Excel Medical Clinical Trials

Frequently Asked Questions (FAQ)

What Are The 4 Phases Of Clinical Trials?

Phase 1

Phase I trials assess a medication’s safety. These trials also evaluate what the drug does to our bodies as well as what our bodies do to the drug. These effects are called pharmacodynamics and pharmacokinetics, respectively. This first phase of testing in human beings is performed in a very small number of healthy volunteers who and are ordinarily remunerated for their participation. A phase 1 trial will also investigate side effects and benefits that occur at various dosages. Phase 1 trials typically take several months to complete.

Phase 2

After phase 1, when a medication has been shown to be safe, it is then further tested for efficacy. Phase 2 trials can take months to years to complete, and can involve several hundred subjects. These trials are typically “randomized”, meaning that people are spit into two groups, those who receive the drug, and those who receive a placebo.

Sometimes these trials are “double blinded”; neither the patient nor the researcher knows who is receiving the real medication. This enables the trial to be unbiased, producing more accurate results.

Phase 3

In a phase 3 trial, a drug is tested in many more people, typically hundreds to even thousands. With such a large group being studied, both pharmaceutical companies and the FDA gain a better understanding of the medication’s effectiveness, as well as its potential to trigger adverse reactions. These trials are usually both randomized and double blinded, and can last several years. After a phase 3 trial has been successfully completed, pharmaceutical companies can request FDA approval to market the drug.

When such a trial successfully gains FDA approval, it is often known as a “pivotal” phase 3 clinical trial.

Phase 4

Phase 4 trials are performed with FDA approved medications in order to learn even more about an approved medication.

Should I Join A Trial?

Joining a clinical trial can be an exciting event. It does, however, require thought and consideration. It is even advisable for people to speak with their physicians prior to joining a clinical trial. Interestingly, most people who enter a clinical trial do so to help others, and to help themselves. Doing so also affords participants the opportunity to take a medication prior to its availability to the general public. Many trials provide participants with “stipends”, money that compensates you for your time and willingness to participate.

Additionally, when people join clinical trials, clinicians will very carefully monitor them. The Principal Investigator of a trial is a physician who has very vigilant oversight over you and the entire clinical trial at his/her site.

At Excel Medical Clinical Trials, LLC we differentiate ourselves by being a consortium of carefully vetted clinicians, rather then businessmen/women, or even simply scientists. We have extensive experience caring for and treating real patients and bring this experience to all of our trial participants.

It is vital that you understand your rights and protections when joining a clinical trial. For Excel Medical Clinical Trials to be given the right to participate in a clinical trial, it requires not only the scrutiny and approval of the study sponsor, but also the approval of an Institutional Review Board (IRB). IRBs ensure patients’ rights are protected and that studies are performed with patients’ rights and safety as the top priority.

Additionally, prior to joining a clinical trial you will be asked to sign a consent form. Consent forms exhaustively review your rights and risks, and ensure that you can leave a clinical trial if ever you want. In sum, your rights are paramount when you join a clinical trial.

For more information about clinical trials, please consider visiting one or more of these websites:

www.clinicaltrials.gov

www.clinicaltrials.com

www.ciscrp.org

https://www.nih.gov/health-information/nih- clinical-research-trials-you

https://www.nih.gov/health-information/nih- clinical-research-trials-you/basics

www.centerwatch.com

What Does Joining a Trial Involve?

First, Prescreening:

This is the initial step in joining a clinical trial and occurs over the phone. During the call, one of our experts will speak with you. She/he will first describe the clinical trial that might suit you. She/he will ask you a series of questions to determine if the trial might be right for you. You of course are encouraged to ask any and all questions you may have. If you and the expert believe you are a good candidate for the trial, you will schedule a visit at our site.

Second, Screening at our site:

After an initial greeting, you will be asked to complete an intake form concerning your particular medical conditions, including medications. We may request that you complete a medical release form to enable us to communicate with your personal physician. This will enhance your safety when joining the trial.

Then we move to the informed consent. Informed consent is something we take extraordinarily seriously at Excel Medical Clinical Trials. This form details all aspects of the trial. Any reported study-drug side effects will be detailed. Informed consent also plainly states your rights. If, after you read the informed consent, discuss it with our research staff, and have all your questions answered you then determine that you would like to join the trial, you will sign the document together with our expert present. This process establishes the fact that you have been informed of potential risks and benefits of participating in the study, and that your questions have all been addressed to your satisfaction. After informed consent has been discussed and signed, we will move on to complete other steps in the process. This might include a physical examination by our physician investigator, obtaining blood tests, and taking a more extensive medical history. We may also perform an ECG.

Third, Following the Protocol and Scheduling visits:

It is imperative that we follow the trial’s protocol. If after the screening has been completed and you are deemed eligible for enrollment in the trial, you will be asked to return to our site for randomization. This means that you will be placed in a particular “arm” of the trial, independent of the influence of you or the site’s investigators. Study visits will then be scheduled. The goal is for each trial participant to:

  • Complete all scheduled study visits as detailed in the informed consent.
  • Honestly answer all questions regarding potential side effects
  • Take the Investigational Product (IP) as agreed

Fourth, Completion

After you complete all scheduled visits, you will have successfully completed your part in the research trial. Often a final physical examination as well as blood tests will be performed on your completion of the trial.

At times you will be offered an opportunity to enter an “Extension” trial. This enables participants in the trial to continue taking the study medication for a longer time period. This is an excellent opportunity for trial participants, especially when the trial medication has been effective for you.

What Trials Can I Join?