Phases of trials
Research studies to develop new treatments or drugs are carried out over time. There are a series of three steps to these types of studies. These are called phases. The study that you join could be a phase 1, phase 2, or phase 3 study.
Different phases have different goals and use different numbers of people. Ask your doctor or the research team about the phase of a study.
Phase 1 research studies
Phase 1 studies are the first studies done with people after a treatment or drug proves safe in animals.
Phase 1 studies:
- Are small. Usually only 15 to 30 people take part.
- Are done early in the development of a new treatment or drug.
Phase 1 studies help doctors learn:
- A safe dose for a new drug.
- The best way to give the new drug, such as pill, liquid, or shot.
- If the new drug has bad side-effects.
Phase 2 research studies
Phase 2 studies come after phase 1 studies are completed.
Phase 2 studies:
- Are still fairly small.
- Usually involve about 100 patients or less across the country.
Phase 2 studies help doctors learn:
- What effect the new drug or treatment has on a particular disease.
- How much of the new drug is needed.
- If the new drug or treatment has any bad side-effects.
Phase 3 research studies
Phase 3 studies are done after Phase 1 and Phase 2 studies. Phase 3 studies are based on the results of these earlier studies.
Phase 3 studies:
- May be large. They may involve patients across the country from different cancer treatment centers.
- Are done to compare the standard treatment or drug with the new treatment or drug.
Phase 3 studies help doctors learn:
- If a new drug or treatment works better than the standard treatment.
- Whether certain groups of patients do better with the standard treatment or the new treatment or drug.
Timeline of Treatment in Clinical Studies
People are diagnosed with cancer every day. Diagnosis is just the beginning. Be sure to know the type of cancer you have and your stage of diagnosis.
There may be a range of treatment options available, including traditional chemotherapy and radiation, holistic medicine, and state-of-the-art treatments being tested with clinical trials.
Use this resource to approach your doctor about the possibility of a clinical trial.
Whatever treatment, you choose, it’s important to have the support of family and friends. If you choose a clinical trial, make sure your friends and loved ones understand what it means to participate in this type of study. You can refer them to this website to better understand clinical trials so they can better support your decision.
There may be specific guidelines to follow during treatment. Each clinical trial is different. Make sure you understand all of the information about the study so you know what to expect.
No treatment can guarantee specific results. Regardless of which type of treatment you choose, follow your medical team’s instructions carefully to get the best results.
Things to consider
After reading about the pros & cons, you may want to talk about clinical studies with your doctor. You can use this discussion guide to help you talk with your doctor.
- Clinical trials offer high-quality care. If you are in a randomized study (a study where people are assigned to a group by chance) and do not receive the new treatment being tested, you will receive the best-known standard treatment. Everything we know indicates that both approaches should be the most effective treatments available.
- Access to promising drugs, medical devices, or treatment approaches before the general public
- If a new treatment is proven to work and you are taking it, you may be among the first to benefit.
- Free or subsidized health care for the duration of the trial
- Expert medical care at a leading health care facility
- Close monitoring of your health care and side effects
- The chance to help others and improve treatment for your type of cancer.
- There is no way for doctors, scientists, or patients to know for sure whether the current treatment or the new treatment is more effective. The goal of the study is to discover the best treatment.
- New treatments may have side effects that doctors do not expect or that are worse than those of standard treatment.
- Even if a new treatment has benefits, it might not work for you. This is also true for standard treatments.
- Health insurance and managed care providers do not always cover all patient care costs in a study. What they cover varies by plan and by study. To find out in advance what costs are likely to be paid in your case, check with your insurance company and the billing staff at your hospital or doctor’s office.
- May not have all the time you need to answer your questions in one visit.
- Use language or talk about medical procedures you don’t understand.
- Don’t have all the answers you need.
If you don’t get all the answers right away, ask your doctor if you can take more time to make a decision about your treatment. You and your doctor can work together to find answers before you make a choice about joining a research study. No matter what your doctor recommends, the choice to join or not to join a study is yours.
- Will I have to pay for any of the treatments or tests?
- What costs will my health insurance cover?
- Who can help answer any questions from my health insurance company or health plan?
- Will there be extra travel or childcare costs while I’m in the study?
- Who is paying for the study?
- How could the trial affect my daily life?
- How often will I have to come to the hospital or clinic?
- Will I have to travel long distances to take part? Is there somewhere close to home where I could receive this treatment?
- What are my other treatment choices, including standard treatments?
- How does the treatment I would receive in this trial compare with the other treatment choices?
- How could being in this study affect my daily life? Are these issues different from what I would experience if I chose the standard treatment?
- Can I talk to other people in the study?
- Will I have to travel out of the city or state?
- Will I have to stay in the hospital for my treatment? How long?