How does a new treatment get FDA approval?

Clinical trials are a necessary step in the development of new cancer treatments. When a drug or treatment enters the clinical trial process, it must pass through three phases of testing before becoming eligible for FDA approval. Only if the treatment shows promise and continues to be safe at each phase does it proceed to the next phase of clinical trial testing.

Phases of Clinical Trials
The first step in testing a new treatment or combination of treatments in humans is done during a Phase I trial. At this point, the experimental treatment has already shown some promise in the laboratory. A potential advantage of Phase I trials is that they usually have less strict eligibility requirements regarding prior treatment than Phase II or Phase III trials, allowing patients who’ve already had several treatment regimens to participate.

After a new treatment has proven to be safe in a Phase I trial, it proceeds to a Phase II trial. The goal of a Phase II trial is to begin to study the treatment’s effect against pancreatic cancer. At this point, the maximum tolerated dose has already been determined, so participants will receive the highest safe dose of the new treatment. After completion of a Phase II trial, a new treatment must go through a Phase III trial in order to obtain FDA approval.

The goal of a Phase III study is to test how the new treatment compares with the currently approved standard of care treatment. If a Phase III trial shows that the new treatment is safe and more effective than current treatments, an application for FDA approval may be submitted. Some of the benefits of participating in a Phase III trial include:

  • Patients have the opportunity to receive treatment that may be more effective than the standard of care years before the new treatment is available to other patients.
  • Phase III trials are large, multi-center trials; therefore, patients may not need to travel long distances to participate in these trials. In many cases, patients are able to find a location close to their home.
  • Treatments that have reached Phase III testing have already shown to be safe (in Phase I trials) and promising (in Phase II trials). Additionally, by participating in a Phase III trial, patients are helping to advance research towards finding more effective treatments for pancreatic cancer.

The Pancreatic Cancer Action Network’s Patient and Liaison Services (PALS) program maintains a comprehensive database containing up-to-date information about all pancreatic cancer clinical trials taking place in the United States. We offer personalized clinical trial searches so that patients can find trials for which they may be eligible.

Let us help you find a clinical trial that may be right for you!

       

The Pancreatic Cancer Action Network recommends that all patients consider clinical trials when exploring treatment options.

Clinical trials overview
Learn about pancreatic cancer clinical trials
What rights and protections do participants have in a clinical trial?
Common concerns about clinical trials
Benefits and considerations

 

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 that any personal information you provide to PanCAN’s associates 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 treatment 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.