The Pancreatic Cancer Action Network’s Patient Central Associates hear many questions and concerns from patients and caregivers about clinical trial safety. The pancreatic cancer community is not alone in having these concerns. Clinical trial safety is an important topic for patients across all cancer types.
Rest assured, patient safety is a large part of the clinical trials process, and safety checkpoints are incorporated from start to finish.
The following information will help you understand the priority of safety measures in clinical trials including guidelines, informed consent, safety review boards and use of placebos.
Every clinical trial must follow a set of guidelines that are outlined in a research plan called a protocol. This plan includes details about the goals of the trial, which patients may participate and the schedule of tests, procedures, medications and dosages.
One purpose for including these details in the plan is to ensure the clinical trial is safe for participants.
Due to the careful design of protocols, clinical trials are the safest and quickest way to learn if new treatments are better for patients than currently approved options.
An important part of a protocol is a step called informed consent. This process ensures patients are given complete information about a clinical trial before they enroll.
Before any clinical trial testing or treatment can begin, a patient must read and sign an informed consent form. This confirms a participant understands his or her role and rights in the trial.
The informed consent form includes the following information:
- Trial approach (what will be done)
- Experimental nature of the trial (that the trial involves use of an unproven drug or device)
- Purpose of the trial
- Procedures involved
- Expected length of the trial
- What happens during the trial and which parts of the trial are experimental
- Possible benefits and risks of the trial
- Other treatments that might be considered
- Guarantee that identity will remain confidential
- Assurance that participants have the right to leave the trial at any time
- Contact information in case patients have questions about the trial or experience side effects or other problems during the trial
To fully understand their rights, patients and their families should carefully read the informed consent and ask questions about any part of the trial information they do not understand.
Safety and Review Boards
Clinical trials have safety and review boards to ensure safety guidelines are followed without creating bias for the trial.
Institutional Review Board (IRB)
Any institution that conducts clinical trials is required to have the trials reviewed and approved by an IRB before participants can enroll.
An IRB is an independent committee made up of scientists, doctors, advocates and community members who review and monitor clinical trials. These committees ensure that trial risks are reasonable and as minimal as possible.
Patients should always ask if a trial is IRB-approved. The informed consent should have a date stamp that indicates the date of IRB approval and/or the date that this approval ends.
Data Safety Monitoring Board (DSMB)
A DSMB is an impartial group that monitors the progress of clinical trials.
It ensures patient 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.
The DSMB can stop a trial if the treatment side effects or risks are too severe.
Placebo Use in Cancer Clinical Trials
In cancer clinical trials, placebos (“sugar-pills” or inactive medication) are never used in place of the best known standard of care treatment.
In some trials, a placebo may be added to the standard of care for comparison reasons. Participants are divided into two groups – the standard of care group and the new treatment group. The standard of care group receives the standard of care plus a placebo and the new treatment group receives the standard of care plus the new treatment being studied.
Before enrolling in a trial, participants are told if there’s a possibility of getting a placebo in addition to the standard of care treatment.
There are many factors to think about when considering enrollment in a clinical trial. For additional information, check out the previous Shedding Light on Clinical Trials articles for an overview of clinical trials and a deeper look at eligibility criteria.