- What is a clinical trial?
- Why should I participate in a clinical trial?
- Who sponsors clinical trials?
- What is informed consent?
- Do I have to pay for the medicine/visits?
- What is a protocol?
- What is a placebo?
- What is randomization?
- What is a double-blind trial?
- What is a single-blind trial?
- What is an open-label trial?
- What are the phases of clinical trials?
- Who can participate in a clinical trial?
- What should people consider before participating in a clinical trial?
- What are the benefits/risks of participating in a clinical trial?
- What if the study drug is not working?
- Will a psychiatrist see me at every visit?
- Will I be able to enroll if I have not been diagnosed before?
- Will I be able to enroll if I have a full-time job and my schedule is not really flexible?
- Do I have to stop taking my current medications to enroll in the study?
- What happens when I finish the study?
A clinical trial is used to determine the safety and efficacy of new drugs or treatments. Clinical trials aid in finding the treatment that works best for most people.
Participating in a clinical trial allows the individual to play an active role in their own healthcare, gain access to new treatments before they become widely available, and contribute to medical research.
Clinical trials are sponsored by a diverse group of individuals or organizations. Individuals may include physicians, foundations, voluntary groups, pharmaceutical companies, and medical institutions. Federal agencies such as the Department of Veteran Affairs and the National Institute of Health also aid in the funding of clinical trials.
The informed consent process helps the individual to learn key facts about the trial before deciding whether or not to participate. During the informed consent process, the coordinator reads verbatim the informed consent to the subject. The subject is allowed to ask questions at any time during the process. The subject is then given the opportunity to read the informed consent on his/her own. Ample time and privacy is given to the subject so that he/she may discuss any concerns without feeling embarrassed in front of the research team. Once the subject feels comfortable that they understand what the study entails, the coordinator will ask if the subject wishes to participate in the study protocol. If the subject agrees, they will then sign, initial, and date all required pages. The principal investigator or physician/ ARNP will then meet with the parent guardian and/or subject and discuss the protocol briefly and answer any lingering medical questions or concerns. A copy of the informed consent form is provided to the subject/parent. Subjects are consented prior to ANY study-related procedures being performed.
There are no costs in screening for or participating in the study. If you qualify the study drug is provided to you at no charge. There is also no charge for the office visits with the physician. You do not need insurance of any kind to participate in the trial.
A protocol is a study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.
A placebo is an inactive pill, patch, liquid, or powder that has no treatment value. In the past it was referred to as a “sugar pill” but in the present it consists of an inactive substance. The placebo is used to assess if the experimental medication or treatment actually works. The positive thoughts of receiving treatment can make some individuals symptoms go away. However, these positive effects do not last long. This is called the “placebo effect”. However, over time this effect wears off and those subjects receiving actual treatment should continue to do better. When the statisticians look at the final numbers for all study participants and if placebo works as good as the study treatment then the treatment is not effective. Subjects receiving actual treatment must do significantly better that the placebo subjects for the drug to be approved.
A double-blind trial is designed so that neither the participant nor the staff knows which participant is receiving study medication and which participant is receiving placebo.
In a double-blind trial there is a period in which both the participant and the investigator do not know whether the participant is receiving placebo or study drug. Randomization occurs when the patient is randomly assigned to a specific treatment group. Randomization is used in trials to equally distribute people between the different treatment groups and/or placebo.
A single-blind study is designed so that one party, either the participant or investigator, is unaware whether the participant is receiving study medication or placebo.
An open-label trial is designed so that both the participant and the investigator are aware which treatment each participant is being administered.
There are four different phases in clinical trials. Each phase is designed to answer different questions. A phase one trial is the initial introduction of an investigational medication administered to healthy participants. Phase one trials are used to determine the medication’s safety in humans, side effects related to increasing doses, and its metabolism and pharmacological actions. Phase two is a controlled clinical study of an investigational medication to obtain common side effects, risks associated with the medication, and the efficacy of the drug for the indication being studied. Phase three trials consist of expanded controlled and uncontrolled studies conducted after obtaining initial evidence that implies the effectiveness of the drug at an optimally selected dose. A phase three trial aims at collecting additional safety information that will help in evaluating the overall benefit/risk relationship of the medication. Phase four trials are conducted once the drug has been FDA approved. A phase four trial is used to obtain long term information regarding the safety and efficacy of the drug.
Potential subjects must meet inclusion/exclusion criteria before they can begin participating in a trial. Each protocol has different entry criteria. This process begins during the initial telephone screening and is confirmed at the screening office visit.
Study participants should consider all available treatment options before agreeing to participate in a trial. The research team will discuss treatment alternatives before letting you participate in the trial.
Prior to starting any trial procedures the study coordinator will review the informed consent form with you. This document will list the risks and benefits of participating in the trial as well as your and the physician’s responsibility. You, the study coordinator, and the physician must sign this document before you may proceed in participating in the trial.
If the study drug is not working and your symptoms are worsening we will immediately withdraw you from the trial. In some cases it may take awhile for the drug to work and we may be required by the protocol to not increase the dose until a certain time interval. If that is the case then you and the psychiatrist must determine if you should continue with the trial. However, you may exit the trial at any time.
You will be seen by a psychiatrist at every study visit that your symptoms are evaluated. Some trials may require blood test or other testing where you will present to the clinic briefly but not need to see the physician.
Some of the protocols may require a prior diagnosis of the condition being studied. However, many trials do not. Our staff has been specially trained to evaluate your symptoms to determine if you meet DSM-IV criteria for that condition. They will also evaluate for other possible conditions.
The business hours for Sarkis Clinical Trials is 9 AM to 6 PM Monday through Friday. If you are interested in a study and are a good candidate for the trial the staff can bring you earlier or later in the day.
It depends on the study protocol. Some studies will allow for you to continue your current treatment. Other trials may require you to taper (decrease and discontinue) your medications before starting the study drug. The research team will explain all available options for your care.
At the conclusion of the trial you become responsible for the continuation of your treatment. However, our staff will be involved in the transition of your care from the trial even before the study ends. If the study drug is already on the market we will assist with completion of patient assistance program documents if you cannot afford the medication. We can also help with initial drug prescription so that you may receive treatment while transitioning back to your primary care physician or other provider. If the study drug is not on the market then we can assist with available treatment for your condition including patient assistance if necessary. The same is true if you participated in a strictly placebo controlled trial.