Reason 1—Many Trials are Under-enrolled
Clinical research studies go on every day all around the world. But many studies or trials are under-enrolled and difficult to fill. A recent study conducted by the Tufts Center for the Study of Drug Development involving 150 clinical trials and nearly 16,000 study sites found that 11% of sites fail to enroll even one patient and 37% do not meet their enrollment goals.
Reason 2—All Ages are Needed
In the past, children and the elderly were underrepresented in trials, so there may be less data on how these age groups may respond to the drug or treatment being studied. How well and fast medications are absorbed, metabolized, and eliminated can vary among infants, children, teens, adults, and the elderly. Metabolism, body composition, liver and kidney function, and digestive function vary as we age. Therefore, some diseases that occur in both children and adults but that act differently—such as arthritis, heart disease, and diabetes—need to be studied for each group separately. Additionally, treatments and medications for illnesses and conditions that occur only or primarily among certain age groups also must be researched.
Reason 3—Both Sexes and All Genders are Needed
Both sex (male/female) and gender (identity/role/status/relationships) can affect health symptoms, risk factors, and outcomes. Males and females experience higher or lower risks of certain diseases, illnesses, or conditions based on their genetics and their environments; may react and report symptoms differently or seek medical care at different times based on their culture or societal norms; and may respond in various ways to medications or treatments based on a variety of factors from current health status to the rate of their metabolism. Additionally, in the past, research has been biased towards males, so some studies may be trying to make up for this fact by gathering female-only research.
Reason 4—Different Races and Ethnicities are Needed
Some diseases and conditions are characteristically of a specified race. Sometimes, the group to be treated for the disease includes a substantial number of patients in that population. There are a great number of genetic variations within racial or ethnic subpopulations, and substantial variation among the five major racial groups. Mendelian disorders, such as sickle-cell anemia and cystic fibrosis, are controlled by a single gene mutation that is inherited, and are almost always race specific. Additionally, like children, the elderly, and women, racial and ethnic minorities have been—and
continue to be—underrepresented in many studies. Important differences cannot be uncovered, identified, and intervened with in the groups in which they are needed.
Reason 5—People with Diagnosed Conditions are Needed
Trials are focused on a particular disease or condition, such as Alzheimer’s, Traumatic Brain Injury, ADHD, MS, or endometriosis. People who have been diagnosed with these conditions are needed for the trials. But people with other types of conditions are needed as well. As an example, people with heart conditions are needed. According to the American Heart Association, in 2015, 41.5% of the U.S. population had some form of
cardiovascular disease. Many of those are taking prescription medications, which can affect how the body processes other types of drugs. There is also a high correlation between heart conditions and other conditions which also may require medications, so those must be carefully managed. Even over-the-counter medications can interfere with these conditions and medications.
Reason 6—Healthy People are Needed Too
Sometimes trials will conduct genetic screenings for risk factors, and sometimes they will need people who are already at risk for specific diseases or conditions but do not yet have the disease or are not showing any symptoms. Some of these trials are testing ways to prevent the onset of the disease, so only those who do not have it can participate.
Reason 7—You Don’t Have to Pay Anything; In Fact, You May Get Paid to Participate
Volunteers rarely have to pay any costs to participate in a study. All of the costs of the medications or treatments, appointments, exams, etc. are usually covered by the sponsoring organization. Some trials will even pay you to participate! If there are costs not covered by the sponsors, these are usually routine care costs that would be done even if you were not in the trial, and, therefore, are likely covered by insurance.
Reason 8—There is Little Risk
Yes, there are risks associated with participation in a research study, such as side effects or ineffectiveness. But, laws require every clinical investigator to safeguard participants through strict rules regarding study plans or protocols and patient monitoring. The Institutional Review Board (IRB), made up of doctors, scientists, and citizens, must approve every single clinical trial in the United States and make sure that the risks are as low as possible. Additionally, many trials are closely supervised by a Data and Safety Monitoring Committee made up of experts who monitor studies as they are in progress. Plus, if you are taking part in a Phase III study, you are trying a new treatment that is not available anywhere else, and that has been tested several times already.
Reason 9—You Can Stop at Any Time
In addition to all of the safety standards described above, all clinics have a thorough informed consent process that will ensure you know exactly what the trial is about, what is expected of you, what your rights are, and will give you the chance to ask questions so that you are completely comfortable and confident in your decision to participate. If not, you can elect at any time to stop participating.
Reason 10—Volunteers Can Help Change the World and WE NEED YOU!
Per the National Institutes of Health (NIH), “groundbreaking scientific advances in the present and the past were possible only because of participation of volunteers, both healthy and those with an illness, in clinical research…As research opens new doors to finding ways to diagnose, prevent, treat, or cure disease and disability, clinical trial participation is essential to help us find the answers.”
Meridien Research conducts a wide variety of clinical research studies at our six Central Florida clinics and needs YOU! For more information or to see if you or someone you know may qualify to participate, please contact us today at 1-888-777-8839 or visit NewStudyInfo.com.