Clinical trials are performed to test new medications, procedures, protocols, interventions, and devices to see if they are safe and effective. They are performed for many diseases within different groups of people (age, ethnicity, sex).

Clinical trials may also be performed with the goal of addressing side effects secondary to a primary illness, such as cachexia or skin toxicity, that may accompany cancer treatments. They may be performed to see if a new treatment option is safer or more effective than an existing option. Clinical trials also address quality of life and symptom management, genetics and personalized medicine, and survivorship and long-term outcomes.

Clinical trials are for anyone who meets the eligibility criteria of the trial.

You don’t have to have stage IV cancer or exhaust all treatment options in order to participate in clinical trials. If you meet the specific eligibility criteria of a trial, and the trial is still recruiting, then that trial may be for you!

For patients interested in treatment trials, it is critically important to understand your diagnosis. Knowing the stage of your disease, your biomarkers, specific cancer type (colon vs. rectal, or left vs. right side), and previous therapies you’ve received are all crucial information to have when looking for a trial.

If you’re unsure of this information, have a conversation with your care team.

Looking for a doctor who performs clinical trials?

Clinical trials test the efficacy and safety of new drugs, drug combinations, non-drug treatments, surgical techniques, medical devices, and interventions like the impact of diet and exercise on the prevention of cancer.

In treatment trials, clinical trials are designed to test how well the study protocol works (their efficacy); how their efficacy compares to the current standard of care (the treatment you’re likely already getting); and their safety profile, which is essentially a drug’s likelihood of causing side effects at a given dose.

Clinical trials are all tested in a rigorous process that proceeds in phases, from preclinical studies to large trials in broad groups of patients. Clinical trials may test through four phases, but not all treatments and therapies advance through all phases, and not all treatments and therapies are approved after proceeding through trials.

In fact, only about 1 in 5 new drugs that enter clinical trials are eventually approved by the FDA.

On average, it takes about eight years for a new drug to get through clinical trials. Trials are conducted methodically, with the safety of participants being top priority.

There are several ways to find a trial that you are eligible for

There are several steps to take when you’re interested in enrolling in a clinical trial. After you’ve talked with your healthcare team and find agreement that the trial could be a good option for you, this is likely what comes next:

Most likely, and especially if the trial involves drug development, you’ll need to collect your medical records. The specifics of what you’ll need will be dictated by the trial protocol.

• Cancer specifics:  If you’re enrolling in a clinical trial for patients, you’ll need to know the stage of your cancer, along with specifics relating to your tumor’s location (right side vs. left side) and type (colon vs. rectal).
• Current therapies: Know which therapies you are currently receiving, if applicable, and which therapies you have tried in the past. Eligibility for treatment trials requires you to have used specific treatments in the past, or alternatively, require that you have not used certain therapies previously.
• Biomarker status: Patients need to know as much information as possible about their unique biomarkers.
• Previous Imaging: You will need to collect any imaging (scans) that has been performed. You may need both the interpretation by a radiologist (commonly referred to as “the read”), and the actual imaging studies, normally provided on a CD or transferred electronically, if possible.
• Ask about costs: There may be costs associated with obtaining your medical records, and it may take some time to get everything you need, so be diligent. These are your records, and you have a right to them!

You can also reach out to the researchers conducting the trial directly. They should be able to help you understand whether you qualify, and they can assist you when it comes time to enroll in the trial.

Contact details and location information for trials are generally easily found in the trial listing, making it easy to reach out to the study’s organizers to ask questions or get enrollment information.

The actual trial will most likely be free for you to participate in (as of 2014, the Affordable Care Act requires that most private insurance cover routine costs for approved clinical trials), but there may be other costs associated with participation that are not so obvious. Be sure to consider these potential hurdles when enrolling in a trial:

Each clinical trial is unique. The details of what you will be doing; which drugs or interventions you will receive; if/how often you are required to attend clinic; and many other factors will be unique to the trial you are participating in and are dictated by the protocol of the trial.

If you’re enrolled in a trial for drug development, generally, you will be required to spend time with the study team which can include:

• The investigators conducting the study
• The study coordinator
• Any staff who work at the study site, such as nurses and technicians.

You’ll be able to answer their questions and submit to any diagnostic testing required during the trial, such as lab work or imaging. Your general care will most likely be handled by the study team during the duration of the trial, but this may vary on a case-by-case basis.

You may encounter some unfamiliar terms while searching for a clinical trial. Here are quick definitions:

Also called “best practice,” this is a leading treatment protocol used by medical professionals to treat a certain disease.

A detailed plan that describes the steps of a clinical trial or treatment.

A patient is informed about the methods and risks of a procedure and agrees to receive treatment yet can withdrawal at any time.

Trial participants are assigned to a specific arm of the study to balance differences in participants, such as age and sex.

A group of patients receiving a specific treatment; typically trials have at least two arms, sometimes more.

For years, clinical trials were primarily run on white men only: Groups such as women and minorities were either not included and/or participants were harmed in the process. Fortunately, this has changed, and today, trials encourage and actively seek out the participation and safety of all eligible people.

Informed consent is essential to any participant, and trials are heavily overseen by ethics groups and review boards.

However, clinical trial enrollment in the United States is generally low, and enrollment statistics do not align with the demographics of the United States.

For instance, between 2015 and 2021, the Food and Drug Administration (FDA) approved 82 new therapies for cancer treatment. Nearly 90% of the clinical trials that supported the approval of these therapies lacked adequate representation of Black patients, and 73% lacked adequate representation of Hispanic/Latino patients.

Low diversity in clinical trials means that the participant population does not accurately reflect the real-world population of those with cancer that might need these new therapies.

Racial groups may respond differently to drugs and other therapies, so ensuring diversity within clinical trials ensures that new treatments work for everyone.

There is a role for people of all backgrounds in clinical trials, and the more diverse people that participate, the sooner there will be better screening resources and treatment options for all colorectal cancer patients.