Answers to Common Concerns During a Clinical Trial

It’s always important to get all your questions clarified before you start a clinical trial.

“Information is the resolution of uncertainty.”

- Claude Shannon

A cancer clinical trial can be a treatment option for anyone who has received a cancer diagnosis regardless of the stage or type of cancer. Most patients have questions and concerns if they’re thinking about participating in a clinical trial beginning with:

“Are cancer clinical trials safe?”

Clinical trials are one of the safest environments for testing new drugs. When you are in a clinical trial, you’re often being watched more closely than if you were receiving the standard-of-care treatment. You not only have the supervision of your physician, but also of the entire clinical trial research team. They constantly check on every side effect you may experience, monitor your lab results and follow up on any issues you might be having, all of which provide a necessary level of reassurance and improve your quality of life during treatment.

“How will participating in a trial benefit me?”

Clinical trials allow patients to get access to drugs and new treatment modalities that may not be available otherwise for many years, including the possibility of being treated with a drug that’s more personalized and effective for a particular cancer type.

“Will being part of a trial change my day-to-day life?

Being in a clinical trial will affect schedules and it is important that you understand what your commitment is going to be if you agree to enroll in a clinical trial. Here are some questions to consider:

  • You might need to go in for an exam or testing at specific times and often. Is this something you’re going to be able to manage, especially if you’re juggling work, home and childcare at the same time?

  • Do you have a support system to help with additional appointments and testing?

  • Will you be able to keep a diary to record trial-related information as is the case in some trials?

  • Would you be available for regular calls from someone from the research team during treatment for monitoring the side effects?

  • If you experience any side effects, you may need to report them immediately and get yourself checked. Would you be able to drop everything and go to the clinic?

Of course, if you agree to participate, always remember, you always have the option to drop out of a trial for any reason at any time.

“How much will the trial cost me?”

Another common concern is the question of the cost of a clinical trial. Most clinical trials cover the costs of care beyond the standard-of-care patients are responsible for. For example, your medical insurance will be billed for exams, labs or scans that are part of your standard treatment program, but anything extra that’s related to the trial is covered by the trial itself. This includes additional blood work or scans as well as genetic studies and biomarkers. Who is responsible for what costs is outlined clearly in the informed consent document, which is another reason you should carefully read the document before signing it.

It is sad that in the US, less than 5% of cancer patients ever enroll in a clinical trial, and hundreds of clinical trials never get off the ground because of lack of patient enrollment.

The problem isn’t the lack of available trials or lack of patients with cancer, but that patients either are not aware of the trials or they are not aware of them at the right time. Clinical trials have very specific eligibility criteria, and sometimes the window for enrolling is narrow. Also, not all oncologists and cancer centers offer clinical trials. The best way to find a clinical trial that is right for you is to talk to your healthcare team. If your provider does not talk to you about clinical trials, you should ask if they offer clinical trials or can refer you to one. If the answer is no, you may want to get a second opinion from a cancer specialist who does. Getting a second opinion can help you learn more and feel confident about your treatment decisions.

Participating in a cancer clinical trial can sometimes be overwhelming but you can be rest assured that there are enough safety measures built in to make sure that you are receiving the best care possible.

Be sure to speak to your support team in detail and address all your concerns before considering a decision.

Here are additional questions that can help you decide on a clinical trial:

Will the trial drug make me feel worse or hurt more than I currently feel?

  • Will the treatment be worse than the disease?

  • Will participation be an additional burden on top of what I’m already going through?

  • Are there many trials available for the type of cancer I have?

  • How do I decide which trial is the best for me?

  • What are the possible benefits of this trial?

  • What side effects might I experience?

  • Have any other trials been done with this drug/treatment on people with the type of cancer that I have?

  • Will I know if I’m getting the trial drug or standard-of-care treatment?

  • Are there any biomarkers I should be tested for? Could that help me qualify for personalized clinical trials or therapies?

To make it easier for you to address all your concerns, please take a look at the Cancer Trial Checklist before you go to meet your doctor or care team regarding enrolling in a clinical trial.

"There's always hope beyond what you see." - Cora Connor, kidney cancer caregiver.

Your participation in clinical trials is an opportunity to help future cancer patients and contribute to research as well as a way to be involved in the frontlines of research to advance cancer care for everyone.

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There is new research from Brigham and Women’s Hospital that indicates a Western-style diet that is rich in red and processed meat, sugar and refined grains/carbohydrates is tied to higher risk of colorectal cancer through the intestinal microbiota.  Gastroenterology, 2022;DOI:10.1053/j.gastro.2022.06.054