Clinical Trials Frequently Asked Questions

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Clinical trials are research studies that investigate new treatments, new combinations of treatments and new methods of diagnosis as well as surveillance, prevention, and supportive care. Clinical trials play an important role for all individuals living with pancreatic cancer, throughout their entire journey. Clinical trials help advance progress in treatment options, surveillance, diagnostics, maintenance, early detection and prevention. 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.

Clinical trials are the only way for researchers to make progress and develop new treatment options for pancreatic cancer. For any pancreatic cancer therapy to be approved, it must pass through the clinical trial process to ensure that it is safe and effective for patients with pancreatic cancer. Clinical trials allow researchers to determine whether a new and potentially better treatment is safe and beneficial for all patients. They also provide patients the opportunity to receive a promising new drug or treatment.

When should I consider participating in a clinical trial?

PanCAN strongly recommends clinical trials at diagnosis and during every treatment decision. Pancreatic cancer patients who participate in clinical trials have better outcomes. Since people with pancreatic cancer may have fewer treatment options compared to other diseases, clinical trials are the best way to have access to therapies that are new and possibly better than the standard of care.

Only through clinical trials will researchers develop new and more effective treatment options for individuals diagnosed with pancreatic cancer. Since participating in a clinical trial is an important and personal decision, patients and their caregivers should work with their healthcare team to determine whether participating in a clinical trial is appropriate.

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.

Potential Risks

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 cost may be involved (i.e., housing and transportation, insurance payment for treatment outside covered network).

Side effects are unwanted effects that result from taking a drug. It is important to remember that all cancer treatments, including the standard treatment, may cause side effects. The degree to which someone experiences side effects can range from mild to severe. It is very important to discuss any and all side effects with the doctor. In many cases, doctors can provide supportive care to manage any unpleasant effects of the treatment. The doctor can prescribe medications to help control side effects or lower the dose of the treatment drug.

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. PanCAN Patient Services Case Managers can help each patient locate the nearest suitable trial location.

PanCAN Patient Services maintains the most comprehensive and up-to-date database of IRB-approved pancreatic cancer clinical trials taking place throughout the United States. PanCAN has dedicated staff members who ensure that the information provided to patients is as accurate as possible. Information about these clinical trials is available to the public free-of-charge in two ways:

Contact PanCAN Patient Services for personalized clinical trials searches based on a patient’s specific diagnosis, including type and stage of pancreatic cancer, treatment history and geographical location.
Use our Clinical Trial Finder. Through this tool, visitors can complete a series of questions about the patient’s diagnosis to find available clinical trials for which the patient may qualify and to request more details about the trials they are interested in. Patient Services will send additional information about the requested trials for which the patient may qualify.

For more information on what to do after receiving a list of clinical trials, contact PanCAN Patient Services and request the Clinical Trials Next Steps fact sheet.

Other Options

The U.S. National Institutes of Health (NIH) provides information about clinical trials at clinicaltrials.gov. Clinical trial listings are provided for all health conditions, not just cancer.

The National Cancer Institute (NCI), a division of the NIH, provides information specifically on cancer clinical trials by calling 1-800-4-CANCER or online at cancer.gov/clinicaltrials.

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® precision 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 PanCAN 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. Contact a Case Manager.

To participate in a clinical trial, people must meet the clinical trial’s enrollment guidelines or standard requirements. For cancer clinical trials, the standard requirements usually include:

Type and stage of cancer
Past treatments received
Age
Medical History
Current medical condition

Usually, all phases of clinical trials require an adequate level of physical functioning (known as performance status) and good major organ (liver, kidney, heart, etc.) function. In addition, some trials require that participants be off treatment for a specified length of time before participating in the trial. Other trials, like post-surgery trials, may require participants to enroll in the trial within a certain amount of time after surgery. For example, people who enroll in the trial may have to start the treatment being studied within two to three months after surgery. This is known as a washout period.

It’s important to have a conversation with your healthcare team when considering clinical trials.

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?

Questions to ask about the trial:

What is the purpose of the trial?
What are the eligibility criteria?
What phase is the trial?
Why do researchers believe the new treatment being studied may be effective?
Has this treatment been studied before? What were the results of previous trials?
Who is sponsoring the trial? Who has reviewed and approved it?
How are the trial results and the participants’ safety checked?
How long will the trial last?
What will I have to do if I participate?
How many study arms does the trial have? What treatment does each arm receive?
Will I know if I am taking the experimental treatment?

Questions to ask about possible risks and benefits:

What are the expected short-term and long-term benefits of this treatment?
What are the short-term and long-term risks, such as side effects?
How can I best control side effects while I am participating in the trial?
How do the benefits and risks of the trial compare with benefits and risks of other treatment options?

