5 Reasons Why Clinical Trials Are Safe

Patients with pancreatic cancer who participate in clinical research have better outcomes. Every treatment available today was approved through a clinical trial. PanCAN strongly recommends clinical trials at diagnosis and during every treatment decision.

Even so, the PanCAN Patient Services team hears many questions and concerns from patients and caregivers about clinical trial safety. Rest assured, patient safety is a top priority in all clinical trials, and patients have rights that protect them. Our Case Managers want to make sure every person facing a pancreatic cancer diagnosis has the support and information they need to make an informed decision about clinical trial participation.

Below is a list of the five top reasons why clinical trial participation is safe.

1. Patients provide informed consent.
   Before participating in a clinical trial, patients must sign an informed consent form. Providing informed consent means that the patient is comfortable with the logistics of the trial, including the treatment regimen, predicted duration of the trial, any additional testing necessary and potential side effects. Before signing an informed consent form, it's important that the patient ask as many questions as they can - including gathering questions and concerns from caregivers and other loved ones. For questions to consider asking as you explore clinical trials, contact PanCAN Patient Services. Our Case Managers can provide a list of suggestions and talk through any concerns about the process.
2. Clinical trials have specific eligibility criteria.
   Trials are carefully designed to specify which patients can and cannot participate - to maximize the information that can be gathered, to ensure that the investigational treatment is given to patients most likely to respond and to make sure the trial is conducted safely. Information taken into consideration typically includes type and stage of cancer, prior treatments received and medical history. Participation in a clinical trial also usually requires a good level of physical functioning and good major organ (liver, kidney, heart) function.
3. Download our comprehensive Clinical Trials booklet for more information about clinical trial safety, the enrollment process, questions to ask and more.
4. Patients are carefully monitored.
   Patients in clinical trials receive care and close monitoring by top doctors and researchers. The study healthcare team will discuss the anticipated side effects that may be experienced due to the experimental drug. It is important to understand all cancer treatments, including standard treatments, may cause side effects. The degree to which a patient experiences side effects can range from mild to severe. However, side effects can be successfully managed with the help of the healthcare team. In addition, patients can choose to discontinue their participation in a clinical trial at any time, for any reason.
5. Patients will never receive a placebo, or "sugar pill," in lieu of standard of care.
   A common fear for patients considering clinical trials is that they will receive a placebo. A placebo is a pill that does not contain active medication. Sometimes it is referred to as a "sugar pill." In cancer treatment clinical trials, placebos are never used in place of treatment. All patients on clinical trials will receive either the experimental treatment or the best-known standard treatment.
6. Patient safety is everyone's priority.
   Any institution that conducts clinical trials is required to have the trials reviewed and approved by its Institutional Review Board (IRB) before participants can enroll. This 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.

   PanCAN Patient Services is a partner for patients and their loved ones as they consider clinical trials as a treatment option. Our Case Managers can perform personalized clinical trial searches based on individual needs and medical history as well as talk through any questions or concerns.