What Type of Research Does Dr. Marsella Conduct?
Dr. Gregory Marsella has been a Principal Investigator in Phase II-IV trials for the past 20 years. He is currently performing Phase II-IV studies with Dr. Joe Arena at their research clinic, Da Vinci Research Institute.
Most of the studies performed by Dr. Marsella and Dr. Arena are Phase III-IV studies. They do research into pharmaceutical and medical devices for a variety of conditions. Some of the fields of research they are involved in are: psychiatry, neurology, internal medicine, infectious diseases, and rheumatology.
Is there any cost to participate in a clinical trial?
In Phase I-III studies, there are no costs for the volunteer to participate. Most pharmaceutical companies will provide a stipend for every visit to the research clinic to cover travel expenses and food. The amount of stipend generally ranges between $40-$60 per visit to the site. However, in some Phase IV studies, there may be costs associated with participating in an open-label, post-marketing study. These costs are generally greatly reduced from what it would cost to have the treatment prescribed by a doctor.
Does everyone receive active study drug?
Depending on the protocol (the rulebook, so to speak, for the study), you may be given active study drug. Most protocols require a comparison to judge the efficacy of the treatment being applied.
The comparison can be with a placebo (non-active treatment that appears to the be same as the active treatment), or comparison with one of more currently used treatments for the indication. Sometimes both methods are used.
What is an open-label study?
An open-label study is usually a follow-up study offered to volunteers that have participated in a randomized, blinded study of the treatment in question. They generally tend to last anywhere from 6 months to a year and all participants are given the active study medication.
Dr. Marsella tries whenever possible to offer studies that are followed with an open-label extension study, so that all participants who complete the randomized, blinded study are given an opportunity to take the study drug.
What is a randomized, blinded trial?
Most Phase II-IV studies are randomized, blinded trials. This means that the volunteer, and most frequently the doctors and the study staff, are not aware of who is receiving the actual study drug. Participants are randomly selected by computer software to determine what medication they will receive. Some trials randomize volunteers only at the start of study treatment, while other protocols randomly choose at every visit whether the volunteer will receive active study medication, placebo, or comparison medications.
If I think I might want to be in a trial, what should I do?
The first step required to participate in a clinical study is the Screening Visit. Patients who are known to the doctors have been recommended to apply for inclusion in one of their ongoing clinical trials. At the Screening Visit, the patient is informed about the trial, what is expected of them while in the trial, any side-effects that are currently known about the active study drug, and comparison drugs (if any). They are also informed about alternatives for treatment outside of the clinical study. Once a patient has been thoroughly informed about the trial and their options, has had all of their questions answered, and has been able to speak with the doctor about their possible inclusion in the trial, they sign an informed consent, agreeing to participate in the trial.
I have signed the Informed Consent. Now What?
Once informed consent has been given, signed, dated, and witnessed, the screening process begins. The screening process consists of a variety of medical tests. Almost all studies include, as part of the screening process, blood work, drug test, urine test, EKG, and a physical. In addition, study staff will collect medical records from your current and previous physicians, and receive a complete list of all vitamins, supplements, over-the-counter, and prescription medications. Depending on the treatment being tested, and the condition for which the treatment is being studied, additional testing will be required. For instance, in a trial testing a new antidepressant, some of the additional testing would include: a psychiatric evaluation, and various psychological assessments to determine the severity of symptoms, along with an evaluation to determine if there is a risk or history of suicidality.
Will I be chosen to enter study?
After all tests completed during the screening process have been returned and reviewed by the primary study doctor; all current and past medical documents reviewed; and all current and recent medications investigated, a decision will be made by the study doctors in concert with the sponsor (usually the pharmaceutical company manufacturing the treatment) whether it is safe, and whether you match the specific inclusion and exclusion criteria for participation in the treatment phase of the study.
At that time, if you are chosen to be included, more medical assessments will be conducted to get your ‘baseline’ (before study drug) values. At the end of the visit, you will be randomized to treatment or to open-label use of the study drug.
I want to stop the study med and drop out of the study. What am I supposed to do?
A study volunteer can notify the study staff and doctor at any point during their participation that they would like to terminate the study early. The study staff and doctor will immediately order a final round of blood work, EKG, and other study related assessments and medical care to ensure your safety in exiting the study. It is advisable not to discontinue any study medication without first consulting with the study doctor as there may be specific instructions you need to follow to safely terminate the medication. Additionally, the doctor will want to monitor your test results before initiating discontinuation, and once you have completely stopped the treatment for study data purposes. It is extremely important, that even if you feel you are unable to return for the early termination procedures that you return any and all unused study material to the study staff. This includes, EMPTY study medication containers. The FDA requires stringent oversight on all study medication, and study staff is required to send EMPTY containers back to the pharmaceutical company for audit purposes both with the sponsor, with the FDA, and with the IRB for the study.