Finding a Clinical Trial

Because of the nature of pancreatic cancer, the best treatment currently available—known as standard of care—is always part of a clinical trial. So, if you are participating in a clinical trial and do not receive the study medication, you will be given the standard of care treatment. Placebos—harmless medications of no therapeutic value—are rarely used in pancreatic cancer clinical trials; when they are included, they are given along with standard treatment.

All clinical trials have a set of rules about who can or cannot participate. This is called “eligibility.” Your eligibility may be based on your age, gender, overall health, type and stage of disease, whether you have had other treatment for pancreatic cancer and what kind of treatment, and other conditions. There are certain conditions that allow you to be considered for participation, called “inclusion criteria,” and others that will mean you cannot participate, called “exclusion criteria.”

Ultimately, you won’t know if you qualify until you apply. Your condition will be assessed by the researchers, who will then decide if you fit the profile for their trial. Keep in mind that if you don’t qualify for one trial, you may qualify for another, so don’t give up if you don’t get accepted by the first trial you apply for.

If you qualify for a clinical trial, you can ask any questions of the trial team at any time. You will want to know some details about the study:

• Its purpose
• Why researchers think the new treatment may be a better option
• How participants’ safety will be monitored
• Who monitors the results
• The length of the study
• Who is funding the study
• Who is in charge of the study
• How the study was developed and approved
• Whether you will hear the results of the study

It will also be important to know what is expected of you as a participant:

• The kinds of therapies, procedures, and/or tests you will be doing
• Possible side effects—pain, discomfort, nausea, and other side effects typically associated with cancer treatments
• The need for more or different tests than those involved in standard treatment
• The effect on your regular medications
• The effect on your daily life
• Whether you will have extra expenses related to the trial
• If you travel for the trial, is there help with organizing transportation and where to stay
• Where you will have your medical care
• When you need medical care, will you see your regular doctor or one from the study
• Can you talk to other people in the study
• Can you stop at any time
• What happens when the trial ends

Participating in a clinical trial has its risks, since you are trying a treatment that has not been fully tested. There may be new side effects, or the treatment may not work. In some types of trials, you may not get the new treatment—you could be in the group that gets standard care, rather than standard care plus the new treatment.

But there are many possible benefits, too. You may get a treatment that works well. Even if the treatment does not help, you are contributing to the greater good by advancing research for the next pancreatic cancer patient.

Your doctor or the researchers can outline the short-term and long-term risks and benefits, as well as any other options available to you.

Cancer treatment costs are often covered by health insurance. There are also research costs related to taking part in a clinical trial. Often these costs aren’t covered by health insurance, but they may be covered by a trial sponsor. In many instances, there are no additional costs to participate in a clinical trial. In addition, the institution running the clinical trial may cover the patients’ costs.

Be sure you fully understand the financial implications before beginning the trial. It is beneficial to ask some questions about the cost of participating in a trial:

• Who pays for study drugs or treatment
• If participants pay, what is the cost
• Are there costs for the extra tests to monitor the trial
• Will your health insurance help cover costs
• Is there someone who can help you navigate this issue

There are two different aspects to safety in a clinical trial: safety of the trial, and safety of the participants.

A clinical trial must pass many safety hurdles before the researchers can start recruiting participants. All trials must be reviewed by an institutional review board (IRB) made up of people from the local community, including doctors and clergy, as well as people from the sponsoring institution. The IRB reviews and monitors medical research involving people to ensure the least possible risk to participants and that the risks are reasonable in relation to the expected benefits. There are also data monitoring committees and U.S. Food and Drug Administration (FDA) inspections of records, clinics, and research sites.

Participant safety is monitored by the research team, which must follow strict scientific guidelines and ethical principles. Trial participants receive high-quality, individualized care, and are closely monitored for treatment response, health, and any side effects. The FDA also has a role in protecting volunteers and making sure that the studies are done properly.

The FDA requires all participants go through a process called informed consent. Informed consent gives participants complete information about the study before agreeing to take part. Members of the research team explain the details of the study and provide an informed consent document that includes details such as purpose and length, describes any tests or procedures that will be done as part of the research, the risks and potential benefits of the trial, and who to contact for any further information.

As a participant, you will be asked to read and sign an Informed Consent Form, and you will be given a copy of the signed form to keep with your other medical records. This form must be written in a way that is understandable to the general public, so that you can understand the information when you sign it. However, the Informed Consent Form is not a contract. You may leave the study at any time and for any reason. In addition, informed consent is an ongoing process. You have the right to be given all pertinent information and have questions answered at any time during the clinical trial.