Clinical Trials FAQs

What is a cancer clinical trial?

A cancer clinical trial is a research study involving people that evaluates approaches to preventing, diagnosing, treating, or managing cancer. Treatment trials may investigate new medications, combinations of existing therapies, surgical or radiation techniques, or other interventions. Some studies focus on improving quality of life or reducing treatment-related symptoms.

Each trial follows a detailed research plan, called a protocol, that defines its purpose, participant eligibility, procedures, safety monitoring, and how results will be evaluated. An investigational treatment is still being studied and may not work as well as established treatment or may have unexpected side effects.

Why are clinical trials important?

Clinical trials help researchers determine whether new approaches are safe and effective and how they compare with existing standards of care. Many treatments used in cancer care today were evaluated through clinical research before becoming widely available. Trials may also help physicians understand which patients are most likely to benefit from particular treatments and how to manage side effects.

Research participation contributes to medical knowledge that may improve care for future patients. However, participation does not guarantee that an individual patient will benefit from the treatment being studied.

What are the different phases of clinical trials?

Clinical trials evaluating new drugs are commonly organized into phases, although not every study follows the same sequence or design.

• Phase I: Evaluates safety, dosage, side effects, and how an investigational treatment behaves in the body.
• Phase II: Further evaluates safety and looks for evidence that a treatment may be effective for a particular cancer or group of patients.
• Phase III: Often compares an investigational treatment with an existing standard of care in larger groups of participants.
• Phase IV: Studies a treatment after regulatory approval to gather additional information about safety, effectiveness, or long-term use.

Some studies combine phases, such as Phase I/II or Phase II/III, while other types of clinical research use different designs. A study’s phase is only one factor to consider when evaluating whether participation is appropriate.

Does participating in a clinical trial mean I will receive an experimental treatment instead of standard care?

Not necessarily. Some clinical trials compare an investigational treatment with an established therapy, while others add a new treatment to standard care. Certain studies evaluate treatment strategies, supportive care, imaging, or other approaches that may not involve an experimental medication.

Before participating, the research team will explain the treatments or procedures involved, whether there are different study groups, and what alternatives are available outside the trial.

Will I receive a placebo instead of cancer treatment?

Placebos are uncommon in cancer treatment trials when an effective standard treatment is available. More commonly, researchers compare a new treatment with established care, or compare standard treatment plus an investigational therapy with standard treatment plus a placebo.

If a study involves a placebo, the research team must explain its use during the informed consent process. Participants should understand which treatments they may receive, how study groups are assigned, and whether the use of a placebo could affect their care.

Who can participate in a cancer clinical trial?

Each clinical trial has specific eligibility requirements intended to identify appropriate participants and protect their safety. These may include cancer type and stage, previous treatments, age, medical history, organ function, general health, and particular tumor biomarkers or genetic changes.

Some studies are intended for patients who have not yet received treatment, while others investigate options for cancer that has returned or progressed after earlier therapies. Eligibility is determined through review of the study protocol and a patient’s medical information, sometimes followed by additional screening tests.

Should I consider a clinical trial before starting cancer treatment?

Clinical trials are not limited to patients who have exhausted standard treatment options. Depending on the diagnosis and available studies, a trial may be considered at the beginning of treatment, after surgery, during ongoing treatment, or when cancer returns or progresses.

Asking about clinical trials early can be helpful because previous treatments and the timing of therapy sometimes affect eligibility. Your oncologist can discuss whether an available study is appropriate alongside established treatment options.

What happens during the screening and informed consent process?

The research team first reviews information about your diagnosis, treatment history, and health to determine whether a study may be suitable. Screening may involve medical records, blood tests, imaging, physical examinations, or other assessments required by the study protocol.

Before any study-specific procedures requiring consent, the team will explain the trial’s purpose, potential benefits and risks, treatment schedule, alternatives, costs, privacy protections, and participant responsibilities. This process is called informed consent. You will have an opportunity to ask questions and decide whether to participate.

Signing a consent form does not mean giving up your rights, and agreeing to screening does not guarantee enrollment in the study.

