How Do Cancer Clinical Trials Work, and Who Qualifies to Participate?

Key Takeaways

• Cancer clinical trials are research studies that test new ways to prevent, identify, and treat cancer. They are carefully designed to protect patient safety and meet ethical standards.
• Clinical trials aren’t just a last-resort approach; they are a way to have access to innovative new therapies that patients otherwise wouldn’t be able to receive.
• The benefits of clinical trials go beyond access to innovative therapies to advancing cancer research, having close medical supervision, and, often, not having to pay for the treatment.
• To determine your suitability for a clinical trial, talk with an RCCA oncologist or search the RCCA clinical trial database for relevant clinical trials to see if you meet the eligibility criteria for a particular study.
• Regional Cancer Care Associates offers access to hundreds of clinical trials, including studies focused on prevention, diagnosis, and treatment.

What Is a Cancer Clinical Trial?

Clinical trials for cancer are research studies that test new methods of preventing, detecting, or treating cancer. These studies help determine if these new techniques are safe and effective. If they are, the techniques often become innovative new tools used in cancer prevention, diagnosis, and treatment.

The Phases of Clinical Trials

There are four main types, or phases, of clinical trials:

• Phase I: These trials test a new treatment on a small group of people, typically 20 to 100. The study participants may be healthy volunteers, or they may be people who have been diagnosed with the disease that the investigational therapy is designed to treat. The purpose of Phase I trials is to assess the safety of a treatment and determine the dosage to be evaluated in later trials.
• Phase II: In Phase II trials, the investigational agent is administered to a larger group of people, all of whom have the disease that the drug is intended to treat. In these studies, which may enroll 100 to 300 people, participants usually are assigned at random to receive either the investigational medication or a comparator, which may be either another medication already approved to treat the disease or a placebo (although placebo-only study arms are not used in cancer trials).While safety remains a key focus of Phase II trials, the main outcome studied – known as the primary endpoint – typically is a measure of the treatment’s efficacy, such as its impact on overall survival. .
• Phase III: Several hundred to a few thousand people typically participate in Phase III trials, which are conducted to evaluate the efficacy and safety of a treatment in a large population. Regulatory authorities such as the Food and Drug Administration (FDA) give particular attention to the results of Phase III trials when deciding whether to approve a therapy.
• Phase IV: These are post-approval trials conducted to monitor the safety and effectiveness of a therapy after physicians have begun prescribing it to their patients. A major focus of Phase IV studies is to ensure that no new safety signals emerge once a therapy is used in a broader population. For example, the Phase III study that led to a medication’s approval may not have enrolled people over age 60. In Phase IV studies, data on outcomes on people in their sixties and beyond can be collected and assessed.

Who Sponsors Clinical Trials?

Clinical trials typically are sponsored by a company, institution, or organization that initiates, oversees, and funds the study. Common sponsors include:

• Pharmaceutical or medical device companies
• Academic medical centers, such as universities or hospitals
• Government agencies or non-profit organizations, such as the National Cancer Institute (NCI) or a patient advocacy group focused on a particular type of cancer.

Although sponsors manage and finance the trials, they don’t typically conduct the research themselves. Rather, they delegate the duties to researchers at clinical trial sites.

Why You Should Consider a Cancer Research Trial – And Not Just as a Last Resort

Many people with cancer have the misconception that clinical trials are a last resort to be considered only after all approved therapies have failed. Although it is true that many patients turn to clinical trials after trying other treatments, many patients use clinical trials as an early intervention, even as their first treatment. That’s because clinical trials provide access to cutting-edge therapies that may work better or have fewer side effects than traditional treatments.

Clinical trials are also how every cancer treatment available today was developed, which means that participation in a trial can help benefit cancer research – and people with cancer — for years to come.

Other potential benefits for trial participants include:

• Close monitoring to manage side effects, if they occur
• Frequent contact with your care team to ask questions or discuss concerns
• No cost for experimental treatment (in most trials)

People who benefit the most from clinical trials often include patients who have received prior treatment (relapsed/refractory disease), newly diagnosed patients who may benefit from frontline trial regimens, and patients with rare cancers or molecular subtypes with few approved options.

Addressing the Biggest Fears About Clinical Trials

Some people have misconceptions or fears about participating in clinical trials. They include:

• Will I be a guinea pig?: Although trials are used to test new treatments, they have strict safety protocols and ethical rules to protect the participants. Also, participants can leave the trial at any time.
• What if I get placebo?: Although placebos may be used in some clinical trials evaluating therapies for other, less-serious diseases, placebo-only groups are basically non-existent in cancer trials. As a rule, participants are assigned at random to receive either the treatment being evaluated or another, already approved therapy. In trials investigating use of a new therapy in combination with an already approved treatment, cancer trials often do test the two-drug combination against the approved drug plus placebo, but patients in both groups are receiving medication.  
• Does joining a trial mean my doctor has given up on me?: No! Some patients think that the recommendation of a clinical trial means their doctor has given up on trying to treat their disease. The opposite is true. Participation in a clinical trial can provide access to potentially life-saving interventions that patients otherwise wouldn’t be able to receive.

If you have concerns about participating in a clinical trial, ask your oncologist any other specific questions you may have.

What Are the Types of Clinical Trials Offered at RCCA?

At RCCA, we participate in hundreds of clinical trials. The types of trials we offer include:

• Treatment trials: These studies involve testing new drugs, drug combinations, surgical procedures, or medical devices to treat cancer. These are the most common types of trials offered at RCCA.
• Prevention trials: These trials often use methods like vaccines, medicines, or lifestyle changes to prevent cancer from occurring or recurring.
• Screening/diagnostic trials: These trials test new methods for detecting cancer early, often before symptoms appear. They may also compare different tests or procedures to determine the best way to diagnose a specific cancer.
• Quality-of-life trials: Also known as supportive care trials, these trials assess different methods of improving the physical or mental health, comfort, and overall well-being of patients with cancer.
• Biomarker and genomic trials: These trials test the efficacy of medicines tailored to specific DNA changes, rather than just the location of the cancer.

