What are clinical trials — and why should I consider them?
Clinical trials are a very important part of cancer research. Trials can also benefit individual patients, although that is not their primary purpose.
For researchers and scientists, clinical trials are key to learning about new and more effective ways of preventing, diagnosing, and treating cancer.
For patients, clinical trials can be a great opportunity to get access to upcoming treatment options. It’s important to know that all patients at any stage or type of disease can consider clinical trials at any point — even early or late-stage patients.
Want to learn more about clinical trials?
A good place to start is this useful introduction to colorectal cancer clinical trials from our partners at FightCRC.
Common clinical trial questions are answered in these short videos from the American Society of Clinical Oncology and this guide from the National Institute of Health (NIH).
Why should I take part in a trial?
Clinical trials can help you reach your goals, whatever they may be. Take some time to think about what your personal goals are — whether it’s a better quality of life, more time to spend with family, a break from chemo, disease stability, or something else. It’s important to think about what trials can offer you that standard-of-care (SOC) treatment cannot. Knowing what you want out of a trial can help guide your decisions, and figure out which trials are right for you.
When you participate in a clinical trial, you help researchers learn more about new treatments and medical advances. Many trials also give you access to innovative medications or treatment plans that may not be available as part of the standard-of-care. For colorectal cancer, there are very few lines of treatment that are currently approved for use. If a patient’s cancer continues to grow while on these lines of treatment, they may run out of options for controlling their cancer. Participating in a trial can provide access to experimental treatments and expand the options available to them.
You will also have frequent check-ups throughout the trial process, which can give you confidence that you and your disease are being carefully monitored.
Are trials a good option for me?
While many people think of clinical trials as a last resort, this is not true. Doctors want to use standard-of-care treatment plans first — outlined in the NCCN guidelines here — because these treatments are well-researched and the risks are known.
However, there are many trials open to patients from all stages and points in their cancer journeys. There are even trials for patients who have not yet started any treatments (called first-line trials) and for patients who are currently NED (no evidence of disease status).
There are also many different types of clinical trials. We focus on interventional trials (trials that have to do with treatment) in this section, but not all trials include treatment. Read more about different trial types here.
Trials also have different phases, which focus on different research goals. Different phases come with different risks and benefits associated with them. For example, phase I and phase II trials may have more experimental treatments than phase III trials. So it is possible to find a trial that aligns with your risk tolerance and goals at the moment. Read more about trial phases here.
Therefore, it’s a good idea to research your trial options at many points during your treatment journey — even if you don’t find anything suitable for you, or if you decide not to participate.
Watch this video from the National Cancer Institute:
What are the potential benefits?
The greatest benefit of participating in a clinical trial is the opportunity to access innovative medications and treatment plans before they are approved for general use. For some people, these treatments may significantly improve quality of life, help manage disease long-term, provide a break from chemo, or help them reach their other goals. If you are a stage IV patient, you will likely have to make options for yourself, and clinical trials can be a key part of your treatment plan.
In addition, clinical trials may include testing, surveillance and monitoring beyond standard-of-care, as well as long-term follow-up with trial researchers. You are also helping researchers learn how to better treat your disease, helping future patients just like you.
What are the potential drawbacks?
Clinical trial treatments have not been tested for safety and efficacy the same way that standard-of-care treatments have. That doesn’t mean that they are dangerous — this means that the risks associated with participating in a trial are unknown, and may include unpleasant, unwanted, or in rare cases, life-threatening side effects.
Depending on where the trial is located, participating in a trial may also involve a greater commitment to traveling. You may also have more monitoring appointments (scans, blood draws, and other monitoring tests). You should think about how these requirements fit into your life and your goals.
The most important drawback is the risk that the trial drug or treatment will not work very well for you or may not work at all. If the main reason you sign up for a trial is in hopes that the treatment will make your tumors stop growing, then the fact that they may not stop growing is the biggest risk. With standard-of-care chemo, we already know that a vast majority of people will have some response to treatment. However, it is also important to remember that standard-of-care treatment may not work well for you either.
Depending on the type of trial, enrolling in some trials can disqualify you from future trials. Before enrolling in a trial, it’s very important that you make sure you understand all the potential risks involved, and what the research team is doing to help mitigate those risks. For questions to ask before deciding to participate in a trial, see our list of questions here.
