Frequently Asked Questions

A clinical trial is a research study of medical treatment in volunteer patients, also referred to as participants. Clinical trials are used to learn if treatments are safe and effective to treat or prevent medical conditions and understand if new therapies can improve quality of life. The data from clinical trials is needed to support the approval of new treatments by the US Food and Drug Administration (FDA) and other similar agencies worldwide.

Clinical trials are led by a doctor, nurse, social worker or other medical professional trained to conduct clinical trials properly, safely and ethically. The healthcare professionals running clinical trials are called Principal Investigators.

Clinical trials run in a controlled manner and follow protocols with set guidelines for each trial. The protocol defines how the trial will run, including treatments used, trial duration, participant evaluations and diagnostic tests collected from the volunteers.

All Principal Investigators and patients participating in a clinical trial follow the same protocol, so that all patients are treated consistently and equally. This allows for even the smallest of differences between treatments to be seen.

Deciding to participate in a clinical trial is a significant and personal decision. Joining a clinical trial is your decision, and you may drop out of a trial at any time.

Before you join a trial, you’ll meet with the Principal Investigator to discuss known risks and benefits of the treatment, the schedule of visits and tests required by the protocol and treatment options available in the protocol. The Principal Investigator will explain the protocol procedures to you in detail so you understand the schedule and know when to meet with the Principal Investigator or staff to provide new evaluations.

If you decide to join the study and provide written informed consent to participate, you’ll have diagnostic tests performed to see if you meet the criteria to be enrolled. Not everyone will meet the entry criteria, so not everyone can be enrolled.

The clinical trial protocol defines clinical trial participation requirements, and every patient must meet the requirements before enrollment. After you provide your consent to join a trial, you’ll undergo a series of diagnostic tests to see if you qualify.

If you qualify, you may be given a treatment to use during the trial. The protocol may require the treatment to be masked or blinded to prevent the false perception that one treatment is better than the other. If treatment is blinded, you may not know what treatment you receive.

You’ll participate in a series of medical and physical examinations to measure the effects of the treatment over the trial duration. Trial duration, clinic visits and testing schedules vary from protocol to protocol. Some protocol procedures may be done at the Principal Investigator’s clinic, and some may be completed by you at home.

At the end of the trial, data from your visits and testing will be collected, pooled with patients from other sites and analyzed to see if the treatment has a real medical benefit. The data you contribute during participation is very important to understanding treatment effects, so you’re encouraged to complete the trial to the end. Your data will be used to advance science and improve medical care for patients like you.

Please feel free to call one of our experienced study professionals to find out more about clinical trials. We’ll gladly answer any questions or concerns you may have and discuss the clinical trials we’re currently running.

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.

At IMA 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.

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.

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.

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.

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.