Clinical Trials 101: The First 3 Questions To Ask

Learning that you have cancer can be an overwhelming experience for both you and your loved ones. Even while your world might feel like it's crumbling around you, time doesn't stop: you must make decisions about next steps in how you’ll treat the disease. The good thing is that there are many options for your therapy. Participating in a clinical trial is one of them.

1. What is a clinical trial?

A clinical trial is a research study that explores whether a medical strategy, treatment, or device is safe and effective for humans. These studies may also show which medical approaches work best for certain illnesses or groups of people.

They are usually the last step in a very long process to approve a treatment for general use. The people who conduct clinical trials are typically called “investigators,” and they can focus on all stages of cancer. Questions being asked in clinical trials are focused on finding new ways to:

• Treat cancer
• Find and diagnose cancer
• Prevent cancer
• Manage symptoms of cancer and/or side effects from the treatment of cancer

Be they drugs or vaccines, ways to do surgery or give radiation therapy, or combinations of treatments, clinical trials test many types of treatments. Something to keep in the forefront of your mind: All treatments that are considered standard of care were once studied in a clinical trial!

2. How am I, the patient, protected?

The federal government enforces rules to ensure that clinical trials are run in an ethical and safe manner. As a patient participating in a clinical trial, you have rights and your safety is ensured in several ways.

Informed Consent. This is an important process that educates you about a clinical trial’s purpose, risks, and benefits, and it is required you receive this information from the research team of doctors and nurses before you decide whether to participate. At this time, you are also informed of your right to

• make a decision about participating, and
• leave the trial at any time.

After discussing all aspects of a trial with you in a way that you understand fully and answering any questions you may have, you will receive an Informed Consent Form. It is a written document outlining all of the information you have learned, as well as details about how your health information is protected. If you are in complete agreement with everything you read, you will sign the form. But remember, even if sign the Informed Consent Form, you always have the right to leave the trial at any time.

Scientific Review Panels (SRPs). Every trial is reviewed by a panel of experts before it can commence and accept participants. Government-funded trials are required to pass this review; many other trials that are sponsored by drug companies or educational institutions ask for a panel’s advice on trial protocol and overall merit of the research planned.

Institutional Review Boards (IRBs). This board is made up of a mix of medical specialists and community members, all from diverse backgrounds. Prior to the trial accepting patients, risks are compared to benefits. Once the trial is underway, the Institutional Review Board (IRB) watches closely to ensure the protocol is being followed and patients are being treated safely and ethically.

Data and Safety Monitoring Boards (DSMBs). Phase 3 trials, as well as some Phase 1 and two trials, require a Data and Safety Monitoring Board (DSMB) oversight to ensure safety. This board is made up of statisticians, physicians and other experts who are tasked with ensuring risks of the trial are being reduced as much as possible, checking that trial data is sound and thorough, and stopping a trial if safety is an issue or as soon as the trial’s objectives have been met.

3. What do I need to think about before I decide to participate in a clinical trial?

Your loved ones and medical team are people on whom you can rely for clarity and reassurance, but choosing to join a clinical trial is a decision only YOU can make. In addition to the fine details of a trial’s protocol, there are pros and cons and questions to consider with your doctor and people close to you.

The Potential Pros.
To begin, consider the very active role you are playing in weighing options about how to treat your diagnosis. You are not only helping yourself by participating in a trial, but you are also helping others as the medical community seeks to improve cancer treatment. As well, clinical trials offer high-quality cancer care. Even in a randomized study, everyone participating receives the best known standard treatment. This may be as good as, or better than, the new approach being tested. If the treatment being tested in your trial is proven to work and you are receiving it, you may be among the first to benefit!

The Potential Cons.
New treatments that are being studied are not always better than, or even as good as, the best known standard of care. In some randomized trials, you may not receive the new treatment, and if you do, there may be side effects that doctors do not anticipate or that are worse than the standard treatment.

Health insurance coverage will vary from plan to plan, and some patient care costs may not be included in your benefits. It is critical you check with your insurance provider and the billing staff of the hospital, doctor’s office, or health clinic you are visiting. If you are thinking about taking part in a clinical trial, there are many questions to ask. An ACCESS Patient Navigator is available to walk you through each step of the process.

Did you consider participating in a clinical trial for your cancer treatment? Share in the comments below or sign up here.

Photo courtesy of Farrel Nobel.