Editor’s note: In honor of Patient Safety Awareness Week, March 10 – 16, we wanted to provide some information and reassurances about the safety of participation in pancreatic cancer clinical trials.
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 (PanCAN) strongly recommends clinical trials at diagnosis and during every treatment decision.
Below is a list of six top reasons that clinical trial participation is safe.
- 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. Patient Central Associates can provide a list of suggested questions that could be helpful to ask.
- 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 treatment is given to patients most likely to respond and to make sure the trial is conducted safely. Types of criteria for clinical trial eligibility include the patient’s diagnosis, prior treatments received and other relevant clinical features.
To take that personalization a step further, pancreatic cancer patients can undergo molecular profiling through their treating institution or PanCAN’s Know Your Tumor® precision medicine service, to determine the biological characteristics of their tumor. A list of treatment options, including applicable clinical trials, will be provided to all participants and their healthcare teams.
- Patients are carefully monitored. Throughout clinical trials, patients are carefully watched and encouraged to share any new or worsening side effects that they experience. The investigators must gather this information as part of their eventual application for drug approval and – even more importantly – the healthcare team can alleviate side effects or adjust the treatment to make the patient the most comfortable and safe.
- Patients will never receive a placebo, or “sugar pill,” in lieu of active treatment. A common fear among prospective clinical trial participants is that they will receive a placebo instead of a treatment agent that can help extend their life. At minimum, all pancreatic cancer clinical trial participants will be given a standard of care treatment. The only instance in which a pancreatic cancer patient may receive a placebo in a trial is when it’s administered in combination with a standard treatment option.
- Clinical trials do not cost extra money. In addition to physical safety, patients are also often concerned about excessive financial costs and insurance coverage. There are two types of costs associated with clinical trials – patient care costs and research costs. Patient care costs, or routine medical care costs, are related to treating your cancer and are mainly covered by your own insurance. Research costs are those related to taking part in a trial, which are covered by the trial’s sponsor. Patients are strongly encouraged to discuss costs with their healthcare team before signing an informed consent form and enrolling in a trial.
- Patient safety is everyone’s priority. In order for a trial to be conducted, it first must go through rigorous scrutiny by an institutional review board (IRB) to make sure the trial is feasible, safe and designed in a way to gain valuable knowledge about the drug or drug combination being tested. In addition, patients can choose to discontinue their participation in a clinical trial at any time, for any reason.
PanCAN strongly recommends clinical trials at diagnosis and during every treatment decision. It is important to know that patient safety is a top priority in all clinical trials, and patients have rights that protect them.