Below are answers to frequently asked questions.
Click on each one you would like answered. Also, feel free to call us.
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 effective 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: 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 most 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.
A: All new medications must go through clinical trials before they are allowed to be broadly prescribed. While clinical trials are not for everyone, every study volunteer makes a personal commitment to participate, often for the good of all sufferers to have new and better treatment options. That being said, every single volunteer receives a high degree of medical care that typically can’t be found within normal patient practices. Studies are all reviewed and approved by the regulatory agencies and are highly regulated in terms of how they are conducted. At any time, a study volunteer is able to stop participating. It’s totally within their control. Most of our studies are phase III or IV which means that the drug has already gone through 2-3 phases of testing with hundreds or even thousands of patients already.
A: The Pharmaceutical sponsor and ethical review board set the compensation. Unfortunately we can’t alter the amount.
A: We have a handful of physicians who have a flexible schedule that can work around your schedule. We will do our very best to accommodate you.
A: Luckily we are close to an NJ Transit Train Station. We are located about 4 blocks away from the Raritan Train Station, which is on the Raritan Valley Line that passes through Newark Penn. We are the stop after Somerville. Once exiting the train, walk South on Thompson St. Make a left on East Somerset St. After about one block, you should see a TD Bank or Shell Gas Station. Our parking lot and entrance are located in the back of the building.
A: Each study medication typically lists known side effects and the amount of people seen with side effect within the Informed Consent.