A: We collect personal information on our study participants including name, address, email, phone #, photo ID, etc. This information is entered into an encrypted database and is only able to be accessed by our study staff. The pharmaceutical sponsor and study monitors never see or have access to a patient’s personal information. All data that we collect from you during the study is linked to a patient ID number and is reported back to the sponsor, FDA, and others with that number. Your data will only be linked to your number. The privacy policy outlined in many study consent forms is part of the federal HIPAA consent that all medical offices use when they treat you. The “health information” that is shared refers to data like your lab results, weight, height, and other diagnostic results but not your name, address or personal information. They (pharmaceutical company or FDA) will have access to your data but there will be no way for them to know who’s data they are looking at.

A: At Amici Clinical Research the health and safety of our patients is our #1 concern. You do not receive study medication in any of our trials until we complete a thorough screening to determine that you are a good candidate for the medication. For many of our studies, like NASH (non-alcoholic steatohepatitis), there are no treatment alternatives that are FDA approved and on the market. For other treatment indications like migraines, high cholesterol, or osteoarthritis pain we are looking for study participants who have tried currently approved medications but are not getting adequate relief. If your disease or set of symptoms meets the study criteria, taking part in the study might offer you a benefit to treat your disease that you would not have if you were not a part of the study. At any time during participation if you decide that you cannot fulfill the study commitment or do not like the way the study medication makes you feel you can withdraw your participation. In the same respect if we have any indication that taking the study medication is no longer in your best interest based on the results of the study testing we would take you off the study medication. In some cases, even after stopping study medication the study may have provisions for continuing to monitor your disease at no cost to you or your insurance.

A: Many clinical trials involve the use of a placebo that looks like the study medication but has no active medicine in it, and often the study patient and study team will not know which patients are taking the medication and which patients are taking the placebo. The purpose of this is to get accurate data to confirm that the study medication is safe and affective without any bias. All clinical trials are reviewed by an ethics committee to assure that the risks of using a placebo in a clinical trial will not put any study patients in danger. All study patients are monitored closely and if a patient in a study requires approved therapy in addition to the study medication or placebo it is provided. Patients receiving placebo during a study will receive close monitoring of their condition typically with no cost to them or their insurance and even if they are not being treated they are helping to obtain more information about their disease both for themselves and for others.

A: In most cases study procedures are paid for by the pharmaceutical company sponsoring the study. Those procedures and tests are done at no cost to you or your insurance. In some cases you may be paid for your time and travel during study participation with a stipend after each completed visit.

A: Pharmaceutical companies sponsor studies in order to collect data to present to the FDA for drug approval. The pharmaceutical company with guidance from the FDA develops a protocol which is a document that details every aspect of the study conduct. The protocol defines the population of volunteers who can participate with specific inclusion and exclusion criteria. Most studies require that potential volunteers undergo some type of screening to assure they meet all inclusion criteria and no exclusion criteria before they are officially enrolled in the study or start study medication.

A: We encourage potential study volunteers to discuss their decision with their physicians and family prior to becoming part of a clinical trial. In most cases we can provide an informed consent document in advance of your first visit that outlines the study which can be read and shared with all of those involved in helping to make the decision. We also encourage participants, family members, and physicians to reach out to our study team of physicians and other healthcare providers to ask questions and discuss concerns before coming in for a first study visit.

A: All studies have a principal investigator, usually a physician, that oversees each trial and all volunteers who participate at a specific location. The principal investigator along with a study team of other healthcare professionals see you for your study visits. You will continue to follow up with your own doctors while you are in a study. Your doctors and the study team can communicate (if you give permission) to assure you are getting the best care.

FAQs

CLINICAL RESEARCH

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