A clinical trial is a medical research study that evaluates the safety and effectiveness of an investigational drug or device. Clinical studies are necessary to determine whether or not potential treatments will be approved by the FDA for future use.

Participating in a clinical trial helps find answers that lead to discoveries in improved treatment options. In clinical trials, researchers evaluate investigational medications not yet approved by the U.S. Food and Drug Administration under carefully controlled conditions. Clinical trials are essential in bringing potential new treatment options to patient care and the advancement of medical knowledge.eceive placebo, you will not be able to get the actual drug at the end of the study, unless specified in the study protocol and consent form. There is no waiting list at our site to be put on to receive the drug once/if it is approved, but we encourage you to monitor the study on ClinicalTrials.GOV and you can see when the study data is published. Additionally, the pharmaceutical company (sponsor) of the study will issue press releases if the drug is approved. However, the drug approval process can often take many years to complete.

Every eligible study participant takes part in the informed consent process, which will explain the following in detail: the purpose of the study, the study design and procedures, what is expected of a study participant, the possible benefits and risks of participation, and how your personal is used and protected.

This process ensures that potential participants can have their questions answered and understand everything involved in the study to help them make an informed decision about participation. Participation in any clinical study is completely voluntary.

If you chose to participate, all study-related information will be clarified in the Informed Consent Form (ICF), which the study doctor will provide and explain to you. You will be asked to review and sign the ICF to indicate that you are willing to take part in the study.

All clinical trials conducted at Millennium Clinical Trials are overseen by highly skilled specialists and licensed physicians.  Our studies are approved to be conducted by the FDA and study oversite is maintained by various regulatory bodies and Institutional Review Boards (IRB’s) or Ethics Committees.  If qualified, you will gain access to a novel new, promising medication, not yet available to the general public, doctors, or other medical institutions.

In addition to assisting in the advancement of scientific and medical knowledge, treatments, and improving patient care, there are many other benefits in participating:

• Investigational drug and study-related assessments (i.e. x-rays, ultrasounds, DEXA scans, mammograms, EKG’s, biopsies, and more) at no cost

• Complimentary clinical laboratory (blood) and urinalysis testing

• Study-related medical monitoring by the highest quality, first-rate medical teams

• Complimentary physical exams

• Compensation for time and travel

• Medical Insurance is not needed to participate

• You do not need to provide your social security number or be a U.S. Citizen

Screening:

• Informed Consent Process

• Review of study eligibility in accordance with the Protocol’s Inclusion/Exclusion criteria

• Medical Consultation

• Medical History

• Physical Examination

• Review of medications you are currently taking and have taken in the past

• Vital Signs

• Blood and Urine Samples

*The above are basic study visit procedures typical of a standard screening visit.

Treatment:

If you meet all of the criteria required to take part in the study, you will enter the Treatment Period with study medication.

Most Study Treatment Periods are Double-Blind, Placebo-Controlled.  Double-Blind means that while the study is ongoing, neither you nor your study doctor (or his/her study staff) will know which study treatment group you are in.  However, if needed, your study doctor can quickly find out which study treatment group you are in – this is known as breaking-the-blind.

During Randomization, you will be placed into a study treatment group by chance (electronically generated – like flipping a coin).  You will either be randomized to receive active study medication or placebo.  The purpose of the Double-Blind Study Treatment Period is to compare the effects of the Investigational Product (IP) to those of placebo.  Placebo looks identical to the IP and is administered the same way but has no active drug in it.  Some studies do not have a placebo.

Throughout the Treatment Period you will maintain close contact with the study site through phone calls and regularly scheduled in-office study visits, where many of the screening tests will be repeated.

Typical scheduled Treatment Period study visits will consist of, but not be limit to:

• Administration of study treatment and supply to take home

• Investigational Product accountability

• A review of any symptoms or side effects you may be having

• Blood and urine sampling

 Follow-up:

You are always free to withdraw study participation, or discontinue the study medication, at any time, for any reason.  When you stop or complete study treatment, and have your End-of-Treatment visit, you will begin the last part of the study – the Follow-up Period.

The Follow-up Period is to check on your well-being and health.  During this period you will no longer receive the study medication, but your study doctor will continue to assess your health condition.  Until your End-of-Study visit (last study visit) you will still have scheduled study visit(s) in which many of the screening and treatment activities will be repeated.  At the end of the study, your study doctor and team will ensure that you continue to receive appropriate standard of care.