Whether you’re looking to participate in a treatment trial, a quality-of-life trial, or another type of study, you have options at RCCA. Ask your oncologist about whether you may be a candidate.

How Do You Find Out If You Qualify for a Clinical Trial at RCCA?

If you’re interested in participating in a clinical trial through RCCA, here’s how to determine if you’re a candidate.

Step 1: Ask Your RCCA Oncologist

At your next appointment with your oncologist, ask about clinical trials and whether you may be a potential candidate for any ongoing or upcoming studies. Your doctor can let you know whether there may be relevant studies for your type of cancer, its stage, and your specific health history.

Step 2: Search RCCA’s Clinical Trials Database Online

If your oncologist recommends looking further into the available clinical trials, you can explore the hundreds of clinical trials RCCA participates in via our clinical trials database. This database lets you search for trials by keyword, category, and phase. It will show you the names of the studies, the phases and statuses they’re in, and the relevant details to give you more information.

Step 3: Review Eligibility Criteria

Once you’ve found clinical trials that seem relevant, review the eligibility criteria to see whether you meet the requirements. Common inclusion criteria include:

• Cancer type
• Cancer stage
• Prior treatment history
• Eastern Cooperative Oncology Group (ECOG) performance status

There are also some common exclusion criteria, such as certain prior treatments or other medical conditions. Certain trials are based on biomarkers, so molecular testing may be needed to determine whether you have the right biomarkers for the trial.

Step 4: The Informed Consent Process

If you meet the eligibility criteria for a clinical trial, you can officially be enrolled in the trial. Before you sign an enrollment document, however, you will participate in the informed consent process. This is a mandatory process in which researchers will educate you about the study’s procedures, benefits, and risks. Even though you sign a document, you can still withdraw from a trial at any time without penalty. Before you sign, you may want to ask some specific questions, such as:

• What are the common side effects of the treatment?
• How much time do I need to commit to hospital/doctor visits during the trial?
• Can I keep seeing my regular doctor while I am participating in the trial?
• Are there any foods, drinks, or other medications I am not allowed to take during the trial?
• Will I have to pay for any tests or the study drug?

When you know exactly what to expect during the trial, you’ll have more peace of mind throughout the process.

What to Expect During a Clinical Trial at RCCA

Once you’re enrolled in a clinical trial at RCCA, you will undergo baseline tests to check your health before the treatment begins. This helps researchers determine if the treatment changes your body or health later. Once the treatment officially starts, whether it’s a new drug, surgery, or device, you can expect:

• Frequent visits to the clinic for monitoring, which may include physical exams, blood tests, and imaging scans, such as magnetic resonance imaging (MRI) or computed tomography (CT)
• Reporting of your symptoms, feelings, and side effects
• Ready access to trial nurses and other team members for help with any questions or concerns you may have
• A final check-up once the study is over to assess your health and well-being

During a clinical trial, it’s important to remember your rights as a participant. You can always withdraw from a clinical trial at any time and for any reason. This will not affect your standard of care or lead to any penalties.

Explore Community-Based Cancer Clinical Trials Near You in NJ, CT, MA, and the Washington, D.C., Area

When you’re fighting cancer, you want the best chances for a positive outcome. Participating in a cutting-edge clinical trial can give you access to innovative treatments that may improve your prognosis. At Regional Cancer Care Associates (RCCA), we provide patients in New Jersey, Connecticut, Massachusetts, and the Washington, D.C., area with clinical trial access at more than 20 community-based locations near you. To learn more about cancer clinical trials near you, explore our currently enrolling trials or request a clinical trial consultation by contacting us today.

Frequently Asked Questions About Clinical Trials

What is a cancer clinical trial?

A cancer clinical trial is a research study that is used to test new methods of cancer prevention, diagnosis, or treatment.

Are cancer clinical trials safe?

Yes, cancer clinical trials are generally safe. They follow strict safety standards and ethical guidelines to prevent any dangerous effects. However, there is still some level of risk with any research study.

Will I receive a placebo in a cancer clinical trial?

No., Placebos are used in some clinical trials evaluating therapies for other less-serious diseases, but placebo-only study arms are not used in cancer-specific trials. However, when a study is evaluating the safety and effectiveness of a combination of two or more cancer therapies, patients may be assigned to receive either the combination therapy or just one of the therapies in the combination, with a placebo added to that agent so that its impact as a solo treatment can be compared with that of the combination regimen.

Who qualifies for a cancer clinical trial?

The qualifications for cancer clinical trials vary based on the specific trial. Eligibility criteria often include the cancer type and stage, the patient’s prior treatment history, and the patient’s Eastern Cooperative Oncology Group (ECOG) performance status, which is a measure of well-being.

How do I find a cancer clinical trial near me?

To find a cancer clinical trial near you, you can ask your oncologist or do research online. At RCCA, you can use our clinical trial database to explore the trials we participate in.

What are the benefits of joining a clinical trial?

The benefits of joining a clinical trial include:

• Access to innovative therapies
• Advancing cancer research
• Getting close monitoring
• Having frequent contact with your care team
• Often, receiving the investigational treatment at no cost

Can I leave a clinical trial if I change my mind?

Yes, you can leave a clinical trial at any time if you change your mind.

How do I know if a clinical trial is right for me?

To know whether a clinical trial is right for you, you’ll need to:

• Discuss your interest with your oncologist
• Search for clinical trials that match your cancer type and stage
• Determine if you meet the eligibility criteria