What is Clinical Research?
Clinical research involves testing an investigational drug or device in humans. Each clinical trial must use a protocol that has been written according to government regulations and that is also approved by the company sponsoring the study.
An investigational drug may be:
- A drug that is currently on the market but that is being studied for a non-approved indication or is being studied in a new route of administration, strength, or formulation.
Before an investigational drug or device can be studied in humans, its safety and effectiveness is carefully studied in the laboratory.
However, this early research cannot predict how safe and effective the drug will be in humans. With any new treatment there may be benefits as well as known and unknown risks.
Clinical research trials are conducted to determine whether promising new treatments will be safe and effective for patients.
WHAT SHOULD I KNOW BEFORE PARTICIPATING IN A RESEARCH STUDY?
You should know as much as possible about the research study before you participate. It is important that you feel very comfortable asking questions and that the staff answers them in a way you can understand. When preparing for a meeting with the study coordinator or doctor you should plan ahead and write down the questions you want to ask. Review the study website to help you prepare questions to ask. You might ask a friend or relative to come with you for support and to hear the responses to your questions.
WHAT HAPPENS DURING A STUDY?
The study procedures and process will vary depending on the type of clinical trial you participate in.
Before you begin a study, the process and all procedures for that study will be explained to you. Throughout the study, the Study Coordinator and the Principal Investigator will assist you and can answer any questions you have.
They will check your health at the beginning of the trial, give you specific instructions for participating in the trial, monitor you carefully during the trial, and stay in touch with you after the study.
All clinical trials have criteria that determine who is allowed to participate. You cannot participate in a study if you don’t meet all of the study criteria.
Some clinical trials involve more tests and doctor visits than you would normally have for your illness or condition. Your participation will be most successful if you carefully follow all instructions, you are given and stay in contact with the research staff.
¿WILL I GET PAID FOR PARTICIPATING IN A RESEARCH STUDY?
You will usually be paid for your time and travel while participating in a clinical study. Surgery, medical exams, and medical procedures may also be performed at no cost to you depending on the type of study. If a study requires you to stay at a research facility for any length of time, you may also receive meals or snacks.