Why should I participate in a clinical study?
- Taking part in a research study can present you with other treatments or options that may not otherwise be available to you. Many of the studies have not been approved by the FDA yet and are not available to the general public.
- Participation in a research study may not help you but the knowledge gained from the trial may impact future generations.
What do I have to do to qualify?
- Every research study has specific inclusion/exclusion criteria to determine if you qualify to participate. Your doctor along with the research team members will review these criteria as part of an initial screening. Criteria can include general information like your age or race as well as health conditions, procedures, medical history and medications that you are currently taking.
What does it mean when a study is “blinded”?
- “Blinding” means that one or more people involved won’t know what drug or device (investigational product) is being used. This is done to prevent bias towards the investigational product. In some studies everyone is blinded including you as the participant, the study doctor and the study team. In other studies some of the study team are “unblinded’ and others are “blinded”.
- The study team will discuss with you what the conditions of a particular study are.
What does Randomization mean?
- Randomization is the determination of what treatment assignment you will receive. It is like a coin flip, heads you get the investigational product, tails you get placebo. It is done by a computer and generally everyone is blinded to which assignment you will receive. The study team and your doctor are unable to influence which assignment you get.
Why is there a placebo?
- A placebo is used as a comparator to the investigational drug. In order to show that the investigational drug is effective there needs to be something to compare it to, therefore a placebo is used. These studies are “blinded” and you won’t know if you are getting the placebo or the investigational drug. In some cases a similar drug is used as the comparator, the study team will let you know.
What are the potential risks?
- Every research study has an informed consent that will be discussed at length before you decide to participate. The informed consent will go into detail about what the risks are for that particular study. You will have time to discuss these risks with the study doctor.
- Because research studies involve investigational products there may be risks that are unknown.
Who are the members of the study team?
- The Principal Investigator (PI) is the doctor that is responsible for the conduct of the study at our site. They may delegate tasks to other team members to assist in managing the details.
- A Sub-Investigator (Sub-I) are other doctors or advanced practice members who assist the PI in performing the tasks outlined by the study.
- A Clinical Research Coordinator (CRC) is a person who handles most of the administrative responsibilities of the study. They manage the day to day details including data collection and entry, informed consent, patient visits and scheduling.
Will I get paid for participating?
- Many of our studies require the participant to return to the clinic for scheduled research visits. For these visits we offer a small stipend to cover travel and time expenses. The amount and how often will be explained during the consent process.
How long will my participation last?
- Every study is different, it might as short as 1 day or as long as 10 years. The time frame will be discussed during the consent process.
Can I stop the study if I want to?
- Absolutely! Participating in a research study is voluntary and you are not obligated to continue if you are unwilling or unable. We hope you won’t want to withdraw but if you need to you may be asked to sign a form designating any future involvement.
What are the different phases of research?
- Phase I – Initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
- Phase II – Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks
- Phase III – Expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide an adequate basis for physician labeling.
- Phase IV – Post-marketing studies to delineate additional information including the drug’s risk, benefits, and optimal use.
What is an IRB?
- The Institutional Review Board (IRB) is responsible for safeguarding the rights and welfare of human subjects by reviewing and approving the protocol and informed consent by following the FDA rules. It is made up of a group of medical and non-medical professionals. This group is also required by the FDA to do periodic review of ongoing research studies.