Participating in a Clinical Trial
All clinical trials have eligibility criteria – these are called inclusion (“have to have”) and exclusion (“cannot have”) criteria. They exist so that the medicine can be determined to have an effect without other factors affecting the outcomes. Sometimes these criteria keep patients who would otherwise benefit from the treatment from getting it; an unfortunate side effect of how the trial process is currently set up. Determining which trial(s) you are eligible for is one of the first step in narrowing down the possible lists of treatments.
Protocol and informed consent
The two backbone documents for patients are the informed consent and the protocol. The informed consent is what is given to the patient to explain exactly what is going to happen on a trial, when it will happen, and what they can anticipate as possible benefits and side effects. It’s the most important thing for a patient to understand.
Behind that document lies the protocol – it is not designed for patients, but rather given to a clinical trial site (i.e. your hospital, doctor’s office, or cancer center) to be used as their “playbook” to ensure every patient in the trial goes through the same steps. This way, the data from the trial is valid and can be used to compare the treatment to existing ones, and also inform physicians and patients on the benefits and risks of the medicine if and when it is approved for general use.
Clinical trials are conducted to determine if a new therapy or medical device is safe and effective at treating a medical condition. Thus, specific, potential risks and benefits are called out in the informed consent. Reviewing this document before deciding to participate is not only important – it’s mandatory. As a patient, you have the right to be informed of the trial protocol and the anticipated effects on your body (both good and bad), before giving your consent to be a participant.
It’s also important to note that you can withdraw that consent at ANY time. This means your participation in the trial will stop – i.e. you won’t get the medicine – but it is entirely your decision alone to continue or revoke participation in the trial. Sometimes this can affect a patient’s treatment plan, as the drugs in trial are generally not yet approved for treatment of your specific disease (caveat – some drugs being tested will be approved for other disease types, or will only be available after other conditions are met; check with your doctor regarding specific situations).
If you choose to consider a clinical trial, you should review the informed consent carefully with your medical team to ensure there is a clear understanding of what is going to occur and how it will affect you. Never sign anything you don’t feel comfortable with or have questions about – it is your right as a patient to be informed of all aspects of what you are volunteering for.
Obligaitions and costs
Clinical trials offer medicines at near-free levels, a significant benefit. However, there are obligations that fall on the patient. First, the financial. Not ALL costs are covered; typical/usual costs incurred with treating your disease (i.e. a regular trip to the oncologist) is usually billed to your insurance, with the patient being responsible for their normal contributions.
The other obligation is your time and commitment. As mentioned above, you may opt-out of a trial at any time, but as long as you remain in trial, you are bound by the schedule laid out in the protocol and informed consent. There will likely be scheduled tests done (scans, blood draws, and other measures of health) in addition to the treatment given. That obligation comes with benefits on top of the medicine – your condition well-monitored and are interacting with your medical team on a frequent basis.
Being on a clinical trial is an experience unlike any other. The fear of the unknown is understandable, but is balanced by the opportunity to both improve your own health, and give others that same chance by being a pioneer in the medical world. The next time you or someone you love has a disease, health condition, or addiction to address with treatment, remember that without trials, there is no medicine, and without participants, there are no trials.
Have you taken our In America survey yet?