Clinical trials are research studies designed to test whether a specific treatment or medication is effective for a specific disease or disorder. Their goal is to help research teams understand the safety and effectiveness of these treatments/medications, evaluating side effects, benefits, and risks of each treatment/medication.
All participants in a clinical trial are volunteers who should understand the potential benefits and risks of the trial. The team of doctors, nurses and study staff are experienced to follow the strict rules in place to keep your health and privacy safe while participating in a clinical trial.
Clinical Trials and Tests Are Safe for Clinical Trial Participants
By the time a clinical trial is available for people to take part, the treatments or medications have been evaluated extensively. Each clinical trial goes through rigorous evaluations and is reviewed by an institutional review board (IRB) to ensure there are safety guidelines and rules in place to ensure safety as much as possible.
According to the FDA, an institutional review board is, “a group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, IRBs have the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.”
It is almost impossible for a treatment or medication that has significant risks to make it to the human stage of testing. Even though the goal is to develop medications/treatments that improve the quality of life of participants, there are still risks associated with study participation.
As such, you will be under the supervised care of trained Principal Investigators and medical providers who will do their utmost to ensure your safety throughout the research study. If necessary, you may also opt-out of a study at any point in time since it is a voluntary process.
How a Clinical Trial Works in Practice
When a new treatment or medication is developed by a team of scientists, doctors, and other medical professionals it must first go through a rigorous and transparent research process to determine efficacy and safety, as outlined by the Food and Drug Administration (FDA).
An important step in this process is when a new treatment can advance to the human stage of testing. Patients for whom the new medication or treatment is designed for, must meet specific requirements, such as being a specific age, gender, having certain health conditions, and more.
A list of inclusion and exclusion factors is used to decide who is eligible to participate. This is a critical component of the selection process because it ensures people who might have a negative reaction or who are at a higher risk of side effects are kept out of the study. Clinical trial teams do their utmost to always ensure patient safety during a study.
When you have undergone evaluation and are determined to be a good candidate for a clinical trial, you must then go through the informed consent process. You must evaluate the informed consent document carefully before deciding to participate in the trial. This ensures that you fully understand purpose and design of the study, along with responsibilities of trial participations and any potential risks or side effects.
Once you have read through the documents and decided to participate, and if you are chosen to participate, then the clinical trial begins. Depending on the trial, the phase the trial is in, and the treatment/medication being evaluated, it can take anywhere from several weeks, months or years for the trial to be completed.
Learn More About Clinical Trials in Boston
Are you interested in participating in a clinical trial? We have a wide variety of clinical trials available. You may qualify if you meet specific criteria.