Clinical Research and Participation
Clinical Research and Participation
What is clinical research
You are vital to medical advancement

If you have any doubt about the impact of clinical research, think about this: in 1900, the average life expectancy for an American was about 47 years, but with new and improved drugs coming to market that help people live healthier lives, the average life expectancy is now 78 years!!! Medical advancements made possible by research have played a major role in:

  • Lowering the cancer death rate by almost 22% since 1991 2,3
  • Reducing the HIV/AIDS death rate by nearly 85% 4
  • Offering hepatitis C patients cure rates near 90%, with few side effects, in as little as 8 weeks2,3

Every day, significant breakthroughs happen in the world of clinical research – and a critical part of that is due to study participants. People just like you.

Sources

Dear Medical Research Heroes,

Thank you for participating in our clinical trials and advancing medicines for a better tomorrow.

How drugs make it to market

Before a new drug or treatment is available to the public, it must first go through clinical studies to ensure that it is both safe and effective. This process takes time and, more importantly, relies on people like you to help. Around the world, people are living healthier and longer lives because of strangers who volunteer for clinical studies.

Read more about the drug development steps below:

Step 1
Discovery and Development
Research for a new drug begins in the laboratory.
Step 2
Preclinical Research
Drugs undergo laboratory and animal testing to answer basic questions about safety.
Step 3
Clinical Research
Drugs are tested on people to make sure they are safe and effective.
Step 4
FDA Review
FDA review teams thoroughly examine all of the submitted data related to the drug or device and make a decision to approve or not to approve it.
Step 5
FDA Post-Market Safety Monitoring
FDA monitors all drug and device safety once products are available for use by the public.
What are clinical study phases?
Clinical studies of experimental drugs proceed through four phases:
In Phase I clinical studies, researchers test a new drug or treatment in a small group of people (2-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase II clinical studies, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase III studies, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase IV studies are done after the drug or treatment has been marketed. These studies continue testing the study drug or treatment to collect information about their effect in various populations and any side effects associated with long-term use.
Who can participate in a clinical study?

Some research studies seek participants with illnesses or specific conditions, while others need healthy volunteers. All clinical studies have guidelines regarding who can participate. Requirements are based on factors such as age, medical history, medications being taken and ability to attend all visits. Before you join a clinical study, you must qualify for the study by meeting these requirements. These requirements are called inclusion and exclusion criteria and are defined in the study protocol and informed consent process. It is important to note that these criteria are not mean to reject people personally, but are used to identify appropriate participants and ensure safety. The criteria also help ensure that researchers are able to understand the data gathered in the study and answer questions about the drug or medical condition.

Your role in clinical research

Clinical studies are a required step in bringing new and improved breakthroughs in medicine from the researcher to the patient. These studies evaluate the effectiveness of an experimental drug or treatment and how it effects people’s health and wellbeing. They ultimately allow the U.S. Food and Drug Administration to determine if the medicine is safe and effective, and should be made available to the public either through prescription or over the counter. These breakthroughs in medicine wouldn’t happen without the participation of volunteers like you!

Actual study participant
Lenexa, KS
“Enjoyed my stay and the staff are wonderful.”
Actual study participant
Lenexa, KS
“All employees were extremely courteous and helpful.”
Actual study participant
Lenexa, KS
“Wonderful staff. I am a newbie, but friendly and helpful staff eased the apprehensions.”
Actual study participant
Lenexa, KS
“PRA has an excellent staff from recruiters to medical staff, and a nice, clean facility.”
Actual study participant
Lenexa, KS
“It looks to me like PRA staff is courteous and very knowledgeable of the proceedings and well-being of every participant.”
Actual study participant
Lenexa, KS
“The staff at PRA is wonderful. Very professional and friendly.”
Actual study participant
Lenexa, KS
“Staff is friendly and professional.”
Meet some of our extraordinary people and discover what PRA means to them!
About PRA Health Sciences
We’re committed to the drug development process because we understand how it impacts the lives of patients and their families. At the end of the day, we’re not just researchers. We’re patients. We’re survivors. We’re family members.
We use cookies to give you the best online experience. If you disable the cookies, you may not be able to access some parts of the site, it may also not work as intended. You can find out more about how to manage and delete cookies by visiting www.allaboutcookies.org. Please also see our Privacy Policy.