Clinical trials are an important part of getting drugs and medical devices FDA approved. Without clinical trials we wouldn’t know the safety and effectiveness of these medicines. Many people are not aware of clinical trials and how they can volunteer. Click here to learn about our currently enrolling and upcoming research studies. You can also click here to search with CenterWatch for clinical trials for a certain medical condition. Before participating in a clinical trial it is important to understand what is involved.
There are benefits and risks with every clinical trial. Benefits include:
- The opportunity for patients to play an active role in their own health care
- Gain access to new research treatments before they are widely available
- Help others by contributing to medical research
Risks may include:
- Unpleasant, serious or even life-threatening side effects to treatment
- Treatment that is not effective for the patient
- Studies that are more involved and time intensive than an approved treatment
There are four main types of clinical trials:
Phase 1 – the first step in a series of drug studies to test a potential drug with a small group of volunteers to determine potential side effects
Phase 2 – involves a larger group of volunteers to learn more about side effects and how the body uses the drug
Phase 3 – tests the new drug with one for the same or similar condition
Phase 4 – these studies often take place after a drug has been approved to study long-term effects and compare the drug to others on the market to determine cost-effectiveness
Here are a list of questions that you should know the answers to before participating in a study. Most of these questions should be answered in the consent form you sign before study procedures begin, but you can ask a study coordinator or doctor any other questions.
- What is the purpose of the study?
- What is required of me?
- What is my role in the study (healthy vs. patient volunteer)?
- Will I potentially
- How long will the study last?
- Will I be reimbursed for time and travel?
- receive placebo or an already approved treatment?
- Will the study directly benefit me?
- Will the study benefit others?
- Are there risks? If so, what are they and what are the chances that they will occur?
- What discomforts are involved?
- What is the total time involved?
- Are there other inconveniences?
You can find more information about clinical trials by clicking one of the links below.
NIH – Are Clinical Trials For You?
FDA – Clinical Trials and Human Subject Protection
