Clinical researchers need volunteers so they can conduct studies to learn more about important new drugs; drugs that can lead to cures for diseases like cancer, high blood pressure and Alzheimer’s. When you volunteer to participate in a drug trial, you contribute to the development of medical therapies that can ultimately help thousands of people.
There are many reasons people get involved in the clinical trials. Giving your time and energy to aid scientific progress is just one. Sometimes people who have a disease for which no treatments have been found sign up for studies with the hope that they can help researchers discover a way to stop that disease. Others, especially those without medical insurance, volunteer to receive intense personal medical care through the clinical trial.
Whatever your reason for wanting to participate, you should always ask the staff of your research center any questions you have before you agree to volunteer. It is extremely important that you go into a study completely aware of all that it requires of you.
What Is A Clinical Drug Trial?
A Clinical trial is an important research study that has been designed to test treatments that are currently under investigation. People who volunteer receive these treatments, which have been developed by pharmaceutical and biotechnology companies. Volunteers in the trial are always under the supervision of a doctor, nurses, and other research professionals. These researchers have been chosen by the drug companies to investigate treatments because of their professional qualifications and experience in conducting trials.
Every clinical trial conducted goes through a review by the federal government’s Food and Drug Administration (FDA) and various Institutional Review Boards (IRBs). IRBs are independent committees formed to ensure that volunteers’ rights are protected and that they are not exposed to any unnecessary risks. Before you participate in a trial, you will be required to sign an IRB-approved consent form.
There are four phases of clinical trials. Only a few people participate in the first phase, but the last three phases involve large numbers of people.
When you volunteer for a trial, you are placed in a specific study group. Some members of this group receive the drug being investigated, while others are given a placebo, an inactive product that has no effect. By comparing volunteers who took the study drug with those who took the placebo, researchers learn more about the new drug’s effects.
Usually it is not known even to the doctor and nurses who is receiving the study drug and who is taking the placebo until after the end of the trial. This allows the physician and research staff to observe all volunteers impartially. So whether you are given the investigational drug or the placebo, you are receiving the same concentrated level of medical care.
Testing a treatment under investigation is a carefully-monitored process that provides you with state-of-the-art medical care. If this were not the case, clinical trials would not have become as successful as they are today.
What Is My Role In The Study?
When you agree to participate in the drug trial, you will be given a detailed explanation of the procedure involved in your specific study. What is expected of you will be outlined in your consent form.
Many study participants appreciate the detailed medical attention they receive throughout the trial. In most cases you will have a thorough physical examination and your medical history will be reviewed by the study physician or a member of the research staff. But your medical records will remain private and confidential. The trial data that is provided to the pharmaceutical company and the FDA will not include your name, or the names of other people involved in the study.
Your personal safety during a drug trial is the number one concern of researchers. It is important for you to show up for all your scheduled visits to the research clinic and to take your medication at the time prescribed. The investigator or doctor needs to record any symptoms you feel, no matter how minor they may seem to you. Therefore, you are expected to answer all of the investigator’s questions about how you feel and whether you have taken your medicine at the prescribed time.
Feel free to talk to research staff or study doctors about your medical history, treatment or condition at any time during the study. Healthcare professionals who conduct clinical trials are dedicated to providing you with quality medical attention: they want to hear what you have to say.
What Happens After The Study?
Once the study is complete, all the data collected is organized and analyzed to determine whether the drug under investigation is working, whether it is safe, and if it has any significant side effects. This information is carefully reviewed by FDA medical advisors and specialists before any new drug can be approved.
After a drug has been approved, pharmaceutical companies continue to conduct studies, Phase IV studies, that compare its safety, cost and effectiveness to other drugs already on the market. Some studies assess how the drug can be properly administered to children, or to people with special health conditions. Other trials determine the drug’s long-term effectiveness and its impact on the quality of a person’s life.
Your Help Is Needed
As a volunteer, you are the most valuable person involved in a clinical trial. Without help from people like you, no new drugs would be discovered to help fight diseases and other health problems. When you agree to participate in a drug trial. You help yourself and others live longer and healthier lives.
