Clinical trials are research studies that test new medications, new uses for existing medications, or new formulations or ways of taking existing medications (controlled release or inhaled instead of a pill) in humans. The purpose of clinical trials is to assess efficacy, safety and tolerability of potentially new treatments.
The Food and Drug Administration (FDA) regulates conduct of all clinical trials in the USA. FDA requires companies to show that new medications are both safe and effective before approving them.
Research Volunteers – an integral part of new treatment development.
Patients who take part in clinical trials have an opportunity to contribute to the progress, knowledge, and future treatment of medical conditions.
People volunteer to participate in clinical trials for many different reasons. Choosing to participate in research is an important personal decision. We will provide you with comprehensive information and straightforward answers to your questions regarding the risks and benefits of participating.
REASONS FOR PARTICIPATING
- Satisfaction of contributing to science and society
- Access to promising new medication not otherwise available
- Possible improvement in your medical condition
- Medical evaluations, lab tests, procedures, and study medication at no cost
- Quality care – including more face-to-face time with the psychiatrist and a more thorough evaluation than at usual medical visits.
- Some financial compensation for time and travel if you qualify for a study
- Confidentiality – no one including insurance companies can be informed of your participation in a clinical trial without your specific request and permission.
The Experimental Subject’s Bill of Rights is reviewed with participants prior to the informed consent. For every clinical trial there is a formal document that is called an Informed Consent Form (ICF) which provides information about the study, potential risks and benefits of participation, and outlines procedures that will occur during the study. Some ICFs may include a clause or separate form to authorize the disclosure of your medical information to the study sponsor and those involve in conducting the study.
This document, along with other information provided by the research team staff, should provide you with all the information you will need to make an informed decision about your participation. We will review and explain the ICF with you in a private and quiet environment, ample time to read the form and ask questions, and we will answer all of your questions to your satisfaction. You will always receive a copy of the ICF signed by you and at least one of the research team staff.
Since we will continue to provide any new information about the study medication or the study to participants while they are in the study, informed consent is really the process of learning the important facts and continuing to choose to participate. There is never any pressure to begin or continue participation. The ICF is not a contract, and participants may withdraw from the trial at any time for any reason.
THE CLINICAL TRIAL EXPERIENCE
Clinical trials vary, but they should always begin with a potential participant being given the Experimental Subject’s Bill of Rights and an Informed Consent Form. A potential subject’s eligibility is then assessed. If the person is eligible to participate and voluntarily chooses to do so, the subject will be given the experimental treatment or medication. In most studies, the subjects are randomly assigned (by a computer under no control by Excell Research staff) to either active medication or placebo (inactive sugar pill). The subject is then monitored over the course of the study which can vary from a few weeks up to over a year. During the study information is collected about possible changes in symptoms and any adverse events (side effects) that may occur. Frequency of visits varies by study, but is usually weekly or every other week. It is extremely important that subjects be able to come for their visits when required. The amount of time required at each visit also varies, but the initial visit is frequently several hours and subsequent visits are from 30-60 minutes. The procedures which occur at each visit can vary from being asked a few questions to a full set of physical and mental tests. Typically the first and last visits of a study will require more procedures than other visits. Following completion of a study, subjects may chose to utilize the follow-up care provided by our physicians. The psychiatrists will work with the subjects to try to find a treatment for their condition that they will be able to continue after the follow-up care which is usually for 2 months following the study.
A potential participant must meet specific eligibility criteria before being entered into a clinical trial. Determination of eligibility usually involves a physical examination, laboratory testing, and other diagnostic tests. A urine or blood test for drugs of abuse will be done, and a positive test will usually make you ineligible to participate in research. Your medical and psychiatric history, including current medications, must be reviewed, and you may be asked to provide your consent for previous doctors to release your medical records to us for review. Although each clinical trial has its own very specific criteria, in general, participants must be over 18 years of age with so significant unstable medical conditions and no current alcohol or drug abuse or dependence.
Your safety is our top priority; however, there are potential risks in taking any medication, even ones that are already FDA approved. The risk with experimental medication is considered higher because the actual effects on humans are not fully known and, indeed, that is some of the most important information that is collected during clinical trials. Although your health is monitored closely throughout a study, you may experience unpleasant or even serious side effects to the treatment.
Every clinical trial is monitored by the FDA and by an organization called an Institutional Review Board (IRB) that ensures that patients’ rights and welfare are protected. Before a study is approved by the FDA and an IRB, the pharmaceutical company must demonstrate that the study is ethical, that potential benefits of doing the study outweigh the potential risks, and that the study has been designed to minimize risk to patients. Additionally, all ethical and legal codes that govern regular medical practice also apply to research. In California there is also an Experimental Subjects Bill of Rights which must be reviewed and signed by participants prior to providing informed consent to participate in a clinical trial.
The personal information and healthcare data collected as part of a study will be encoded by your initials and a study number. However, we do keep a separate medical record in your name in the office that may contain more detailed information. 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 by the participant. We follow all California and federal regulations and guidelines for protecting your health information. Only at your request will we contact your personal physician to provide information.
People should know as much as possible about the clinical trial in which they are going to participate, and we encourage questions. The following are typical questions we have been asked. The answers to many of these will be provided in the ICF or in the research team staff’s review of the study with you; however, we are always happy to provide more information when it is available. We believe quality research occurs when well-trained professionals work with well-informed study participants.