Q: How does a trial work?
A: New treatments are developed and tested in the laboratory. After the laboratory testing, it moves on to clinical trials. Three phases of trials are conducted to ensure the treatment is safe and effective for patient use. Sometimes there is a 4th phase with a larger number of participants to asses how well the treatment is tolerated long-term. EMR mostly works with phase 2 and 3 trials.
Q: What happens after I enroll and pass the pre-screening?
A: Once our Research Coordinator contacts you to do a pre-screen, you will meet with both the Research Coordinator and study doctor at the designated site location. During this visit, we will go over the Informed Consent Form, schedule of events, concomitant therapies, . This will make sure that you are a good fit for the trial. Once the doctor has determined that you meet all of the eligibility requirements, you will be randomized into the study! You will have regular meetings with both the study doctor and Research Coordinator to monitor your progress and ensure your safety.
Q: How much does it cost?
A: All study-related appointments, medications, lab work, and any other procedures are provided at no cost. We actually pay you!
Q: How long are trials?
A: Each trial has a different time frame. Trials can anywhere from 16 weeks to 5 years!
Q: What is a placebo?
​A: A placebo is an inert substance (injectable, tablet, etc.) that does not contain any of the ingredients that are in the medicine being tested. Drug companies must show the new drug works better than the placebo.
Q: Are clinical trials safe?
A: All of our clinical studies are FDA and IRB approved.
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The study may require more time and attention than standard treatment would, including visits to the study site, more blood tests, more procedures, hospital stays, or complex dosage schedules.
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Most clinical trials pose the risk of minor discomfort, which often lasts only a short time. However, some study participants experience complications that require medical attention. In rare cases, participants have experienced serious or life-threatening complications resulting from their participation in trials of experimental treatments.
Q: What is the IRB?
A: The Institutional Review Board (IRB) consists of a group of doctors, scientists, researchers and people just like you. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.
Q: Do I need a doctor referral?
A: Good news! Doctor referrals are not needed.
Q:What are the benefits of participating in a trial?
A: There are many benefits to participating in clinical trials!
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You will be gaining free early access to treatments not yet available to the public.
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You may have direct access to specialists who may otherwise be difficult to schedule with.
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You will be changing lives by contributing to medical research.
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You will receive compensation for your time and travel.
Q: What is an Informed Consent Form?
A: This form is used to provide subjects with the information they need to make a decision to volunteer for a research study. You will receive this form before any study-related procedures are performed.