Ensuring patient safety should be a top priority in any clinical research trial. All involved must come together to work toward a solid systematic approach that monitors and maintains appropriate safety standards for patients throughout every phase of a trial. Furthermore, it is also the responsibility of administration and doctors to communicate these safety practices clearly and effectively so that patient participants are made fully aware. It is important that participants know what to expect throughout a trial and what options they have at any given point. Patients should be receiving these messages at every step of a trial, from recruitment to completion. Trust is essential in the relationship with patients, so you need to make them feel at ease.
Understanding Trial Approval
Patients can better trust that they will be safe while participating in clinical research if they understand that trials are rigorously vetted and monitored. Clinical trial doctors and staff are all obligated to abide by strict rules and protocol. These are in place to keep patients as safe as possible. Before a clinical trial team can even begin recruiting patients, it must be approved by an Institutional Review Board (IRB). Each IRB is a group of clinical research experts that make sure a trial is designed correctly and can be carried out safely. Every clinical trial involving human volunteers is closely monitored by an IRB throughout the duration of its run to ensure continued safety.
In addition to IRB approval, a clinical trial needs to get permission from the Food & Drug Administration (FDA) before it can begin. This institution protects participants throughout the clinical trial process by working closely with researchers to make sure that trials are safe. To get this FDA permission, study sponsors submit an application detailing the data of their early research and showing that they have taken every step to ensure patient safety before starting recruitment. Patients can be assured that only the best research studies are allowed to continue to clinical trial.
Understanding the Research Team
The doctors and staff that comprise the research team are there for patients during every step of a trial to ensure that safety practices are upheld and that patients are comfortable with the process. It should be made very clear to patients that the research team will help them understand everything that goes into being a participant, including:
- All of the treatment options (including those outside of the trial)
- What treatment is being researched in the study and why
- Both the risks and benefits of patient participation
- Treatment schedule and required visits
- Contact information of staff for questions or concerns
- Privacy policies in place to protect patient information
- Right to leave the study at any point
This last point is particularly important. Patients should be made fully aware that participation is voluntary and they have the freedom to withdraw at any time for any reason. The transition may be quick or more drawn out, depending on the research being done, but patients will always have the ability to return to standard care afterward.
At each and every stage of the clinical trial process, prospective and current patients need to know that they are heard and that their safety is the priority. Be open, be welcoming, and put in the effort to create top-notch patient safety communication protocols.
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