Colorectal Cancer Clinical Trials

If you have ever taken a pill or been treated for an illness, you’ve experienced the benefits of clinical trials firsthand.

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Clinical trials are the beating heart in the fight against colorectal cancer. They are vital, but they seem complicated and frightening. Our Clinical Trials brochure outlines what a clinical trial is; who clinical trials are for; and so much more.

Our original 3-part publication for stage III and IV survivors and their loved ones. Everything you need from diagnosis to survivorship.

Inspired by the late Dr. Tom Marsilje, scientist and stage IV colorectal cancer patient, this tool is curated by our team to help you find trials.

Read the Fight CRC blog for the latest in colorectal cancer clinical trials. We break things down to make it as simple as possible.

About Clinical Trials

Clinical Trials Are Research Studies.

The goal of clinical trials is to make cancer treatment better so people can live longer. Researchers and doctors follow strict guidelines to protect trial participants while collecting information to assess medical protocols, treatments, medical devices, and more. They do this to learn if they work and if they are safe. Clinical trials are done for many diseases – including colorectal cancer (CRC) – and within different groups of people (age, ethnicity, sex). Before new drugs reach patients enrolled in clinical trials, they go through a rigorous testing process. For CRC, clinical trials provide information on new, innovative ways to treat the disease. Without them, CRC therapies would not evolve to become better and more reliable. All current therapies used today are a result of clinical trials!

As the world looks toward a future without cancer, many are working hard to learn about the disease: How it works, how to best treat it, how to detect it, and how to make those who have it live longer and with more comfort. This work is most successful when teams of patients and researchers come together in clinical trials – a necessary step to achieving a world without cancer.

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Before new drugs reach patients enrolled in clinical trials, they go through a rigorous testing process. 

Terms to Know

  • Standard of Care: Also called best practice, this is a leading treatment protocol used by medical professionals to treat a certain disease.
  • Protocol: A detailed plan that describes the steps of a clinical trial or treatment. The protocol outlines how the clinical trial will be executed. Based on the requirements of the protocol, you may or may not qualify for a specific clinical trial. If you qualify for the clinical trial, you will be asked to agree in writing to follow the protocol. This is called giving informed consent. 
  • Informed Consent: The process which a person is informed of the purpose, methods, and risks of a procedure, and then agrees to receive treatment. The informed consent outlines what you are committing to. Even if you sign it and you decide to change your mind, you have that right because you are always in control of your health care. You can withdraw from the clinical trial at any time. Clinical trials are done for many diseases – including colorectal cancer – and within different groups of people (age, ethnicity, sex). 

What to Know Before Enrolling

Before you enroll in a clinical trial, it is a good idea to learn as much as you can about it. You may be interested to know that there are different kinds of clinical trials. Some need healthy volunteers, while other clinical trials seek volunteers needing treatment. Researchers may be recruiting patients of a certain age, with a tumor in a specific location or who have a certain genetic mutation.

A clinical trial’s protocol describes: 

  • What types of volunteers may enter the study 
  • The schedules of tests and procedures, study medications, and dosages 
  • Length of the study 
  • Number of study visits

Based on the requirements of the protocol, you may or may not qualify for a specific clinical trial. 

Clinical Trial Participation Is Voluntary

You can withdraw from the trial at any time, if you choose to do so.

Types of Clinical Trials

  • Treatment trials test new drugs and treatment protocols
  • Prevention trials look for new and innovative ways to prevent cancer and/or cancer recurrence
  • Screening trials identify the best ways to screen for cancer, and develop new ways to screen for cancer (think colonoscopy)
  • Adjuvant trials are done right after primary treatment to reduce the chances of cancer coming back or spreading after primary treatment
  • Neoadjuvant trials are done right before primary treatment to reduce the chances of cancer coming back or spreading after primary treatment
  • Single agent trials test only one drug
  • Combination trials test multiple (more than one) drugs being used together
  • Quality of life / supportive care trials discover ways to make patients more comfortable during treatment and with fewer side effects
  • Diagnostic trials attempt to improve the way tests identify whether or not a person has cancer

Questions to Ask Your Healthcare Team

  1. What is the purpose of this clinical trial?
  2. Why do researchers think this treatment might work for me?
  3. What are my treatment options?
  4. How will this clinical trial help me, my family, or my community? 
  5. What will I be asked to do? 
  6. How long is the clinical trial going to last? 
  7. What are the possible risks? 
  8. Will I have to pay for any part of the clinical trial?
  9. Will I be reimbursed for costs of travel, parking, or meals incurred while I am in a clinical trial? 
  10. If the treatment works for me, can I keep using it after the clinical trial ends? 
  11. How will this study affect my daily life? 
  12. Will anyone else know about my participation?
  13. Am I eligible for a clinical trial? If yes, do you feel that would be a good choice for me?
  14. How do the possible risks and benefits of the new treatment compare with my other treatment options?
  15. Are there extra procedures or visits in the trial compared with standard care?
  16. Who will pay for what in the trial?
  17. What is the standard treatment for someone in my situation? What do you recommend?
  18. What will my treatment schedule look like?
  19. What are the short- and long-term side effects of the treatment you are recommending?
  20. How will my health be monitored during treatment?

It’s OK To Be Nervous. Here Are Some Risks To Consider.

