Clinical trials are research studies that evaluate efficacy, safety, and tolerability of new potential medications. All the steps of each clinical trial are clearly pre-defined. All our clinical trials are monitored by the Food and Drug Administration (FDA) and by an organization called an Institutional Review Board (IRB), which ensures that patients’ rights and welfare are protected.
For every clinical trial there is a formal document that provides information about the study and explains potential risks and benefits of participation, and outlines all study-related procedures. This document is called the Informed Consent Form (ICF). We will review and explain the ICF with you in a private and quiet environment, giving you ample time to read the form and understand its contents. The study physician will be available to answer all your questions, and only after all your questions have been answered to your satisfaction will the study physician sign the ICF. You will receive a copy of the ICF prior to undergoing any study procedures.
The personal information and healthcare data collected as part of a study will be encoded by your initials and a study number. We do keep a separate medical record under your name. This information will not be sent as part of the research data; however, the pharmaceutical company or the FDA may have access to this information if required. No information will be released to insurance companies, employers, schools or other physicians, unless requested in writing by the participant. We follow all Arizona and federal regulations and guidelines for protecting your health information.
All clinical trials have study-specific criteria about who can participate. These specific criteria are determined by the Pharmaceutical Companies that sponsor clinical trials. They set the rules for who may or may not participate in clinical trials. Most clinical trials require that those who participate are generally of good physical health and that they do not use street drugs or drink alcohol.
We receive research grants from pharmaceutical companies to conduct clinical trials. Therefore, it is the pharmaceutical companies who pay for treatment and office visits for study participants.
- To receive medical evaluations, laboratory tests and study related procedures at no cost
- To help in the development of new medical therapies. You and society may benefit from the information obtained from this research.
- To possibly have access to cutting-edge treatments before they are available to general population
- To have access to expert medical care during the trial
Since clinical trials usually provide only short-term treatments related to a specific illness or condition, and do not provide extended or complete primary health care, we encourage participants to continue their relationship with their primary health care provider and/or psychiatrist. At your request, our staff will keep your doctor informed.
You may leave the study at any time and for any reason, but we do appreciate being informed of your decision to leave the study and the reason you have decided to do so. Information about reasons why one discontinues participation in the study is important data for the pharmaceutical company.
It is made to look exactly like the active medication, but it contains no active ingredients and is not expected to provide benefit for your condition. In clinical trials the experimental treatments are often compared to placebo to assess the treatment’s effectiveness. Participants are randomly assigned (by a computer) to either active medication or placebo, and neither the participant nor the research staff know which the participant is receiving.
It is a study plan carefully designed to answer specific research questions and safeguard the health of the participants. It describes what types of people may participate, the schedule of tests and procedures, medications being used and their dosages, and the length of the study.
Because most medications we study are not yet FDA approved, at the end of the study, you will most likely not be able to continue on the study medication. However, we provide 2 months of complimentary psychiatric care and will work with you to find another appropriate treatment and will make appropriate referrals for future care.
During clinic hours if you have any questions or problems, contact our office and your research coordinator or psychiatrist will provide assistance. After clinic hours, our answering service will put you in contact with one of the psychiatrists who are available 24 hours a day, 7 days a week.
You will have the option for ongoing treatment. This treatment may include up to three months of after-study visits with our doctors. We will work with you to provide you appropriate referrals in the community if you desire so.
Our office is typically open 9:00 a.m. to 5:30 p.m. Monday through Friday. We may be able to accommodate slightly earlier or later appointment times.
This varies a lot depending on the clinical trial. The initial visit will be at least 2 hours because you must learn about the study, sign the informed consent, give a complete medical and psychiatric history , and have several procedures done. Other visits range from 30 minutes to several hours but are most commonly about 45 minutes.
This varies greatly between studies. Your participation will usually be over a period of 8-12 weeks, but could be as long as one year.
This information will be in your Informed Consent Form and will be provided to you at your initial visit. For studies lasting 8-12 weeks, the visits are usually every week or every other week. For longer studies, the initial visits may be weekly, but later in the study are usually monthly.
No. All study related medical procedures, laboratory tests, and study medications are provided at no cost to you.
You will be compensated for your travel and time, as outlined in the Informed Consent Form.
The specific risks and benefits for a particular study will be explained to you and provided in writing in the Informed Consent Form.