Clinical trials, also known as research studies, are conducted in people with the goal of understanding more about a medical, surgical, or behavioral intervention. These studies are conducted by drug companies and research sites.
We need these studies in order to find new therapies or treatments that are safe and effective for people. Without volunteers for these studies, there would be no new medications.
The study-related medication, as well as study-related care will be provided to you by the research staff at no cost throughout your participation in the study.
Other than your time, there will be no cost to you. Additionally, during any clinical trial you will be compensated for your time and travel.
Clinical research studies in the U.S. are regulated by the Food and Drug Administration (FDA). Each study must undergo diligent reviews and follow a set of strict rules. All medications have side effects, and as a result, the participants’ health is monitored closely and frequently by the research team.
All of this is put into place to ensure that the rights, safety, and well-being of participants are protected during the study.
In addition to the FDA, an Institutional Review Board (IRB) is responsible for approving every clinical trial in the U.S. The IRB is a group of doctors, scientists, and lay people that are dedicated to ensuring that the health and safety of participants are put first.
First, a research staff member may speak to you over the phone to confirm your interest in the study and ask questions to determine if you meet specific study criteria.
Afterwards, a screening visit may be scheduled in order to confirm your eligibility for the study. During this visit you have the opportunity to meet the medical doctor and research staff to discuss your medical history and review the informed consent. If you choose to participate in the study, the team will guide you through specific study procedures in order to finalize your eligibility for the study. The study team will explain all benefits and risks of study participation during the Informed Consent process. This is also an opportunity for you to ask any questions you may have before signing the consent form.
Once it is determined that you are eligible to proceed, you will be randomized into the trial.
You will continue to come in for visits and your health will be monitored until the end of the study. After the clinical trial is complete, the researchers will analyze all of the information collected. This can take a while; you usually do not get to know your individual results.
When participating in a clinical trial it is possible that you will receive a new treatment for a disease before it is available to everyone.
You are able to play a more active role in the management of your own health.
The research team may provide you with more frequent health check-ups as part of your treatment.
The new treatment may cause undesirable side effects or be uncomfortable.
The new treatment may not work for you, or there is a chance that it may not be better than the current standard treatment.
The time spent traveling or participating in appointments during the clinical trial may be an inconvenience.
You can withdraw from the study at any point in time.
The research team, including medical doctors and research staff, will continuously monitor your health throughout the study.
When volunteering for a study, you may be helping people in the future who share the same diagnosis.
During the study it is important to follow all of the instructions given to you by the study doctors and research staff.