Protecting clinical trial patients is the most important part of a trial – after all, clinical trials are done to improve cancer treatment. However, some trials test new drugs with unknown side effects and reactions. Even drugs used for many years cause severe or life-threatening side effects in some people.

Clinical trials are for people who want to move science forward and want to find a treatment beyond the current colorectal cancer therapies. Most people do experience an element of fear when signing the forms for a clinical trial because they’re moving into an unknown area that has risks.

There have been many successful trials; however, there is no guarantee all trials will be successful. Trial procedures are reviewed by researchers, their peers, Institutional Review Boards (IRBs), patient advocates, the National Cancer Institute (NCI), the FDA, and more to ensure patient safety.

Even with all the dedicated review, there are still risks. Here are some considerations:

  • New treatments aren’t always better than the standard treatment available. In some situations, they may be less effective.
  • There may be unexpected side effects, or side effects may be worse than the standard treatment.
  • Patients in RCTs can’t choose their treatment, nor can their doctors.
  • Some clinical trial costs may not be covered. Check with your insurance company to learn more about potential costs.
  • If the trial requires you to travel, consider additional challenges that may result. For example, costs of hotels, drive or flight time, time spent away from home, etc.

Call your insurance to make sure you know what will and won’t be covered when joining a trials. You should also speak directly with the trial team about costs associated with the trial.


“Take a deep breath and compare your treatment options using data to guide your decision. For example, right now there is an experimental therapy with preliminary higher response rates than multiple FDA-approved therapies for CRC. So an experimental therapy does not automatically mean a lower quality therapy than FDA-approved options. Being an experimental therapy just means it has been taken by fewer patients, so less is known about its safety & efficacy profile.”

-Tom Marsilje, Ph.D. | Stage IV

Diversity and Health Equity in Clinical Trials

Representation Matters

People who are underrepresented in health care are generally likely to also be underrepresented in clinical research. Fight CRC works in step with the patient community to discover new ways to improve and extend lives by addressing these issues.

The three objectives for continuing to address education, awareness, and representation in clinical trials include:
  • Develop tools and opportunities to connect the research community, research advocates, and patients.
  • Create tailored, culturally sensitive resources to disseminate to Hispanic, Black, and Indigenous communities.
  • Expand on Fight CRC’s Research Advocacy Training and Support (RATS) program to include a culturally competent curriculum; utilize updated curriculum to train diverse research advocates for clinical trial navigation.

Improving representation and enrollment in cancer clinical trials is important not only to ensure generalizability of the results but also to provide an opportunity to study cancer biology and response to therapies across different patients’ subgroups. This will provide an opportunity to study therapeutic responses across different socio demographic groups. Differences in biologic responses may result in increased resistance to some medications.1,2 

Progress is Being Made

For many years, clinical trials were done on white men only: Groups such as women and minorities were not included. But today, clinical trials welcome the participation of all people, and these clinical trials are closely monitored to ensure safety for the patient and ethical treatment of all patients who participate.

Race, Ethnicity, and Clinical Trials

According to the U.S. Census Bureau, Non-Hispanic Whites represent 60.1% of the U.S. population, Hispanic/Latinos represent 18.5%, and Black/African Americans represent 13.4%. Yet, according to the FDA 2020 Drug Trial Snapshots, on average, Non-Hispanic Whites comprise 75% of traditional trial participants, while Hispanic/Latinos comprise only 11% and Black/African Americans comprise only 8% of participants.

Black americans

  • Are the second largest minority population in the United States, following the Hispanic/Latino population. Each year, thousands of Black Americans take part in clinical trials to help find ways to prevent, treat, and cure illness. Clinical trials help Black Americans and all people enjoy better health.

Hispanic americans

  • While minorities make up 30% of enrollees in National Institutes of Health (NIH) clinical trials, Hispanics make up 7.6% of participants, compared to 15% of Black Americans, according to NIH.

Asian americans

  • Advancing the health equity agenda for Asian Americans, Native Hawaiians, and Pacific Islanders has become an intersecting priority for federal agencies. But, a cross-sectional study found that 529 clinical research projects focused on Asian Americans, Native Hawaiians, and Pacific Islanders funded by the NIH between 1992 and 2018, composing 0.17% of the total NIH budget. This proportion of the total NIH budget has only increased from 0.12% before 2000 to 0.18% after 2000.

JAMA Netw Open. 2019;2(7):e197432. doi:10.1001/jamanetworkopen.2019.7432

Indigenous communities

  • In 2021, the first study was published to provide data about inclusion of American Indians/Alaska Natives in NIH-IRP clinical studies. Data was analyzed from the more than 1,800 NIH-IRP protocols active in 2014 and 2017. It was found that the absolute number of American Indian/Alaska Native enrollees increased between 2014 and 2017 but remained at 1% of all participants, a disproportionately low level.

“As a person of color, I view myself as being different; because of these differences, my responses to various medications may not be the same. Therefore, it is critical to public health that we understand the importance of diversity in clinical trials. A program that aims to improve this, such as Fight CRC’s, would be beneficial and ensure patients of color who use new treatments have results that are widely applicable to help fight illnesses and possibly save my life in the future.”

-Wenora Johnson | Stage III

“The more, and the more diverse, people that participate in clinical trials, the sooner there will be better, specific treatments and prevention resources for CRC patients.”

-Maia Walker, Fight CRC Clinical Trial Finder Curator

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