Benefits and Risks
Clinical trials can benefit patient volunteers, patients with conditions similar to the volunteers, and many others. Trials offer early access to the latest treatments at little to no cost to patients (the device or treatment is usually provided by the investigator). Clinical trial staff are trained specifically on the patients’ condition so that they can provide optimal care. Another benefit is that patients get the opportunity to learn more about their health condition while contributing to research that could save lives. In some clinical trials, patients may find that the new treatment can lead to remission or improve the quality of their life. However, these outcomes are not guaranteed. There are risks associated with participating in a clinical trial.
The majority of treatment trials are randomized, so patients may be placed in a control group and not receive the new treatment. Also, the trial design may conceal or ‘blind’ both the patient and the local care team as to which specific treatment is being administered. This can eliminate any inherent biases by those measuring and reporting outcomes. For example, vials of trial medication may only be identified by code numbers-not drug names. If a patient does receive the new treatment they may experience adverse side effects or find that it is not as effective as their current treatment. Trial organizers have access to the coded data. In this situation the central leadership of any blinded, randomized clinical trial bears responsibility to closely monitor trial progress and intervene if unexpected outcomes or hazardous trends emerge. Participating in a clinical trial can also be time consuming and costly. Each trial has risks and benefits specific to its topic of study; the trial team should make these known to participants before they decide whether to enroll in the trial.
General Process
The process of enrolling in a clinical trial varies from trial to trial. Here is a general outline for what it may look like:
- Search for clinical trials that are recruiting patients (some trials are invitation only so you may be recommended by your physician).
- Consider the inclusion/exclusion criteria to make sure you are eligible.
- Consult your physician and contact the trial team member listed on the posting. With the help of their physician and/or patient advocate, the patient volunteer should determine which clinical trials are the most appropriate.
- Review the trial and its structure keeping in mind the Good Clinical Practice criteria.
- Qualify to participate. In order to join a study a patient must receive approval from their primary care physician and the trial investigator.
- Enroll in a study.
- Verify your health status. Before being fully accepted into a trial you will need a physical exam and screening tests.
- Pre-assignment. In this stage a participant is enrolled in a trial, but has not been assigned to a specific treatment pathway, or treatment arm, group.
- Arm group assignment. Arm types are categories that determine whether a patient receives treatment and what type. Depending on the specific condition being studied, the arm types can include a no intervention arm, a placebo/sham comparator arm, or an experimental arm.
- You may withdraw from the study at any point without penalty. You will likely resume a recommended ‘standard of care’ treatment protocol.