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What is Clinical Research?



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 pharmaceutical companies 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 the first 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.

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 clinical trial begins with Phase 1 and ends with Phase 4, each phase serving a unique and important purpose.

Phase

Timeline

# of Volunteers

Purpose

1

1 - 4 Weeks

10 - 100

Drug safety

2

Months

100 - 400

Drug safety and efficacy

3

Years

1000+

Drug success and side effects

4

Years - Decades

Millions

Observance of continued success


Phase 1

This phase requires a small group of volunteers, typically less than 100, and takes place over a course of 1-4 weeks. The objective of this phase is to test the safety of the study drug.

Phase 2

Next, the drug is tested for both safety and effectiveness on a slightly larger group, about 100-400 volunteers, over the course of several months. About 33% of study drugs advance past this phase of the research process.

Phase 3

This phase is aimed to measure the success of the drug as well as observe side effects over the course of years, usually requiring over 1000 volunteers. Only 25% of drugs move on to Phase 4.

Phase 4

The final phase of a clinical trial takes place after the drug is on the market. This phase extends over the course of years, sometimes decades, in the form of continued monitoring of side effects and drug success. The goal of Phase 4 is to determine the long-term safety of the treatment, as well as to observe effects in a less controlled setting.

Now That We Know the 'What', Let's Cover the 'Who'.

Clinical trials are run by 3 main organizations, called sponsors. These sponsors are:

  1. Pharmaceutical companies

  2. Federal agencies

  3. Free-Standing Sites


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 10 studies at once, such as ClinOhio Research Services.

Each site has clinical research coordinators, or CRCs, that give medical attention and care to study participants. Typically, the CRCs have several open lines of communication with study participants to ensure their comfort and safety throughout the trial.

While many clinical sites have slightly different staff structures, you will find the following at the majority of sites:

  • Clinical Research Coordinator: Often nurses or qualified medical professionals who interact with patients, perform tasks according to study protocols and file all patient information

  • Principle or Clinical Investigator: Typically physicians or specialists who oversee and monitor the patients for all improvements or adverse side effects

  • Clinical Trial Monitor: Representatives from the study sponsor who oversee all patient files and ensure documentation is correct and organized

  • Pharmacovigilance Associate: Individuals responsible for researching, assessing, understanding and ultimately preventing dangerous side effects in medications and vaccines

Altogether, clinical trials are a critical part of public health. Without medical research, widespread medicine availability and ever-growing treatment options simply would not be possible.

If you are seeking alternative treatment options, please visit our currently enrolling studies page or call (614) 583-6800 to find a study that is right for you.



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