What are clinical trials?
Clinical trials are research studies that investigate new treatments or new combinations of treatments. Pancreatic cancer clinical trials are necessary to determine whether new therapies developed in the laboratory are beneficial to people living with pancreatic cancer. The United States Food and Drug Administration (FDA) reviews and analyzes data from successful clinical trials to determine whether a new treatment should be approved for a specific disease, such as pancreatic cancer.
Why are clinical trials important?
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.
In the fight against pancreatic cancer, clinical trials canprovide the best treatment options, and they give patients early access to cutting-edge therapies that lead to progress in research, improved treatment options and better outcomes for more patients.
What are the benefits and risks of participating in a clinical trial?
- Possibility that the drugs or treatment program used in the trial will be better than currently approved treatment options.
- Care is provided by top doctors and nurses at leading healthcare facilities.
- Access to new treatments or treatment strategies that may not otherwise be available.
- Closer monitoring of the patient.
- Helping to advance treatment of the disease.
- Possibility of unexpected or unpleasant side effects.
- Chance that the new drug or treatment may be ineffective or less effective than current options for pancreatic cancer.
- May require greater time commitment due to extra clinic visits for treatments or monitoring.
- Additional costs may be involved (i.e., housing and transportation, insurance payment for treatment outside covered network).
What is Patient Services?
Patient Services is the first place to call after a diagnosis of pancreatic cancer or at any point in your journey. A highly trained and compassionate Patient Services Case Manager can help you access personalized services — free of charge.
No organization supports pancreatic cancer patients like we do. Through our Patient Services, we provide more resources and speak with more patients and caregivers than any other pancreatic cancer organization in the world.
How does a new treatment get FDA approval?
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 will it proceed to the next phase of clinical trial testing.
Phase I
This is the first step in testing a new treatment in humans after the new treatment has already shown some promise in the laboratory. A small group of participants (20 to 40 people) are tested with the new treatment 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.
Phase I trials may be open to participants with any type of solid tumor (such as breast, lung and prostate tumors) and not only to those with pancreatic tumors. Patients often choose to participate in Phase I trials when they are not eligible for Phase II or Phase III trials.
Phase II
After completion of the Phase I trial, the treatment is tested in a Phase II trial, which involves a larger group of participants (25 to 100 people). In these studies, participants have a specific type of disease, such as pancreatic cancer. The goal of a Phase II trial is to begin to study the treatment's effect on the disease.
Phase III
After completion of the Phase II trial, the new treatment is tested in a Phase III trial, which may involve 100 to 1,000 or more people. The goal of a Phase III trial is to compare the new treatment with the currently approved standard treatment. To do this, patients are randomized (assigned by chance) to different treatment groups — the new treatment group or the standard treatment group. To prevent bias, neither the doctor nor the participant chooses the treatment group. If a Phase III trial shows that the new treatment is safe and more effective than current standard treatments, an application for FDA approval may be submitted.
When should I consider participating in a clinical trial?
The Pancreatic Cancer Action Network strongly recommends clinical trials at diagnosis and during every treatment decision.
Who can participate in a clinical trial?
Each clinical trial enrollment guidelines that must be met by each patient in order to participate. Participants must meet a list of standard requirements, such as:
- Stage and type of cancer
- Prior treatments received
- Medical History
All phases of clinical trials usually require patients to have good physical function (also called performance status, the ability to do basic tasks like eating, bathing, and moving around) and healthy major organ (liver, kidney, heart) function.
Can a participant leave a clinical trial after it has begun?
Yes. Clinical trial participants have the right to stop participating in the trial at any time.
Will a participant ever receive a placebo (“sugar-pill”) instead of treatment in a clinical trial?
A placebo, sometimes known as a “sugar pill,” does not contain active medication. In cancer treatment clincial trials, placebos are never used in the place of actual treatment. All trial participants will receive either the experimental treatment or a current approved standard of care. In some clinical trials, a placebo may be added to the standard treatment for comparison reasons.
Should a patient be concerned about the side effects of an experimental drug?
