A research study is conducted in people to evaluate an investigational drug, or medical device. The purpose of research studies is to determine whether a treatment is safe, tolerable and may be effective treating different diseases in the future.
A clinical investigator is a medical researcher conducting a research study. Researchers are usually doctors, nurses, pharmacists, or other medical professionals.
Research studies are typically conducted by a trained medical professional. An Institutional Review Board (IRB) or Ethics Committee (EC) reviews all research studies. This is a committee made up of doctors, ethicists, administrators, and members of the general public. This group helps to ensure that the rights of research participants are protected. Your regular doctor is responsible for your well-being and you may want to speak with your doctor before agreeing to participate in a study as there are risks associated with taking any drug. Whenever you agree to enter a study, you are given the name and telephone number of a contact in your research study physician's office who will answer your questions. You will also be provided contact information for the IRB or EC should you have questions or concerns.
There are many reasons people take part in research studies. It gives individuals a chance to receive investigational study drugs or medical devices not available to the public.
Often, the process of collecting information in the study will allow the study doctor to find out more about the disease and its effects.
Lastly, a study may not benefit participants directly, but the information gathered may be of help to other individuals with the same condition in the future. Many study participants derive satisfaction from knowing they may be a part of the effort to potentially reduce the suffering of other people in the future.
You can find out about research studies from many sources. There are often advertisements in your doctor's office. Many research studies are posted on Internet pages such as this one and can be an excellent source of information. Each study has specific requirements for participation. Your study doctor will take a medical history from you and may request additional testing to determine if you are eligible according to the criteria for the study.
Anyone agreeing to participate in a research study is required to sign an informed consent form. The informed consent form provides the details about the study and explains the potential risks. In addition, the informed consent form explains your rights and responsibilities. This document will tell you what study drug may be given, what kind of side effects might occur, and who to contact if you have questions or concerns.
Yes, a patient who lives at home, in an assisted living facility, or skilled nursing home may be eligible to participate in the study.
Talk with the study team (doctor and staff) at the study site. They may be able to help assist with transportation issues.
Yes. Participants can still continue regular visits with his or her doctor(s). You or the study team should notify his or her regular doctor of their participation in the research study.
Study participants may be able to stay on their current medication(s). The study team will discuss current medication(s) and potential participation in the study with each patient during the screening visit.
Research studies must follow strict ethical and legal standards. In addition, the global and country health authorities regulate clinical research with built-in safeguards to protect study participants.
Yes. Participants can withdraw from the study at any time. If you or your loved one wishes to withdraw from the study, you should notify the study team.