approved and monitored by an Institutional Review Board (IRB) to ensure that the risks are minimal and are worth any potential benefits. An IRB is an independent committee that consists of physicians, statisticians, and members of the community who ensure that clinical trials are ethical and that the rights of participants are protected. Potential research participants should ask the sponsor or research coordinator whether the research they are considering participating in was reviewed by an IRB.

Informed consent

Before you are allowed to participate in a study, you will be asked to sign an “informed consent form”. Informed consent is the process of learning the key facts about a clinical trial before deciding whether to participate. The research team provides an informed consent document, which includes such details about the study as its purpose, duration, required procedures, and who to contact for various purposes. The informed consent document also explains risks and potential benefits. It is important to emphasize that the Informed consent is not a contract. Volunteers are free to withdraw from the study at any time.