A clinical trial is a research study designed to evaluate how well a promising new medical approach works in people. It includes research done to evaluate new ways to prevent, screen for, diagnose and/or treat cancer. At Roswell Park, up to 50% of our patients are eligible to enter clinical trials. Many types of treatment can be tested including:
- New ways of preventing cancer such as drugs, diet, and/or exercise
- New drugs to treat cancer
- New ways to use existing treatment such as surgery or radiation therapy
When clinical trials identify new and effective treatments, these treatments will eventually become the new standard of care that will be offered to future patients. Today's standard treatments were researched and proven by clinical trials done in the past.
Our current Clinical Trials can be accessed via our new Clinical Trials Search web interface.
What Are The Potential Risks And Benefits Of Clinical Trials?
Potential benefits include:
- Cancer care provided by top physicians in the field of cancer research.
- Access to new drugs and treatment methods before they are widely available.
- Close monitoring of your health care and any side effects.
- A more active role in your own health care.
- An opportunity to make a valuable contribution to cancer research
The potential risks include:
- New drugs and procedures may have side effects or risks unknown to the doctors.
- New drugs and procedures may be ineffective, or less effective, than current approaches.
- Even if a new approach has benefits, it may not work for you.
What Are The Phases Of A Clinical Trial?
Most clinical research involves the testing of a new drug. The study progresses in an orderly series of steps, called phases. This allows researchers to ask and answer questions in a way that gives reliable results about the treatment and protects the patients. Clinical trials are usually classified in three phases:
- Phase I trials are the first step in testing a new approach in humans. In these studies researchers evaluate how a new agent should be given (by mouth, injected into a vein, or injected into the muscle), and how often and what dose is safe. Researchers watch closely for any harmful side effects. Phase I trials usually enroll a small number of patients and take place at only a few locations. The patients are divided into small groups, called cohorts. Each cohort is treated with an increased dose of the new treatment or technique. The highest dose with an acceptable level of side effects is determined to be appropriate for further testing.
- Phase II trials study the safety and effectiveness of an agent or intervention, and evaluate how it affects the human body. Phase II studies usually focus on a particular type of cancer, and include fewer than 100 patients.
- Phase III trials compare a new agent or intervention (or new use of a standard one) with the current standard therapy (a currently accepted and widely used treatment for a certain type of cancer, based on the results of past research). Participants are selected by chance (usually the selection process is computer–driven) to be in the standard group or the new group. This method, called randomization, helps to avoid bias and ensures that human choices or other factors do not affect the study's results. In most cases, studies move into phase III testing only after they have shown promise in phases I and II. Phase III trials may include hundreds of people across the country.
What Are Some Questions People Might Ask Their Health Care Provider before Entering a Clinical Trial?
It is important to ask questions before deciding to enter a clinical trial. Here are some questions patients might want to ask their doctor or nurse:
The Study
- What is the purpose of the study?
- Why do the researchers think the approach being tested may be effective? Has it been tested before?
- Who is sponsoring the study?
- Who has reviewed and approved the study?
- What are the medical credentials and experience of the researchers and other study personnel?
- How are the study results and safety of participants being monitored?
- How long will the study last?
- How will the results be shared?
Possible Risks and Benefits
- What are the possible short–term benefits?
- What are the possible long–term benefits?
- What are the short–term risks, such as side effects?
- What are the possible long–term risks?
- What other treatment options are available?
- How do the possible risks and benefits of the trial compare with those of other options?
Participation and Care
- What kinds of treatment, medical tests, or procedures will occur during the study? How often will patients receive the treatments, tests, or procedures?
- Will treatments, tests, or procedures be painful? If so, how can the pain be controlled?
- How do the tests in the study compare with what people might receive outside the study?
- Will participants be able to take their regular medications while in the clinical trial?
- Where will the participants receive their medical care? Will they be in a hospital? If so, for how long?
- Who will be in charge of the participants' care? Will they be able to see their own doctors?
- How long will participants need to stay in the study? Will there be follow-up visits after the study?
Personal Issues
- How could being in the study affect the participants' daily lives?
- What support is available for participants and their families?
- Can potential participants talk with people already enrolled in the study?
Cost Issues
- Will participants have to pay for any treatment, tests, or other charges? If so, what will the approximate charges be?
- What is health insurance likely to cover?
- Who can help answer questions from the insurance company or health plan?
What are eligibility criteria, and why are they important?
Each study's protocol has guidelines for who can or cannot participate in the trial. These guidelines, called eligibility criteria, describe characteristics that must be shared by all participants. The criteria differ from study to study. They may include age, gender, medical history, and current health status. Eligibility criteria for treatment studies often require that patients have a particular type and stage of cancer.
Enrolling participants with similar characteristics ensures that the results will be due to what is under study and not other factors. In this way, eligibility criteria help researchers achieve accurate and meaningful results. These criteria also make certain that people who could be made worse by participating in the study are not exposed to the risk.
What is informed consent?
Informed consent is a process by which people learn the important facts about a clinical trial to help them decide whether to participate. This information includes details about what is involved, such as the purpose of the study, the tests and other procedures used in the study, and the possible risks and benefits. In addition to talking with the doctor or research nurse, people receive a written consent form explaining the study. People who agree to take part in the study are asked to sign the informed consent form. However, signing the form does not mean people must stay in the study. People can leave the study at any time—either before the study starts or at any time during the study or the follow-up period. The informed consent process continues throughout the study. If new benefits, risks, or side effects are discovered during the study, the researchers must inform the participants. They may be asked to sign new consent forms if they want to stay in the study.
This information is provided in collaboration with the National Cancer Institute.