What else should I consider?
In general, patients do not have to pay out of pocket to participate in a clinical trial. The trial sponsor will usually cover all costs directly related to the trial. These costs include the trial drug or treatment, extra doctor’s visits associated with the trial, diagnostic tests, and monitoring scans directly related to the trial, but this can vary from trial to trial. Make sure to discuss this topic with the trial coordinator before you start.
However, patients will often be expected to pay for costs related to their regular cancer treatment. These costs could include routine blood tests, scans, imaging and doctor’s visits. Luckily, these things should be covered by your insurance — although you will have to continue to meet your regular deductibles and co-pays. It’s important to note that costs covered by insurance will adhere to your plan’s benefits. So if a trial site is out-of-network, it will be billed to you as out-of network.
If your clinical trial requires traveling, you may have additional expenses. Depending on how far you have to travel, how frequently your appointments are, and how much time you need to spend at the trial site, costs can add up.
Luckily, trial sponsors may offer travel vouchers to help cover some of these expenses. If not, Lazarex Cancer Foundation has a financial assistance program to help patients cover travel and accommodation expenses associated with participating in a clinical trial. In addition, trials at NIH cancer centers cover travel expenses.
Before joining a trial, you should receive detailed information about the costs that will be covered by the trial sponsor and the costs that will be billed to your insurance. Make sure you understand this information to avoid surprises later! If you have questions, or if something isn’t clear, don’t be shy to speak up and ask. If you are unsure if your insurance will cover something, contact your insurance company to ask.
Want to learn more about paying for clinical trials?
How are patients kept safe?
Potential treatments are thoroughly tested for safety and toxicity in the laboratory and in animals before being approved for human trials. Placebos are very uncommon in cancer trials. Researchers take many precautions to ensure the safety of trial participants.
First of all, there are strict eligibility criteria to make sure that participants are healthy enough to tolerate potential risks and side effects.
Patients are also briefed on all potential risks and benefits of the trial, and must then sign a consent form to show they understand this information.
Finally, throughout the trial, researchers conduct extensive monitoring of patient health and quality of life. This helps them intervene quickly if anyone experiences severe side effects. Before starting a trial, you should be given information on what monitoring and safety measures are in place. If not, ask!
How to make clinical trials work for you
All medical treatments have possible risks and benefits, including clinical trials. These risks and benefits can vary depending on the type of treatment and how much the treatment has been researched. There is also a misconception that standard-of-care (SOC) cancer treatment is not risky, but that isn’t true. The difference between SOC and clinical trials is that the SOC risks are known, and clinical trial risks may be unknown. For example, SOC may include the risk of overtreatment for some early-stage cancer patients.
Therefore it’s important to understand your own risk tolerance, which depends on your personality, medical history, family circumstances and personal goals. You should understand these factors before starting a trial so you can make a well-informed decision about participating.
Everyone will react to a trial differently. Therefore it is impossible to guarantee how well a specific trial will work for you and how well it will help you achieve your personal goals.
However, by doing your research in advance, you can increase your chances of having good trial options ready when you need them and having a good response to a clinical trial. A good first step is participating in clinical trial discussions in COLONTOWN neighborhoods.
Thanks to precision medicine and genomic profiling, researchers are getting better and better at identifying which patients are most likely to respond to particular drugs. There may be trials available specifically targeting a mutation you have.
Be sure to keep in mind that shrinkage is not the only goal. Disease stability can also be of great benefit to many patients. Think about your own personal goals, chat with your doctor about options, and join COLONTOWN to help maximize your clinical trial options.
Curious about clinical trials?
Join one of our COLONTOWN Facebook groups:
- In Tom’s MSI-H Clinic, we discuss treatments and trials for MSI-H patients
- In Tom’s MSS Clinical Trials, we chat about trials open to mSS patients
- In Tom’s NIH Lounge, we discuss trials run by the National Institute of Health (NIH)
Want to join? Fill out the registration form here.
COLONTOWN University has so much more to offer, from DocTalk videos with CRC experts to easy-to-understand explanations of biomarker tests. We’re here for you! See our list of Learning Centers here.