What is a Study
Clinical trials are scientific studies that test the effectiveness of a new medical treatment or device with patients. While many years are spent on laboratory and animal research to determine the general use and safety of a new treatment, a clinical trial evaluates the effectiveness of the medication in people with specific medical conditions. A clinical trial may show that the investigational treatment is better than, as good as, or no better than the standard treatment for the same condition.
The human or "clinical testing" of a new medication is one of the most critical stages of drug development. It is carefully regulated by the FDA (Food and Drug Administration). The FDA requires pharmaceutical companies to supply detailed information about the doctors (investigators) and staff selected by the sponsoring company to conduct clinical studies. This information is reviewed by the FDA to ensure that investigators meet the FDA standards for conducting clinical studies.
Participation in a clinical trial is a partnership and a commitment between the research team and volunteer patients. It is the final test in a series of many carefully controlled scientific studies that are done to improve the quality of life of people with medical conditions such as yours.
Why do a study?
Questions Answered in the Informed Consent
When you agree to participate in a study, you will be asked to sign an Informed Consent Form.
The Informed Consent Form provides information about the medication being studied and the specific procedures to be followed during the study. It describes the anticipated effects of the test medication, including current knowledge of its safety and effectiveness. It also includes issues of confidentiality, a statement of treatment alternatives, and a California Subject's Bill of Rights. This document assures the FDA that you’ve been informed of your rights and are aware of the risks and benefits of participating in the study, and that your participation in the study is voluntary.
What happens if you become involved in a clinical study of a new medication?
On your screening visit, you'll meet the research team member who will review your medical history and current condition. Based on your screening results, you may or may not qualify to be enrolled in the study. If you do qualify, the investigator or staff member will describe the study and explain the Informed Consent Form. If you do not qualify for the current study, you may be screened for other current or future studies.
You will generally undergo a physical examination and appropriate tests. Tests might involve taking blood and urine samples and if you have asthma, checking your lung function. If you qualify, you will then receive your first supply of study medication, thorough directions on how to take it, and any special procedures which must be followed. Depending on the study design, you may receive the study medication, a placebo* or a medication that is already on the market for treatment for the same condition. You will generally be required to keep track of your symptoms and medication use at home in a study diary.
On follow-up visits, you'll talk to the clinical investigator or staff member about what has happened since your last visit. This includes assessment of any change in your symptoms and any new symptoms or possible side effects. General quality of life may be assessed through specific questions. Your medication schedule will be reviewed and you will be given more study medication.
*You may participate in a study comparing placebo (a harmless, inactive compound) to the study drug. Placebo can be an effective therapy for certain patients. Therefore, the study drug must prove more effective than placebo to be considered effective.
Your important responsibilities during a study
As a study volunteer, you'll be expected to comply with the study requirements. This means you will need to take all supplied medication as prescribed, and keep all your scheduled appointments. Other medication should only be taken as medically necessary and should be reported to the study center. If there is any question, please check with the research center prior to taking any new, non-urgent medications.
Proper compliance by you assures that the information collected about the medication will be accurate and reliable. Missing your medication for a day or more may affect your health and the results of the study. Missing a scheduled visit may cause difficulty in proper, timely testing and medication administration which could further defeat the purpose of the study. Therefore, if you need to miss a scheduled visit, please notify our office ahead of time to reschedule another visit.
Take your medication when and how it is prescribed, and keep all study appointments. Be honest with the staff if you have not taken your medicine and inform them if you feel ill or have new symptoms or concerns.
What are your safeguards as a clinical study patient?
As a patient under a doctor's supervision, you are protected by the same laws and ethics that normally regulate the medical profession. Informed consent helps protect you by making sure you have been giving all the necessary information about a study. The FDA requires an institutional review board (IRB) to review the general progress of the study.
The IRB consists of members of the community of both medical and non-medical backgrounds. It is their role to review and evaluate clinical research from the patient's point of view to ensure that the risks of involvement in the study are reasonable and that you are provided with enough information to make an informed decision as to whether to participate. Your choice to participate with the understanding of what the risks and potential benefits of the study are is called "informed consent".