Clinical trials are essential to advancing cancer treatment. They help researchers discover new therapies, improve existing options, and offer patients access to the latest innovations in care. Whether you’re newly diagnosed, in active treatment, or managing advanced disease, clinical trials can be pursued at any stage. Your care team may recommend a clinical trial based on your health, cancer stage, and overall treatment goals.
In honor of Clinical Trials Day (May 20th), we’re here to break down clinical trials and how they could potentially work for you.
Who can participate in a clinical trial?
Every study has its own requirements that can qualify or disqualify you from a trial. The eligibility criteria can include factors like age, ethnicity, previous treatments, and genetic mutations. You can ask your care team if you qualify for a clinical research trial or visit clinicaltrials.gov to see a list of studies that you’re eligible for. The Outcomes4Me app can also help you find a relevant clinical trial.
Misconceptions about clinical trials
Confusion and misconceptions about clinical trials can make some patients hesitant to participate in clinical research. Being a “guinea pig,” financial toxicity, and receiving a placebo treatment are examples of some myths surrounding clinical trials. Clinical trials are closely monitored and follow rigorous regulations, which is why they often take years to complete.
Before enrolling, you’ll go through an informed consent process where you’re given detailed information about the trial’s purpose, potential risks and benefits, and your rights. Participation is always voluntary, and you can choose to leave a trial at any time. Understanding how clinical trials are designed and overseen can help clear up these myths and make the decision to participate less intimidating.
What are the different types of clinical trials?
A clinical trial can be used to detect and diagnose disease, measure the phase of the disease, and test new drugs and treatments.
Types of clinical trials include:
- Pre-clinical studies, or laboratory studies, are done first to examine a new treatment’s initial effect on cancer cells living in a lab or test tube. Lab studies can also include testing on animals to see how the drug might affect a living being.
- An investigational new drug application (IND) is a request sent to the FDA asking for permission to test the drug on humans. This application outlines the pre-clinical study findings and provides additional details on the clinical trial and drug.
- Phase 0 clinical trials employ a small sample size of around 15 people and provide them with a very small dose of the drug. Phase 0 isn’t required, but it’s usually done to get initial feedback on how the drug works.
- Phase I clinical trials examine side effects, dosages, and how to best deliver the drug. The participant pool for this phase is still relatively small and close monitoring for safety is a top priority.
- Phase II clinical trials follow the learnings of Phase I. If Phase I has shown promising results, more participants are recruited to explore the drug in a specific type of cancer.
- Phase III clinical trials are the last phase before submission for FDA approval. This step examines if the new drug is more effective than the standard treatment and usually follows a randomized approach. Phase III trials can include up to several hundred participants.
- Phase IV clinical trials occur after a new drug application is received and approved by the FDA. As more patients receive the new drug, these trials serve to monitor progress, safety over time, quality of life, and cost to the patient.
What’s Clinical Trials Day?
On May 20th each year, clinical research and clinical trial professionals from all over the world are honored for the work they do to advance cancer research. Clinical Trials Day acknowledges the contributions made by those who conduct, manage, and participate in clinical trials. The day also serves as an opportunity to raise awareness about the importance of clinical trials in advancing cancer care and to educate the public about how they can get involved in research that may lead to breakthroughs in treatment.
How can you support clinical trials?
Supporting clinical trials can take many forms. One of the most direct ways is by participating in a trial if you’re eligible. There are also opportunities to participate as a healthy volunteer. If you are not eligible or ready to participate, you can still support clinical trials by spreading awareness about their importance, encouraging others to consider participation, and advocating for increased funding, diversity, and resources for clinical research.
What clinical trial resources are available to me?
- NIH (National Cancer Institute) Find a Clinical Trial (includes a live chat option)
- NIH’s Steps to Find a Clinical helps you get organized before talking to your care team
- National Library of Medicine clinical trial finder
- Call 1-800-4 CANCER (1-800-422-6237) to talk to a clinical trial specialist
- Visit American Cancer Society Access to Clinical Trials and Support
- National Comprehensive Cancer Network (NCCN) offers literature in 7 languages
As always, if you would like to connect with an Outcomes4Me oncology nurse practitioner at no charge through the Outcomes4Me app, just use the “Ask Outcomes4Me” button.
