NeuAge Institute (NAI)

From Discovery to Development: Understanding the Drug Research Process in Clinical Research Training

Drug research is an important part of clinical research and a rigorous journey that demands significant time, energy, and resource investments. Aspiring clinical researchers or pharmacovigilance officers must know all about the best practices that go into it – from discovery to the development stage, to succeed in future related endeavors. This is why clinical research training programs like the one offered at the NeuAge Institute are so essential. In this blog, we explore the work that goes into the clinical research process.

How Our Clinical Research Training Program Benefits You

At NAI, we recognize that quality clinical research training can make a world of difference in the life of any pharmaceutical professional and pave the way for future advances in drug development. That’s why our training programs are designed to equip students with the hands-on training and professional development resources needed to excel in the pharmaceutical industry.

Our Drug Development, Clinical Research, Drug Safety, and Pharmacovigilance Diploma and Certification programs are taught by some of the industry’s best hands, and our teaching curriculum and practice facilities provide favorable learning outcomes. During the program, students will receive in-depth instruction on Good Clinical Practices (GCP), management, monitoring, and quality assurance concepts in clinical trials, pharmacovigilance regulations, and Good Pharmacovigilance Practice (GVP). Further, they are exposed to the stages involved in the drug research process, as discussed below: 

The Discovery Stage

This first stage – The Discovery Stage, leads scientists and researchers to identify new drug candidates (drugs in development). These “drug candidates” are identified from a series of tested biological/chemical compounds that are found to interact with the disease-causing genes/proteins, often called target molecules.

The Preclinical Research Stage

Next is The Preclinical Research Stage, which involves rigorous drug candidate testing to check if it can be safely and effectively applied to humans. Here, animals are used as test hosts to examine the drug’s toxicity, pharmacodynamics, and pharmacokinetics, and three key areas of concern in its interaction with the human body. Researchers request the go-ahead to conduct human-tested clinical studies once the tests have been reasonably confirmed to be successful.

clinical research professional working with high-tech equipment during the clinical research training
As taught in clinical research training, the preclinical research stage is the first stage of the drug research process

The Clinical Research Stage

The Clinical Research Stage follows next, a stage that is typically marked by a three-phase testing schedule (sometimes four). With each new phase, the number of tested people (those given the drug) increases, and the testing regimen/process becomes even more rigorous. As you’ll discover during clinical research training, the first “safety” phase involves testing on about 20-80 healthy volunteers to check if the drug’s outcomes are consistent with the results observed in the preclinical stage regarding its safety.
The second phase, the “Proof of Concept” phase, builds on the favorable safety results from the previous phase and proceeds to check for the drug candidate’s efficacy. In this stage, the drug candidate is applied to about 100-300 patients suffering from the disease for which the drug was developed. The minimum and maximum dosages to be used in the subsequent development phase are also determined.

male clinical research professional working in a laboratory during the clinical research training
The clinical research stage involves four phases, as you’ll learn in clinical research training

Next is phase three, the “regulatory evidence” phase, which follows from positive results relating to the safety and efficacy tests from previous stages. About 1000 people are tested with the drug candidate to provide final and documentable proof of the drug’s safety and clinical efficacy. The long testing period and the extensive test pool allow researchers to identify and address any side effects of the drug. 

Market Approval and Launch Stage

The final stage is the Market Approval and Launch stage. In this stage, all relevant findings from the discovery stage onwards are submitted to regulatory authorities such as the FDA for use in accessing and approving the drug. 

The drug’s chief investigators and promoters seek approval to market it to the public, basing their arguments on verifiable proof of its positive results from all three testing phases. Once the required approvals are granted, the drug can be formally launched in the market. 

However, regulatory agencies may require some type of Post-Marketing Surveillance (the fourth phase) to check if the medicine (formerly called drug candidate) is safe and effective in the general population. 

If this interests you, pharmacovigilance training may be the right choice!

Contact the NeuAge Institute to learn how you can get started.

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