Why should I consider a clinical trial?
Clinical trials are an essential part of bringing newer, better drugs and interventions to patients. All drugs must go through a rigorous clinical trial process before approval. As such, clinical trials have a number of benefits, both for the individual volunteer and for society. Clinical trial participants are the first to access new treatments or interventions. Clinical trial research teams usually include top doctors and scientists, and patients tend to be monitored more closely as part of a study than during routine care. Regardless of personal benefit, all clinical trial participants help future patients by contributing to research that determines the best treatment approaches.
Why participate in a clinical trial?
People choose to participate in clinical trials for a variety of reasons. The currently approved drugs may not be very effective for their specific diagnosis or may be associated with significant side effects. Clinical trials can provide access to treatments or procedures that are not yet widely available. People who participate in clinical trials are closely monitored by clinical trial staff for disease progression and side effects, which many people find reassuring. Others who volunteer for a clinical trial want to contribute to research that can help future patients.
Why are clinical trials important?
Clinical trials are essential to developing better treatments and ways to treat patients. All of the approved drugs that are a part of the current standard of care for people with cancer have undergone a rigorous clinical trial process before approval for use in routine patient care. For example, clinical trials showed that patients with metastatic melanoma (Stage IV melanoma) responded better and lived longer when treated with certain targeted therapies and immunotherapies. These trials led to the approval of a number of drugs and drug combinations starting in 2011 and continuing to this day. As a result, people with melanoma today have access to much better treatments, and many are living longer and with fewer side effects.
Clinical trials in melanoma continue to evaluate new treatments, treatment combinations, treatment sequencing, and other interventions. Clinical trials answer important questions like: Does a new treatment work in people? Is it better than current treatments? Is it safe? Does it cause fewer side effects than current treatments? Do the benefits of this treatment outweigh the risks? Several trials across different phases are usually needed to answer these questions.
What is the value for patients?
Clinical trial participants have potential for the earliest access to treatments, interventions, or combinations of treatments that are not yet approved or widely available.
Patients may also benefit from the regular and close monitoring from the clinical trial staff. Clinical trial teams typically include top doctors and scientists. More frequent office visits and monitoring can also mean that any issues might be caught earlier.
There may be a cost-benefit of participating in a clinical trial. For example, the study sponsor sometimes pays for the study drug, with routine care costs covered by insurance. It is important to understand what costs you will be responsible for before agreeing to participate in a trial.
What is the value for society?
Clinical trials are necessary for the development of better treatments for future patients. Regardless of whether you personally benefit from the treatment received as a volunteer who participates in a clinical trial, by participating you contribute to research to determine the best treatments, procedures, or treatment sequencing for future patients.
Will I be a guinea pig?
The goal of a clinical trial is to answer a scientific question (for example, how well a particular drug works in certain patients), but that does not mean you will be a “guinea pig.” People who participate in clinical trials can expect to receive excellent care and be fully informed about the trial before deciding to participate.
In randomized trials, it is possible that you will be assigned to a control group instead of the group that receives the new treatment or intervention. Although control group participants do not get the new treatment, they still receive the standard of care (meaning the best treatment currently approved for their condition). Placebos are now rarely used in clinical trials for people with melanoma because there are several approved treatments.
You may be asked to have additional tests done or complete other activities for the purpose of the trial that would not otherwise be part of typical cancer treatment. For example, some clinical trials include extra blood tests to help find biomarkers to predict which patients respond best to a particular treatment. You may need more frequent scans or laboratory tests to see how well the cancer is responding to the treatment. Side effects are monitored more closely during a clinical trial. In some cases, you may be asked to periodically complete surveys, medication logs or symptom diaries. All of the procedures in a clinical trial, including any additional testing or activities that you may be asked to complete, are laid out in the study protocol before the trial can begin. Each protocol goes through a strict expert review process by the Food and Drug Administration (FDA) before the trial starts, and any changes also go through the same strict review process. Your doctor and the research team can answer questions about what additional monitoring or testing may be needed for a particular trial before you agree to participate. You will not be expected to complete any tests or procedures for the trial that are not already mentioned in the protocol without additional discussion between you and your healthcare team.
What ethical considerations guide clinical trials?
Clinical trials must adhere to strict rules to make sure they are conducted ethically. Before a clinical trial can begin, a detailed, rigorous plan for the study, called the protocol, must be approved by teams of experts including the FDA and an Institutional Review Board (IRB), which is a separate regulatory and ethics board, to make sure the trial is conducted fairly and safely and that patient rights are being protected. While the trial is going on, groups of experts closely watch the results and can stop the study if needed, including for safety concerns or if a new treatment is clearly much better (or worse) than the standard.