A clinical trial is medical research to study the safety and effectiveness of an investigational drug or device. The US Food and Drug Administration (FDA) uses information gathered in clinical trials to evaluate medications before approving them for use in the United States.
Our professional staff consists of physicians, registered nurses, and clinical research professionals.
Before you are evaluated as a research participant, we will provide you with an approved Informed Consent Form (ICF) which you must read, understand, and sign before enrolling. The ICF outlines all procedures you will need to go through and all known risks and side effects of the investigational medication. Please read it carefully and ask all questions you might have.
Additionally, both FDA (www.fda.gov) and National Institute of Health (www.ClinicalTrials.gov ) maintain databases of clinical trials conducted in the US. All trials conducted by BCT are registered with FDA. If you need help finding information about a trial that you’d like to learn about, please do not hesitate to ask our staff.
In most studies, participants receive monetary compensation for participation in the study. The amount of compensation is set by the study Sponsor (the company conducting the research on the investigational drug or device) and is approved by Institutional Review Boards (IRBs). The exact amount you will receive per visit will be shown in the Informed Consent Form. Additionally, in some studies you may be offered transportation to and from appointments, meals, and childcare at the time of your visits.
Before conducting a clinical trial, pharmaceutical companies must obtain approval from the FDA to ensure that the investigational medication is appropriate to give to people.
Additionally, all study procedures are reviewed by an independent Investigational Review Board (IRB) before they are allowed to be administered. All this is done to ensure that the study is ethical and that the risks are as low as possible. However, since the study participants are among the first to try the investigational medication, the risk of unanticipated side effects does exist. This is why the health of the people participating in the trials is continuously monitored and any serious side effects experienced by any of the people in the trial are promptly investigated. If necessary, corrective actions, including termination of the trial, are taken.
Different studies have different enrollment requirements. Some studies are open only to healthy adults, other look for people with specific medical conditions, for instance, anxiety, depression, migraines, sexual dysfunction, etc. To determine whether you can enroll, we will ask several questions about your current health, your medical condition, and the medications you are taking. If you meet the study requirements, an appointment will be schedule for you to be evaluated in person.
Below is the typical process for a clinical trial:
- Screening interview – Information will be taken concerning your age, medical history, medications, and other preliminary questions to make sure you meet the study requirements.
- Informed consent – You will receive materials that fully explain the nature of the study and how you will participate. Our research staff will tell you of any known risks or potential side effects. It is very important that you ask questions and read the consent form carefully. Please ask any questions you might have to fully understand the risks and benefits of your participation.
- Assessments and medication – Once you are enrolled in a study, you may have a study-related physical exam, receive the study medications, undergo laboratory tests, and other study procedures. During the course of the study, research team members will meet with you regularly to monitor your progress.
Of course. Your participation in a research study is entirely voluntary, and you may withdraw from participation at anytime and for any reason. During your screening visit and throughout the study, we will fully explain the risks and benefits of your study. If you change your mind, you may withdraw.
You can register to be part of our volunteer database here and we will get in touch with you if you may qualify for a study.
Never. Any information you provide as a research participant is strictly confidential. It will not be sold and will be used only for the purposes of contacting you for relevant research studies.
Prior to Enrollment:
- You have a right to be fully informed about potential benefits and risks of the trial.
- You have a right to be fully informed about the trial plan, i.e., number and duration of the visits, study procedures, etc.
- You have a right to voice any concerns and ask any questions you might have about any aspect of the trial.
- You have a right to withdraw from the trial any time.
- You have a right to be treated with respect and attention.
- You have a right for compensation as indicated in the ICF.