Questions to ask about medical care:

What kinds of therapies, tests or procedures will I receive during the clinical trial?
Will I be able to take my regular medications?
Who will be in charge of my care? Will I be able to see my own doctor?
Where will my treatment take place? Will I have to be in the hospital? If so, how often and for how long?
How often will I need to come to the clinic for treatments or tests?
How will I know if the treatment is working?
How does the care compare with what I would receive outside the trial?
Is there any pain or other side effect associated with the therapies, tests or procedures? If so, how severe, and how long will the pain or side effects last?
How often and for how long will I receive the treatment?
How long will I need to remain in the trial?
Will there be follow-up after the trial? For how long and what will it consist of?
Will I be expected to fill out any questionnaires (such as quality of life surveys)? If so, how much time will these questionnaires take and how often will I complete them?

Personal issues

How will the trial affect my daily life?
What treatment plan will I choose if I do not join a clinical trial?
Is the time required to participate in a clinical trial reasonable for me and my family?
What support services are available to me and to my family?

Cost issues

Will I have to pay for any part of the trial, such as tests or medication? If so, what will the cost be?
What is my health insurance likely to cover or not cover?
Who can answer questions from my insurance company or managed health care plan?
Will my travel costs be covered?

In cancer treatment clinical trials, placebos (“sugar pills” or inactive medication) are never used in place of the best-known standard treatment.

In some randomized clinical trials, a placebo may be added to the standard treatment for comparison reasons. This design is mostly used when researchers are trying to determine if adding a new medicine to an existing treatment is more effective. In these cases, participants are divided into two groups - the control group and the experimental group. The control group would receive the standard treatment plus a placebo and the experimental group would receive the standard treatment plus the experimental drug.

For example, in a Phase III trial, the control group might receive Gemzar® (gemcitabine) plus a placebo while the experimental group would receive gemcitabine plus an experimental drug. While participants won’t usually know which group they are assigned to, before enrolling they are told whether there is a possibility of getting a placebo in addition to the standard active treatment so they can make an informed decision regarding participation.

No matter what, people enrolled in cancer treatment clinical trials will receive treatment and never just a sugar pill.

One of the most important goals of researchers is protecting the well-being of clinical trial participants. There are several steps that researchers must follow to ensure the safety of participants. Clinical trial participants have the right to stop participating in a trial at any time.

Informed Consent

Part of the clinical trial protocol is a process required by the FDA called informed consent. Informed consent ensures that people are given complete information about a clinical trial prior to their participation. To join any clinical trial, each participant must read and sign an informed consent form before any treatment or testing related to the clinical trial starts. This ensures that every participant understands their role and rights in the trial.

Though the FDA requires this form to be written in lay-level language, it can be difficult to understand, so it is important that the patient and their family members read it carefully to make sure the patient understands their rights before enrolling in a trial. The patient has the right to ask questions about any aspect of the clinical trial if he/she does not understand the information being presented.

Institutional Review Board (IRB)

An Institutional Review Board (IRB) is an independent committee made up of scientists, doctors, advocates and community members. The committee meets to review and monitor a hospital or research institution’s clinical trials. These committees ensure that trial participants are exposed to the minimum possible risks and that the risks associated with the trial are reasonable in relation to the expected benefits. Any institution that conducts clinical trials is required to have the trials reviewed and approved by its IRB before participants can enroll. Always ask if the trial you are interested in is IRB-approved. The informed consent should have a date stamp on it that indicates the date of IRB approval and/or the date that this approval ends.

Data Safety Monitoring Board (DSMB)

A Data Safety Monitoring Board (DSMB) is commonly used to further ensure the safety of participants. The DSMB is an impartial group that monitors the progress of clinical trials. They ensure participant safety by checking for health-related problems called adverse events and by analyzing the safety and effectiveness of the experimental treatment before the trial is completed. If participants experience unexpected or severe side effects or if evidence shows that the risks to participants outweigh the benefits, the DSMB may stop the trial.

In other cases, a trial might be stopped because trial data reveals significant benefit for patients. In cases where trials are stopped due to positive results, participants will continue to receive the treatment until they no longer have benefit even after the trial is stopped. In these cases, the treatment that showed benefit may also be made widely available to all appropriate participants through a larger trial, or the trial data will be given to the FDA for drug approval. The DSMB may be involved in all phases of trials.

There are two types of financial costs that participants may encounter when taking part in a clinical trial: research costs and routine medical care costs.

Research costs

Anything specifically performed for the purpose of the trial, including the treatment or procedure being studied and required tests. In most cases, these costs are covered by the clinical trial sponsor. Trials may be funded or sponsored through public institutions, like the National Cancer Institute, or privately through pharmaceutical companies, foundations, or academic medical centers.

Routine medical care costs

Depending on the state, person and health plan, these are services and procedures that participants would usually receive whether or not they participate in a trial. Costs may include diagnostic procedures, office visits, hospital stays and standard treatments.
The Affordable Care Act (ACA) requires all self-funded and fully insured health plans to provide coverage for routine medical costs for approved clinical trial participants. The requirement does not apply to grandfathered plans that were in place when the ACA was signed into law.
Financial costs should be discussed with the clinical trial coordinator and the patient’s insurance company before enrolling in a clinical trial. PanCAN Patient Services has listings of financial, insurance and transportation resources which may help offset additional costs.

Have More Questions?

Contact PanCAN Patient Services for more information about clinical trials or to search for options right for you.

877-272-6226

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