Clinical trials are research studies in which patients help doctors find ways to improve health and cancer care. The goal of a clinical trial is to answer scientific questions that can lead to finding better ways to prevent, diagnose, or treat cancer.
What are the different types of clinical trials?
- Treatment trials test new treatments (like a new cancer drug, new approaches to surgery or radiation therapy, new combinations of treatments, or new methods such as gene therapy).
- Prevention trials test new approaches, such as medicines, vitamins, minerals, or other supplements that doctors believe may lower the risk of a certain type of cancer. These trials look for the best way to prevent cancer in people who have never had cancer or to prevent cancer from coming back or a new cancer occurring in people who have already had cancer.
- Screening trials test the best way to find cancer, especially in its early stages.
- Quality of Life trials (also called Supportive Care trials) explore ways to improve comfort and quality of life for cancer patients.
What are the phases of clinical trials?
Most clinical research that involves the testing of a new drug progresses in an orderly series of steps, called phases. This allows researchers to ask and answer questions in a way that results in reliable information about the drug and protects the patients. Most clinical trials are classified into one of three phases:
- Phase I trials: These first studies in people evaluate how a new drug should be given (by mouth, injected into the blood, or injected into the muscle), how often, and what dose is safe. A phase I trial usually enrolls only a small number of patients, sometimes as few as a dozen.
- Phase II trials: A phase II trial continues to test the safety of the drug, and begins to evaluate how well the new drug works. Phase II studies usually focus on a particular type of cancer.
- Phase III trials: These studies test a new drug, a new combination of drugs, or a new surgical procedure in comparison to the current standard. A participant will usually be assigned to the standard group or the new group at random (called randomization). Phase III trials often enroll large numbers of people and may be conducted at many doctors' offices, clinics, and cancer centers nationwide.
In addition, after a treatment has been approved and is being marketed, the drug's maker may study it further in a phase IV trial. The purpose of phase IV trials is to evaluate the side effects, risks, and benefits of a drug over a longer period of time and in a larger number of people than in phase III clinical trials. Thousands of people are involved in a phase IV trial.
What are the benefits to patients?
The National Cancer Institute lists the following benefits for participating in a clinical trial.
- Treatment studies offer sophisticated, up-to-date, cancer care. Patients who do not receive the new treatment receive up-to-date standard care.
- If a new treatment or prevention approach is successful, study participants receiving that approach are the first to benefit.
- Many people take part in a study to help others who also have cancer, and they feel good about making this contribution.
- Exploring all the treatment and prevention options may help a person feel more in control and more a part of vitally important decisions affecting his or her life.
- Taking part in a study does not end a continuing relationship with the participant’s primary care physician.
Resources for information on clinical trials:
Patients should consult their doctors about finding a clinical trial that is best for them. Other sources include the following:
National Cancer Institute at www.cancer.gov/clinicaltrials/search or call the Clinical Trials Referral Office at 1-888-624-1937 from 9:00 am – 5:00 pm Monday-Friday.
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Medical Center at www.hopkinskimmelcancercenter.org/index.cfm/cID/37
American Cancer Society at www.cancer.org or call 1-800-303-5691
Georgetown University Hospital/Lombardi Comprehensive Cancer Center at http://lombardi.georgetown.edu/clinicalprotocols for information about clinical trials at hospitals throughout the MedStar Health network: Lombardi/Georgetown University Hospital, Franklin Square Hospital Center (Baltimore, MD), Harbor Hospital (Baltimore MD), Union Memorial Hospital (Baltimore, MD), and Washington Hospital Center (Washington, DC).
Source: National Cancer Institute