Clinical Research and Participation
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
- US Centers for Disease Control and Prevention
https://blogs.cdc.gov/nchs-data-visualization/deaths-in-the-us/ - American Cancer Society https://www.cancer.org/latest-news/facts-figures-report-cancer-deaths-avoided-in-2-decades.html December 31, 2014. Accessed January 2015.
- US Centers for Disease Control and Prevention, National Center for
Health Statistics. Health, United
States, 2013: with special feature on prescription drugs. Hyattsville, Md. http://www.cdc.gov/nchs/data/hus/hus13.pdf. 2014. Accessed February
2015. - US Food and Drug Administration. FDA approves Orbactiv to treat skin
infections. FDA Press release. http://www.idsociety.org/FDA_20140807/. Published August 6, 2014.
Accessed February 2015. - US Food and Drug Administration. FDA approves
Sivextro to treat skin infections. FDA press release. http://www.pharmatimes.com/news/fda_approves_cubists_sivextro_to_treat_skin_infections_1002087?rl=1&rlurl=/14-08-07/FDA_clears_third_antibacterial_for_skin_infections_this_year.aspx.
Published June 20, 2014. Accessed February 2015.
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:
Research for a new drug begins in the laboratory.
Drugs undergo laboratory and animal testing to answer basic questions about safety.
Drugs are tested on people to make sure they are safe and effective.
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.
Safety Monitoring
FDA monitors all drug and device safety once products are available for use by the public.
small group of people (2-80) for the first time to evaluate its safety, determine a safe
dosage range, and identify side effects.
larger group of people (100-300) to see if it is effective and to further evaluate its
safety.
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.
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.
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.
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!