FREQUENTLY ASKED QUESTIONS
Deciding to participate in a clinical research trial is an important decision and the factors that influence this choice are different for each individual. The below section outlines answers to some of the more commonly asked questions.
If you are interested in pursuing a trial opportunity, please complete the Clinical Research Interest Questionnaire. If you have additional questions, please contact the clinical research office at (315) 261-6311 or email us at firstname.lastname@example.org.
What is clinical research?
Clinical research is a branch of healthcare which systematically and scientifically assesses new drugs, devices, and treatment regiments for safety and effectiveness in volunteer participants. Pharmaceutical and device companies partner with health systems like St. Lawrence Health System throughout the nation and world, to execute the same research protocol in multiple locations, resulting in standardized data that can help the US Food and Drug Administration (FDA) determine if the new treatment should be approved for use in a medical setting. Each clinical trial has a strict protocol that specifies which patients can be included in a trial and outlines every detail of the study, including the schedule of study appointments, the dosage of the investigational drug, and the tests and procedures that will be completed at each appointment.
How do I become involved in a clinical trial?
If you are interested in participating in a clinical trial, please reach out to the research department at (315) 261-6311 or at email@example.com, and let us know which category you fit:
- You are interested in one of our active studies (listed above)
- You are not currently diagnosed with one of the conditions listed above, but you are interested in participating in a clinical trial if one does become available that fits your medical history.
What happens when I participate in a clinical trial?
Each clinical trial protocol is different, but they typically follow the same sequence of events outlined below:
- Informed Consent: Before any study-specific treatments, tests, or procedures are performed, you will sit down with research staff to go over the informed consent form. This form is a detailed document that outlines all the information about the study and the study treatment. You will have as much time as you need to ask questions to the research staff and study physician, and to think about the decision before you choose to sign the consent form or not.
- Screening: If you decide to sign the consent form, you will enter the screening period, where we match your health information with the criteria for the study to determine if you are a good fit to participate.
- Treatment Period: If you are a good fit for the study and you are still interested in participating, you will enter into the treatment period, where you will attend study appointments at your physician's office, and receive study treatment as specified in the consent form. The length of your involvement varies for each study but is typically between 6 months to 2 years. The frequency of the study appointments is often monthly but can be more or less frequent depending on the study.
- Follow-Up: After the treatment period is over, you will typically have a couple of follow-up visits, where we check up on your health and work with you to come up with a treatment plan moving forward.
Screening and treatment procedures depend on the specific study, but may include blood work, electrocardiogram, pulmonary function test, chest X-ray, etc.
Can I stop participating in a clinical trial after I sign the consent form?
Yes. Participation in a clinical trial is voluntary, and you can stop participating at any time by notifying the research team. It is helpful, but not required to tell the research team why you have decided to stop participating.
What are the costs associated with participating in a clinical trial?
Every study is different; however, the pharmaceutical/device company that sponsors the clinical trial often provides the study treatment at no cost to you and pays for all research-related tests and procedures. Any routine tests or procedures, which are not related to the research study, will always be the participant's responsibility.
Depending on the study, there is often compensation available to cover the costs associated with your time and travel.
How is my safety protected during a clinical trial?
Clinical research is regulated by the ethical and legal codes that apply to medical practice, in addition to clinical research-specific federal regulations that protect the rights and well-being of research participants. Clinical research trials must be approved by an Institutional Review Board (IRB), which is an independent ethics committee that ensures that the potential risks involved in participating are worth the potential benefits. During the trial, all identifying information, like your name, phone number, and address, will be kept confidential, and only shared with people directly involved in the clinical trial, or as required by law.
Where can I learn more?
For more information about clinical trials, what to expect when participating, or for information about specific clinical trials being conducted throughout the world, check out https://clinicaltrials.gov/. The "For Patients and Families" section of the website may be particularly useful.