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Before deciding to participate in a clinical research study, it’s important you understand the research study and clinical research in general. This way you can make an informed decision. Below are some common questions and answers about clinical research studies. Also, you may find it helpful to speak with your doctor before making a decision to participate.
A clinical research study is a research project done to find out if medications and treatments under development are both safe and effective. Each study is unique and conducted for different reasons. A clinical research study uses human volunteers. Participants are under strict supervision of a doctor and/or health professionals throughout the study. During the study, or trial, a patient may receive a study medication or placebo (not containing the active medication). As the trial goes on, more and more information is gathered about the treatment or device under investigation.
You may have heard of clinical trials and the “phases” associated with them. There are 5 phases, which are defined by the FDA (U.S. Food and Drug Administration). Three phases are most commonly known.
- Phase I studies are done during the earliest part of researching a treatment. These trials are usually small and include healthy volunteers to find out the safety of the drug.
- Phase II studies gather information to find out if the drug will have an impact on a certain condition. These studies typically use larger groups of volunteers and compare the drug in different ways.
- Phase III studies look further into safety and effectiveness of the drugs. These studies also use larger groups of volunteers and compare the drug in different ways.
The decision to participate in a clinical trial is a personal one. People volunteer for different reasons. Some want access to the most recent treatments under development. Some want access to specialists associated with a study. Others want to help advance science.
Either way, by participating you many help develop future medical treatments. Whatever the reason for your interest, be sure to do your own research ahead of time and make an informed choice about participating.
While not all do, many trials are able to provide payment to cover costs related to your time and travel. This varies by study and location. The study site will be able to provide payment information before you decide to participate.
Before you can participate, the research site will need to review information with you to check if you are eligible. All information you share is kept confidential.
Generally speaking, the study doctors and researchers will:
- Check your health at the beginning of the research study
- Give you specific instructions for participating
- Monitor you carefully during the study
- Stay in touch after the study is completed
In order to help you decide if you should participate, the study doctor and researchers will first explain the research study. They will then ask you to review an “informed consent document.” This document describes the clinical research study, including the study: purpose, length, procedures, possible known risks and benefits of participating, and what is expected of you if you take part. After you understand all the key facts about the clinical research study, you decide whether or not to sign the document and join the study.
Clinical research studies are regulated, following rules set by the FDA or other health authorities. The research study will follow a protocol. This is a detailed study plan that explains what the researchers will do in the study.
Each research study must also be approved by an institutional review board (IRB) or ethics committee (EC). IRBs and ECs are groups of people who help protect the rights and welfare of people in research studies. IRBs or ECs are usually made up of doctors, scientists, religious representatives and other medical and nonmedical people.
Your privacy will also be protected. The research team can’t tell anyone you’re participating in a research study without your permission. All of the information collected during the study will be kept confidential. Your name won’t be listed in any reports based on the study.
Different research studies have different risks. Some study medications can have side effects, some of which may be unknown. In some studies, some people receive the active study medication, while others receive a placebo. A placebo looks like the study medication, but it has no active components. However, whether you receive the placebo or active study medication, you’ll receive the same level of study-related care.
Your study doctor or research team should review all risks with you before you sign the informed consent document.
Yes, you have the right to leave a research study at any time. When you want to leave, tell the doctor or research team and explain your reasons for leaving.
After a clinical research study is finished, all of the information is collected and analyzed. The information will help determine the medication/device’s safety, effectiveness and side effects. In the U.S., final approval is given by the FDA. Outside of the U.S., similar organizations provide approval.
It’s important to talk to your doctor about a post-study treatment plan.