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The Main Phases of Clinical Research: Going From Preclinical to Phase IV

Feb 23, 2021

Over the last few months, people all over the world watched as various COVID-19 vaccinations completed the different phases of clinical research, nearing ever-closer to approval. 

 

Technically, there are four phases of clinical research but each subsequent vaccination announced its success and approval after Phase III. 

 

So, what are the phases and what does that mean for the drug development process?



Preclinical Research

Before the phases of clinical research begin, there is an important preclinical process. This step is to gather information on the efficacy and toxicity of the drug and the ingredients used. These tests can be conducted on laboratory animals, human cells, and human tissues. 

 

Preclinical research is necessary to prove the drug is safe enough to begin testing on human volunteers. 



Phase I

The first phase of clinical research begins on a small group of volunteers, usually less than 100. Volunteers for Phase I are generally healthy volunteers, although there are situations (like cancer) where the volunteers will need to have the disease/condition. 

 

The purpose of this step is mainly to test if the drug is safe for human consumption. In a process called “dose-ranging”, different amounts of doses will be used to test which amounts are most safe and/or most successful on the subjects. 

 

Phase II

Moving up to a few hundred volunteers, Phase II studies the drug on those with the disease or condition for which the drug is being developed. Using the therapeutic dose decided on in Phase I, these tests are to show the efficacy and any side effects of the drug. 



Phase II is technically not to show whether the drug will be beneficial or not, but to prepare researchers for Phase III and its larger pool of volunteers, providing data to develop new protocols and research methods for future studies. 


Phase III

The largest study before approval, Phase III involves up to a few thousand participants. This study shows the efficacy of a drug, the benefits it can provide, and any side effects from long-term exposure that might have gone undetected in earlier phases. Depending on the drug being tested, this phase will either focus on a specific population or require a more diverse pool of volunteers for drugs meant to be used in a more general population. 


With the completion of Phase III, the developer can then combine all information collected during the multiple studies and submit an application to the relevant regulatory authority for approval. Only after approval will a drug undergo Phase IV.


Phase IV

After approval, a drug is released on the market but continues to be monitored. This is called Phase IV or Post-Market Safety Monitoring. 


The main purpose of this phase is to monitor the long-term effects of the drug for continuing approval or possible removal from the market. Additional reasons for this phase are to find new purposes for the drug and to test the drug on populations deemed too sensitive for earlier phases (for example, pregnant women are rarely included in Phases I-III). 



CfPIE: Your Answer to Understanding the Drug Development Process

Are you looking to learn more about the different phases involved in drug development? Our course, “The Drug Development Process: From Concept to Market,” will benefit any who needs an understanding of the drug development process, from those in R&D to marketing and sales personnel. This course will prepare you to understand every part of the process, from beginning to end. 


Have questions? Get in touch with a member of the CfPIE team by calling 1-610-648-7550 or emailing [email protected].


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