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What is Clinical Research?

Woman wearing lab coat and masks holds test tubes, completing the clinical research process.

Clinical Research: What is it and Who is Involved?

It’s mid-March, 2021. You’re sitting in front of your TV, watching the same news program that brought you live updates on the ever-growing number of patients infected with the COVID-19 virus. However, today is different. Today, you hear a report that scientists have begun Phase 1 of an experimental trial for a COVID-19 vaccine.  

You’re thinking, This is great! Maybe we can get back to the life we knew before our new normal became buying outfit-matching masks and being afraid to sneeze in public.  

Then, the words “Phase 1“, “Experimental” and “Trial” squeeze the warm idea of returning to business as usual from your thoughts. Sure, you’ve heard the term ‘Clinical Trial’ before. But what does it really mean?  

While the majority of us have only recently become familiar with clinical research terms because of the coronavirus pandemic, the origin of clinical trials dates all the way back to 1747 when Naval Officer James Lind performed a controlled study on scurvy-afflicted sailors.  

Since then, the field of medical research has become an oasis of knowledge, saturated with the ideas of biologists, physicians, pharmaceutical companies and tech agencies. So, let’s get down to it.

What is a Clinical Trial?

According to the World Health Organization (WHO),

“Clinical trials are a type of research that studies new tests and treatments, and evaluates their effects on human health outcomes.”

Clinical trials are made up of volunteers who are, in the majority of cases, compensated for their time, travel and participation within the study. Trials can include people of all ages, sometimes even children, and often need thousands of volunteers throughout the study process. 

What Does ‘Phase 1’ Mean?

Every medication and treatment goes through a four-phase trial process, each phase serving a unique and equally important purpose.

PhaseNumber of VolunteersAmount of TimePurpose
110-1001-4 WeeksDrug Safety
2100-400Several MonthsDrug Safety & Effectiveness
31000Multiple YearsObserve Drug Success & Side Effects
4MillionsYears-DecadesObserve Continued Success and Possible Side Effects after Drug is on the Market
Phases of a Clinical Trial

Now That We Know the “What”, Let’s Briefly Cover the “Who”

Clinical trials are run by large organizations called sponsors. A sponsor can be one of three types of organization:

  • Pharmaceutical Company
  • Federal Agency
  • Individual

The sponsor determines the location or locations of the study, depending on the scope of work. These locations are called sites.  

Sites can be large, factory-seeming locations that run hundreds of studies at a time, or they can be smaller power-houses that run 15 studies at once, such as ClinOhio Research Services.  

Within each site, there can be a myriad of different professions, some of the most common being:

  • Clinical Research Associate (CRA)
  • Clinical Research Coordinator
  • Clinical Research Nurse
  • Director of Clinical Operations
  • Principle Investigator
  • Clinical Trial Monitor
  • Biostatistician

Clinical Research: The Silent Healer

While the details of clinical research are not often known, it is important to spread awareness of drug trials. Without the willingness of people worldwide to volunteer in research studies, modern medicine would not be accessible to the public.

If you are interested in learning more about clinical research, or would like to enroll in a study, visit our currently enrolling clinical trials page or give us a call at (614) 683-5800.

Sources

National Institute of Health

National Center for Biotechnology Information

World Health Organization

FDA

Now Enrolling: Lupus Erythematosus Study

Lupus Erythematosus New Clinical Trial Study

If you currently have Cutaneous Lupus Erythematosus and have had the disease for at least 3 months, and if you have active cutaneous lupus erythematosus skin lesions that are evaluated to be moderate to severe, there’s a new study that you may be interested in.

Study Requirements:

  • Diagnosed with Cutaneous Lupus Erythematosus
  • Have had the disease for at least 3 months
  • Have active skin lesions that are moderate or severe

Call Karen at 614-683-5800 for details.

Now Enrolling: Uterine Fibroid/Endometriosis Study

We are seeking women ages 18 to 50 with uterine fibroids or endometriosis to participate in a clinical study evaluating an investigational oral contraceptive (birth control). Additional study eligibility criteria apply. Participants will receive study-related care and the study drug at no cost.

The time commitment for this study is 10 visits over an approximately 2-year period.

Requirements for participation:

  • Be female of child-bearing potential between 18 & 50 years of age.
  • Have a diagnosis of uterine fibroids or endometriosis.
  • Be sexually active at least once per month.

Additional study criteria may apply.

Compensation may be available for time and travel.

Now Enrolling: Cytomeglavirus Vaccine Trial

Cytomeglovirus Vaccine Clinical Trial Study

ClinOhio Research is looking for participants for a vaccine study to help prevent Cytomegalovirus (CMV) infections in women. Overall, 10% to 15% of infants born to women with CMV infection during pregnancy are symptomatic at birth. Of these symptomatic infants, 4% to 12% die in their first year of life and 70% to 80% survive to potentially suffer lifelong disabilities.

If you are a woman between the ages of 16-19, or a woman between the ages of 20-40 and work with children age 5 or younger, or have children 5 or younger, you may qualify to participate and will be compensated for your time spent participating in the study.

Contact us today for more information or to see if you qualify.