Why Joining A Clinical Trial Matters

Tests, treatments, and disease prevention need to be as safe and effective as possible for everyone who will use them.

Mistrust and other barriers to participation have kept many people, including those from communities experiencing differences in health conditions, from volunteering for research studies. Injustices and exclusions of people from these communities in past research have partly led to this distrust. However, it is very important to include people from every community and background in clinical trials and research. Diverse participation gives us better information about how drugs or vaccines will work for different people.

3 reasons we need clinical trial and research study volunteers of all ages,
races, ethnicities, genders, and physical abilities and with different
underlying health conditions:

1. Data from research studies and clinical trials play a critical role in how the
   U.S. Food and Drug Administration (FDA) decides whether drugs, devices, and
   vaccines are safe and effective for people to use. Without a wide range of people
   participating, it is hard to know if a drug or device will work differently for some
   people based on their background and experiences.
2. People respond differently to drugs and other treatments. A person’s age, race,
   ethnicity, sex, body weight, and overall health can affect how they respond to a drug
   or other treatment and could affect their risk of having a harmful reaction.
3. Where people live, work, and play and their overall health can put them at higher
   risk for some diseases and conditions. It is important for researchers to understand
   how a drug or treatment will affect the people most likely to need it.

You can play a role in making sure that the drugs and vaccines developed
to prevent and fight illnesses are as safe and effective as they can be for
as many people as possible.
 

How am I protected if I join a clinical trial or research study?

If you volunteer for a clinical trial, your rights and well-being are protected. Major changes have been made to how studies and clinical trials are run today. Every study must follow strict safety rules and have a thorough review before, during, and after it is conducted. Critical steps are now in place to make sure that all volunteers and their personal health information remain as safe and protected as possible. For example, all government-funded clinical trials in the United States are approved and watched at several different levels. This includes reviews by independent groups called institutional review boards, which are separate from the people conducting the research. You can read more about research participation and protection from the HHS Office of Human Research Protections.