Frequently Asked Questions
- What are cancer clinical trials?
Cancer clinical trials are research studies or protocols that test how well detection methods and therapies work in people, with the goal to find better ways to treat and eventually prevent cancer. Through clinical trials, researchers can determine the safety and effectiveness of new treatments under the supervision of a physician and other research professionals.
Volunteers who participate in clinical trials receive new, innovative research treatments before they are widely available. Knowledge on treatments gained from clinical trials can influence cancer care and help prevent cancer or treat people with cancer in the future.
- What are the phases of clinical trials?
Therapeutic-interventional clinical trials involve a series of steps, called phases. If a new treatment is successful in one phase, it will proceed to further testing in the next phase - until the ultimate goal is achieved, FDA approval. During the early phases (Phases I and II), researchers determine the new treatment’s safety, side effects, and appropriate dose. They make sure that the treatment has notable benefit, such as slowing tumor growth. In the later phases (Phases III and IV), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments.
- Phase I Trials: Used to learn the “maximum tolerated dose” of a new treatment, this phase involves a small number of patient volunteers followed primarily for side effects and how the medication or treatment acts in the body.
- Phase II Trials: This phase involves a larger volunteer group and studies a medication’s or treatment’s dose and associated side effects, how the treatment is used in the body, and how it helps the cancer under study.
- Phase III Trials: This phase evaluates how the disease responds to this treatment, comparing the trialed medication to existing standard treatments.
- Phase IV Trials: After the drug or treatment has been marketed to the general population, this phase is used to gather information on the medication’s or treatment’s effects in various populations and any side effects associated with long-term use.
- What are the types of clinical trials?
In addition to clinical trial phases, trials are also affiliated with a research type or category. These include:
- Interventional: Participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study protocol. The participants may receive diagnostic, treatment, behavioral, or other types of interventions.
- Observational: Studies that focus on cancer patients and healthy populations and involve no prospective intervention or alteration in the status of the participants. The participants in the study may receive diagnostic, therapeutic, or other interventions, but the investigator of the observational study is not responsible for assigning specific interventions to the participants of the study.
- Ancillary or Correlative: Ancillary studies are stimulated by, but are not a required part of, a main clinical trial/study, and utilize patient or other resources of the main trial/study to generate information relevant to it. Correlative studies are laboratory-based and use specimens to assess cancer risk, clinical outcomes, response to therapies, etc.
- Basic Science (BAS): Protocol designed to examine the basic mechanisms of action (e.g., physiology, biomechanics) of an intervention.
- Diagnostic (DIA): Protocol designed to evaluate one of more interventions aimed at identifying a disease or health condition.
- Cancer Care Delivery Research (CCDR): Protocol designed to evaluate the delivery, processes, management, organization, or financing of healthcare.
- Prevention (PRE): Protocol designed to assess one or more interventions aimed at preventing the development of a specific disease or health condition.
- Screening (SCR): Protocol designed to assess or examine methods of identifying a condition (or risk factor for a condition) in people who are not yet known to have the condition (or risk factor).
- Supportive Care (SUP): Protocol designed to evaluate one or more interventions where the primary intent is to maximize comfort, minimize side effects, or mitigate against a decline in the participant’s health or function. In general, supportive care interventions are not intended to cure a disease.
- Treatment (TRE): Protocol designed to evaluate one or more interventions for treating a disease, syndrome, or condition. Note: This equates to therapeutic trials in previous versions of the guidelines.
- Other (OTH): Not in other categories
- What are the benefits of participating in a clinical trial?
The decision to participate in a clinical trial is complex. For some, a clinical trial may be the best treatment option available despite the uncertainty of the outcome. For all volunteers, participation in clinical research is crucial in influencing the direction of cancer care and improving health for today’s and future generations. Already, the health of millions has been improved because of the willingness of thousands like you to take part in clinical trials to help researchers make significant, life-saving and life-enhancing medical advances.
- What are the risks associated with clinical trials?
The ethical and legal codes that govern medical practice also apply to clinical trials, and every clinical trial in the United States must be approved and monitored by an Institutional Review Board (IRB)* to make sure the risks are as low as possible and are worth the potential benefits.
However, like in routine medical care, clinical trials are not risk-free. Clinical studies pose risks of minor, brief discomfort or other complications requiring medication attention. Weigh these risks and explore the options best for your individual needs with your physician. All known risks are fully explored with volunteers before they can consent to join a study.
*An IRB is a committee of physicians, statisticians, community advocates, and others that reviews and approves clinical research involving human subjects, making sure the trial is ethical and protects the rights of participants. IRBs may stop clinical trials when protocols aren’t followed or appear to be causing unexpected harm.
- Is there a chance I would receive a placebo?
In clinical trials, the use of placebos or “sugar pills,” which are inactive drugs with no treatment value, is rare. They are only used when it is scientifically necessary, such as an instance when a standard treatment does not exist for the condition in study, and so the new treatment in the clinical trial would be compared with a placebo. Or in cases of studying newer, targeted drugs that slow tumor growth, researchers need a control group of patients with placebos to determine whether tumor stabilization or shrinkage was caused by the treatment or reflective of the tumor’s natural behavior. More often, however, placebos are given along with a standard treatment.
Talk with your physician to understand the study you are entering and its potential impact on your course of treatment.
- How can I participate in a clinical trial?
If you are interested in participating in a cancer prevention or cancer treatment clinical trial, consult with your physician. Next, you can contact the Northwest NCI Community Oncology Research Program (NW NCORP) offices:
Northwest NCI Community Oncology Research Program
314 Martin Luther King Jr. Way, Suite 402
Tacoma, WA 98405
Phone: (253) 403-5279
Fax: (253) 403-2391
Our staff will provide information on what will occur in the clinical trial, all known side effects, and your rights as a participant. We will also assess your case and medical history, and answer any questions you might have. In working closely with you and your physician, we will determine whether you meet the eligibility criteria for the requested trial. Next, if you are still interested in participating, you will sign a patient consent form that describes in detail associated risks and potential benefits of the trial.
- What will happen during my clinical trial?
Upon your enrollment in a clinical trial, our staff will provide the treatment as directed by the National Cancer Institute (NCI), carefully monitoring your progress throughout treatment. As the study progresses, any clinical findings will be shared with you. If at any time you decide you want to withdraw from the clinical trial, you may speak with your physician and terminate your participation.