One of the most important goals of the researchers who conduct clinical trials is to protect the safety of the clinical trial participants. To ensure participants’ safety there are several protective steps that researchers must follow when conducting clinical trials.
Protocol and Informed Consent
Each clinical trial must have a unique action plan called a protocol. The clinical trial protocol is a study plan that contains complete details about the trial including the background and reasoning for the trial, study objectives, trial design, methods and statistical considerations. The protocol describes what types of people may participate in the trial and details the schedule of tests, procedures, medications and dosages. Its purpose is to ensure that the study is justified, safe for participants and designed to allow the research questions to be answered. Because of the careful design of treatment protocols, clinical trials are the safest and quickest way to confirm whether new treatments are truly beneficial for patients.
Part of the clinical trial protocol is informed consent. Informed consent is a process required by the FDA that ensures patients are given complete information about a clinical trial prior to their participation. In order 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 is started. This ensures that every participant understands his/her role and rights in the trial.
The key facts of the study are included in a written informed consent form for participants to read and discuss with their families and doctors. The FDA requires that the informed consent 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 and 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
- Guarantee that participants have the right to leave the trial at any time
- Contact information in case the participants have questions about the trial or experience side effects or problems during the trial
The patient has the right to ask questions about any aspect of the clinical trial if he or she does not understand the information being presented.
Institutional Review Boards and Data Safety Monitoring Boards
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.
To further ensure the safety of participants, a Data Safety Monitoring Board (DSMB) is commonly used. The DSMB is an impartial group that monitors the progress of clinical trials. They are not involved in the trial in any other way. They ensure 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 Pancreatic Cancer Action Network maintains a comprehensive database containing up-to-date information about all pancreatic cancer clinical trials taking place in the United States. Through our Patient Central Associates, we offer personalized clinical trial searches so that patients can find trials for which they may be eligible.
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The Pancreatic Cancer Action Network recommends that all patients consider clinical trials when exploring treatment options.
Clinical trials overview
Learn about pancreatic cancer clinical trials
How does a new treatment get FDA approval?
Common concerns about clinical trials
Benefits and considerations