Before a patient begins a clinical trial, the study doctor or nurse will fully explain the anticipated side effects that patients may experience due to the experimental drug. It is important to remember that all cancer treatments, including the standard treatment, may cause side effects. Side effects can range from mild to severe, but can often be managed successfully with the help of the healthcare team.
How do I find a pancreatic cancer clinical trial?
We maintain the most comprehensive and up-to-date database of pancreatic cancer clinical trials available in the United States. There are two ways you can access this free information:
1. Our Patient Services Case Managers can run a personalized clinical trials search for you. They will base the search on information you provide, like how far you are willing to travel, diagnosis information and treatment history, to match your specific needs.
2. You can start your own search using our Clinical Trial Finder. This easy-to-use online tool allows you to enter information about how far you are willing to travel, diagnosis information and treatment history to see a list of clinical trials that match what you need. You can select the trials of interest to you and download them or email them.
Once you receive your personalized trial information, our Patient Services Case Managers are available to walk through the information with you, providing in-depth details and answering any questions you may have. Then, discuss search results with your healthcare team to determine if a clinical trial is the right option for you. Case Managers are available Monday – Friday, 7 a.m. – 5 p.m. PT. Contact a Case Manager.
To learn more about the clinical trials process, you can access our free booklet, Clinical Trials: Understanding How Pancreatic Cancer Clinical Trials Work.
How do I know which clinical trial is best for me?
You should discuss enrollment in a clinical trial with your healthcare team to determine if it is the right choice for you.
To help patients and their doctors determine if a clinical trial is the right choice, our Know Your Tumor® personalized medicine service provides eligible pancreatic cancer patients and their oncologists with information about the biology of their tumor. Through Know Your Tumor, you and your healthcare team have access to information about treatments – including available clinical trials – that are personalized to you. Our Patient Services Case Managers are available to provide additional information and enroll you in the service.
Case Managers are available Monday – Friday, 7 a.m. – 5 p.m. Pacific Time.
What questions should I ask when thinking about participating in a clinical trial?
Questions to ask when thinking about participating in a clinical trial:
- Are there pancreatic cancer specific clinical trials available at this hospital/institution?
- How can I find out more about these clinical trials?
- Do you know of any other trials that are available to me at other locations?
Contact a Patient Services Case Manager to discuss other questions, including:
- Questions to ask about the trial
- Questions to ask about risk and benefits
- Questions to ask about medical care
- Questions to ask yourself about personal issues and cost issues
You can request our free patient education packet, which includes our booklet, Clinical Trials: Understanding How Pancreatic Cancer Clinical Trials Work. This booklet provides lists of questions to consider when thinking about enrolling in a clinical trial.
Where are clinical trials located?
Clinical trials are conducted by doctors and institutions (hospitals, academic medical centers, cancer centers, community hospitals) throughout the country. Depending on the trial, it may take place in one, two or several different cities. Patient Services Case Managers can help each patient locate the nearest suitable trial location.
Case Managers are available Monday – Friday, 7 a.m. – 5 p.m. Pacific Time.
What rights and protections do participants have in a clinical trial?
The most important goal of researchers is to protect the well-being of clinical trial participants. There are several steps that researchers must follow to ensure the safety of participants. One of these is informed consent — a process required by the FDA that makes sure patients are given complete information about the clinical trial. Each participant must read and sign an informed consent form before any treatment or testing related to a clinical trial can begin.
Who pays for a clinical trial?
It depends on the type of clinical trial. Usually, there are two types of financial costs participants may encounter during a clinical trial – research costs and routine medical costs.
Research costs include any treatment, test or procedure specifically done for the trial. In most cases, these are covered by the clinical trial sponsor.
Routine medical care costs include any treatment, test or procedure that a patient would receive even if they were not inin a trial. Most states require health insurance plans to cover the routine care costs of a clinical trial.
Additionally, each research institution or hospital has an independent committee, called an Institutional Review Board (IRB), that reviews and monitors clinical trials.