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Pancreatic cancer patients who participate in clinical research have better outcomes. Every treatment available today was approved through a clinical trial. The Pancreatic Cancer Action Network strongly recommends clinical trials at diagnosis and during every treatment decision.
The FDA Approval Process
When a drug or treatment enters the clinical trial process, it must pass through three phases of testing before becoming eligible for Food and Drug Administration (FDA) approval. Only if the treatment proves to be safe and promising at each phase, is it allowed to proceed to the next phase of testing.
Phases of Clinical Trials
The United States Food and Drug Administration (FDA) regulates all clinical trials to protect participants and the public. The FDA reviews and analyzes data from successful clinical trials to determine whether an experimental treatment should be approved for a specific disease, like pancreatic cancer.
Pancreatic cancer clinical trials may study either new experimental treatments or treatments already available for other conditions. Since all cancers are different, a drug that is approved by the FDA for the treatment of one type of cancer may not be approved to treat pancreatic cancer.
The drugs that are currently approved to treat pancreatic cancer were made available to patients after showing efficacy and safety in clinical trials.
When a drug or treatment enters the clinical trial process, it must pass through three phases of testing before becoming eligible for FDA approval. A treatment will only go to the next phase of testing if it has been shown to be safe and promising at each stage.
Phase I
Phase I clinical trials are the first step in testing a new treatment or combination of treatments. These trials often involve drugs that have not yet been given to humans but have shown promise in the laboratory. Phase I trials enroll a small group of participants, typically 20 to 40 people. The goal of these trials is to determine safety, appropriate dosage and how the treatment is processed inside the body. Participants are closely monitored for side effects and doses are adjusted as needed. Often, eligibility requirements related to previous treatments are less strict in Phase I trials, allowing patients who have already had multiple treatments to participate. Sometimes, Phase I trials can be open to people who have different kinds of tumors, like breast, lung and prostate, instead of just pancreatic cancer. These are known as solid tumor trials. People often choose to participate in Phase I trials when they are not eligible for later-phase trials and are not responding to standard treatments.
Phase II
Phase II clinical trials enroll a larger group of participants, usually 25 to 100 people. In these trials, participants generally have a specific type of disease, like pancreatic cancer. The goal of a Phase II trial is to see if the new treatment is safe and how it affects the cancer. Some Phase II trials may be randomized, which means that participants are randomly assigned (by chance) to different treatment groups.
These trials may involve randomization between standard treatments and the experimental treatment, or randomization between two experimental treatments.
Phase III
Phase III clinical trials test how the new treatment compares with the standard treatment. These trials enroll a large group of participants, typically 100 to 1,000 or more. They are designed to see if the new treatment is statistically more effective than the standard treatment in the group of people who participated in the study. Phase III trials are usually randomized. This means that people are randomly assigned (by chance) to different treatment groups. Each group receives a different treatment; some people receive the new treatment, while others receive the standard treatment.
In some Phase III trials, neither the participant nor the doctor knows to which treatment group the participant has been assigned. This is called a double-blind study, and it helps keep research studies free of bias toward the new or existing treatment. If the new treatment is found to be effective and meets safety requirements throughout all three phases, the sponsor of the trial may submit an application to the FDA asking for approval of the new treatment.
Phase IV
Phase IV trials take place after a therapy has been approved by the FDA. The treatment is observed in larger populations to determine long-term safety and cost effectiveness and to improve the management of side effects.
Information provided by the Pancreatic Cancer Action Network, Inc. (“PanCAN”) is not a substitute for medical advice, diagnosis, treatment or other health care services. PanCAN may provide information to you about physicians, products, services, clinical trials or treatments related to pancreatic cancer, but PanCAN does not recommend nor endorse any particular health care resource. In addition, please note any personal information you provide to PanCAN’s staff during telephone and/or email communications may be stored and used to help PanCAN achieve its mission of assisting patients with, and finding cures and treatments for, pancreatic cancer. Stored constituent information may be used to inform PanCAN programs and activities. Information also may be provided in aggregate or limited formats to third parties to guide future pancreatic cancer research and education efforts. PanCAN will not provide personal directly identifying information (such as your name or contact information) to such third parties without your prior written consent unless required or permitted by law to do so. For more information on how we may use your information, you can find our privacy policy on our website at https://www.pancan.org/privacy/.