What are the potential benefits and risks of participating?

Potential benefits may include access to an investigational approach that is not otherwise available and the opportunity to contribute to cancer research. Some studies involve additional monitoring or assessments related to the research.

Risks may include unexpected side effects, treatment-related complications, additional appointments or testing, and the possibility that the investigational approach will not work or may be less effective than established care. The balance of potential benefits and risks varies by study and individual medical circumstances.

Your care team and the research investigators can help you compare the study with other appropriate treatment options before making a decision.

How are patients assigned to different treatment groups?

Some clinical trials use randomization, a process that assigns participants to different study groups by chance. Randomization helps researchers make fair comparisons between treatments and reduce bias in the results. Depending on the trial, participants may receive an investigational treatment, an established therapy, or different combinations of treatment.

In a randomized trial, neither the patient nor the treating physician chooses the assigned group. The study team will explain the assignment process, the treatments involved, and whether participants and researchers will know which treatment is being received.

Will my insurance cover the costs of a clinical trial?

Clinical trial expenses generally fall into two categories: routine patient care costs and research-related costs. Routine care may include medical visits, tests, or treatments that would ordinarily be part of your cancer care. Research-related costs may include investigational medications or procedures performed specifically for the study.

Insurance coverage, study sponsor responsibilities, and possible out-of-pocket expenses vary. Certain health plans are required to cover qualifying routine patient care costs in approved clinical trials, but coverage rules and individual circumstances differ.

Before enrolling, ask the research team which expenses are covered by the study, what may be billed to insurance, and whether you could be responsible for additional costs.

Will I be compensated for participating?

Some studies offer reimbursement for transportation, parking, lodging, or other approved expenses. Certain trials may provide compensation for time or participation, while others do not. Financial arrangements depend on the study protocol and sponsor.

Any available compensation or reimbursement should be explained before enrollment. Patients should not assume that participation, travel, or other expenses will automatically be covered.

What should I expect during the study?

Participation may include scheduled appointments, laboratory testing, imaging, treatment visits, symptom assessments, and follow-up evaluations. Some studies involve more frequent monitoring than standard treatment, while others follow a similar schedule. The number of visits and time commitment depend on the trial.

Members of the research team will explain the schedule, how side effects are monitored, whom to contact with concerns, and what information you should report during participation. You should also ask how the research team will communicate with your regular oncology providers.

How long does a clinical trial last?

The length of participation varies considerably. Some studies involve treatment or observation for several weeks, while others continue for months or years. A study may include an initial screening period, active treatment, and follow-up appointments after treatment ends.

The research team can explain the anticipated duration of participation, the frequency of visits, and whether long-term follow-up will be requested.

Can I leave a clinical trial after enrolling?

Yes. Participation in a clinical trial is voluntary, and you may withdraw your consent at any time. Choosing not to participate or deciding to leave a study does not remove your right to appropriate medical care.

If you decide to withdraw, inform the research team so they can discuss safe treatment transitions, follow-up care, and any recommended final assessments. You may also be asked whether you are willing to allow continued collection of certain follow-up information, but that decision should be explained to you.

What happens when the clinical trial ends?

When your participation ends, the research team and your treating physicians can discuss appropriate next steps. Depending on the study, these may include returning to standard treatment, beginning another therapy, continuing follow-up care, or considering a different clinical trial.

Access to an investigational treatment after a study ends is not always available and depends on the protocol, sponsor, regulatory requirements, and individual circumstances. Ask about these arrangements before enrollment, especially if the investigational treatment appears to be helping.

What if there is no clinical trial available for my cancer?

Not every patient will qualify for a currently available study. Eligibility criteria, enrollment status, and the types of cancer being investigated change as trials open, close, or complete enrollment.

If a suitable study is not available at Saint John’s Cancer Institute, ask your oncologist or the clinical research team about other treatment options and whether additional studies at other institutions may be appropriate. You may also review updated trial listings periodically. Contact the research team to learn whether there is a process for future inquiries or trial matching.