WHAT IS A CLINICAL TRIAL?
WHY PARTICIPATE IN A CLINICAL TRIAL?
Many common treatments, such as brand name pain killers, would not exist without clinical trials. By participating in a clinical trial you may:
- Help others by contributing to medical research
- Gain access to new treatments
- Receive treatments at low or no cost
- Be compensated for your time and any inconvenience related to the study
PHASES OF CLINICAL TRIALS
Not all clinical trials are the same. There are multiple phases that a drug or device must go through before it is approved by the FDA. Procedures of clinical trials and size of the groups vary with each phase.
Pre-clinical: Bench work done in early development phase, typically on animals.
Phase I: Safety and Tolerability. The study drug is given to human patients for the first time. It is given at different doses. Side effects are analyzed at each dose in order to determine the safest and most tolerable dosing of the drug. Phase 1 trial groups are small.
Phase II: Efficacy. Safest doses of the drugs have been determined. The effectiveness of the drugs is determined in a larger group than what was tested in phase I trials.
Phase III: Comparison. The study drug is compared to currently FDA approved drugs. There are often multiple arms to this type of study. There is the possibility of either getting the study drug or getting the normal standard of care therapy.
Phase IV: After the drug is already on the market to study long term data. Phase IV are not always performed, but they can be FDA mandated.
ARE YOU ELIGIBLE FOR A CLINICAL TRIAL?
This depends on the question being asked. Some clinical trials look for people with certain diseases, and others need healthy people.
Participation in a clinical trial is based on criteria such as age, gender, certain medical conditions and treatment history, or your daily behaviors (for example, if you smoke). These are used to identify the highest safety standards while addressing the specific research questions.
BENEFITS AND RISKS OF CLINICAL TRIALS
WHAT SHOULD YOU THINK ABOUT BEFORE PARTICIPATING IN A CLINICAL TRIAL?
Learn as much as possible about the study and feel free to ask questions such as:
- What is the purpose of the study?
- Who is going to be in the study? How many will participate?
- Why do researchers believe the experimental treatment being tested may be effective?
- What kinds of tests and experimental treatments are involved?
- What are the possible risks, side effects, and benefits of the study treatment?
- How might this study affect my daily life?
- How long will the study last? How long will I be involved?
- Will I have to stay in the hospital?
- Who will pay for the experimental treatment?
- Will I be reimbursed for other expenses?
- What kinds of follow-up care will I have to do as a part of this study?
- Will I receive a copy of my own test results?
- Will my family physician know about my participation in the study?
- Will results of the study be provided to me?