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.
|Phase||Number of Volunteers||Amount of Time||Purpose|
|1||10-100||1-4 Weeks||Drug Safety|
|2||100-400||Several Months||Drug Safety & Effectiveness|
|3||1000||Multiple Years||Observe Drug Success & Side Effects|
|4||Millions||Years-Decades||Observe Continued Success and Possible Side Effects after Drug is on the Market|
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
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
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.