Should I Participate In a Clinical Trial?

What is a clinical trial? Does it impact the care of a cancer patient? These are the questions that puzzle many cancer patients. By participating in a clinical trial, a drug, regimen or device is studied and evaluated as a possible new therapy. A clinical trial provides more information for the healthcare team. It can provide hope or for many patients who have no further treatment options, by participating they may receive the treatment before it is widely available.

The goals of clinical trials

Clinical trials are medical studies that try to find new, safe and effective ways to manage diseases. It may include strategies to prevent, diagnose, or manage diseases. Clinical trials or studies evaluate promising treatments that help provide information about the effectiveness as well as the treatment’s risks.¹

Understanding clinical trials

The following aspects are the component parts of every clinical trial and will help the patient understand if it is something of interest:

• Purpose: The trial will clearly include the type and objectives. It may examine tests, procedures, medications or new approaches to manage a disease.
• Phases: These are the steps in the research process. The scientific process is quite detailed from Phase I to Phase IV. It evaluates the best dose and effect from small groups, to larger groups and eventual approval by the FDA. (US Food and Drug Administration)
• Protocol: Each clinical trial follows a predetermined and approved step. The format includes goals of study, eligibility, details about tests, procedures and treatments. Before joining, the research team will discuss details of the study, what procedures will be done, the time involved and if interested the patient will be asked to sign an informed consent document.
• What to expect: The healthcare team will include physicians, nurses, and social workers. Examination and diagnostic tests will be included and may require travel to a medical center. There are eligibility requirements which state certain criteria to be met such as age, stage of disease, past treatment, current physical condition and lab results.²

Clinical trials follow scientific requirements. To avoid bias, there is a process called randomization, which is used in some studies where participants are assigned randomly to either treatment. The results of each treatment are compared. Studies may also be blinded so the research team cannot impact results. The information gathered from the trial is evaluated and researchers make key decisions at this point. After a phase I and II, researchers decide whether to proceed to next phase or stop the trial depending on the results found.²

Clinical trial results

Clinical trial results are published and shared at scientific meetings. If proven effective, the treatment may become the new standard of care.²

When first diagnosed with non-Hodgkin lymphoma, I explored all available clinical trials. Unfortunately, there were none available where I met eligibility criteria. However, the chemotherapy protocol recommended by both my primary oncologist and a second oncologist at a tertiary center was the result of a recently published clinical trial. The combination chemotherapy and monoclonal antibody demonstrated improved overall survival and provided another option for treating this cancer.

Grateful for clinical trials

Although I did not participate in a clinical trial, I greatly benefited and am grateful to those patients who took the time and effort to join a clinical trial. Clinical trials allow researchers to find new treatments, give hope to patients, and allow patients to find and benefit from the latest treatments.