English (United States)

What is a clinical study?

A clinical study is research involving people to understand human health and disease. A clinical trial is a type of clinical study. Clinical trials look at specific medical treatments to see if they are safe and effective and whether the benefits outweigh the risks. An investigational medicine must be studied in humans before it can be prescribed to people.

We need people to take part in these clinical trials to help develop new medicines.

Are clinical studies safe?

Researchers must follow very strict rules to ensure the safety and well-being of everyone taking part in a clinical study. Clinical studies are carefully monitored by various regulatory agencies, such as the:

  • Food and Drug Administration (FDA) in the United States
  • European Medicines Agency (EMA) in Europe
  • Ministries of Health or regulatory authorities in other countries around the world

These government agencies are responsible for the rules and regulations for the conduct of clinical studies.

  • Institutional Review Boards and Ethics Committees
    Institutional Review Boards (IRBs) and Ethics Committees (ECs) or other review bodies are responsible for reviewing proposed and ongoing clinical studies. IRBs/ECs make sure the rights and welfare of people taking part in clinical studies are protected. Members of IRBs/ECs include scientists, doctors, and other experts, as well as regular (non-medical) members of the community.

Why do people take part?

Some people take part in clinical studies to contribute to medical research and to help doctors find new ways to help patients. Others take part because they hope to receive an investigational medicine because their condition is not responding to standard treatment. However, there is no guarantee that an investigational medicine will work.

It's important that all kinds of people are represented in clincial studies. This is because certain conditions and medicines may affect people differently based on their:

Race
Ethnicity
Sex
Age
Background

The people taking part in a clinical study should represent the patients who will use the medical treatment.

Group of friends involved as participants in clinical trials and clinical studies

What is it like to take part?

First, you will be given information about the clinical study before deciding whether you want to take part. This is called the “informed consent process.” If you agree to take part, doctors will see if you meet the requirements of the study. This process is called “screening,” and may involve some medical tests and assessments, and a review of your medical history. Each clinical study has different requirements for screening.

In a randomized clinical trial, you will be assigned at random (meaning you cannot choose) to receive a study medicine. The study medicine could be either the investigational medicine, a standard medicine, or a placebo. A placebo looks the same as the investigational medicine but contains no actual medicine. Using a placebo in clinical studies is done to see if there is a difference in health connected to the investigational medicine.