Frequently Asked Questions
Below are a few of the most frequently asked questions we hear. Of course, you may have further questions and we understand. The staff of the Clinical Research and Education department will make sure you are fully informed and understand the study.
Is Research Safe?
– Clinical research has inherent risks and potential benefits. By phase II, researchers may have some initial idea of what type of adverse events patients are seeing. The more patients that enroll in research studies give a better idea of what type of adverse events may be seen with a particular medication. It is important to note that Pharma companies are required to report all adverse and serious adverse events to the FDA, no matter how few patients actually had the event. Prior to participating in a clinical research study, your doctor will go over, in detail the potential risks involved.
How does the placebo thing work?
– Many trials are placebo controlled meaning the drug is getting tested against a “sugar pill”. A patient in a placebo controlled trial certainly has a possibility of getting placebo but generally has more possibility of getting drug. Important to note that patients in clinical trials are followed more closely than regular patients. Patients that are not doing well in a trial on placebo will often be switched to the study medication.
What if I’m not doing well?
- Patients in clinical trials are followed more closely than regular patients. Those who are not doing well in a trial on placebo will often be switched to the study medication. Those who are not doing well on the study drug may be dose escalated or often discontinue the clinical trial.
Will I still see my current Doctor?
– Only if your current doctor is an investigator on the study for which you are a candidate. Otherwise, your research team will be in close communication with your current doctor to aid in an easy transition once the study is complete.
Who pays for everything?
– Many clinical trials are funded by pharmaceutical companies. Though the Pharma industry funds the studies, they are carried out by other groups to maintain fair balance. The US FDA oversees and regulates all studies involving human subjects.
Do I have to have insurance / does insurance get billed?
– While participating in a Pharma sponsored clinical trial all visits, study related procedures, and study related therapy are paid for by the Pharma sponsor. A patients insurance should never be billed for study related visits. In the event a patient has a second diagnosis, not part of the study, the patient or their insurance will be responsible for those visits.
Will I get paid to participate?
– No, you will not be paid to participate, however you may be reimbursed for your time, travel etc.
How much time will it take?
– This depends on the study. Some studies require a short visit every week while others require a longer visit every month. Study visits may last 15 minutes or as long as several hours