In the United States, the drug approval and licensing process is highly regulated, analyzing the current market as well as the benefits and risks of drugs which have exited the clinical trial phase. Using a number of different metrics and means of evaluation, the Food and Drug Administration (FDA) works to determine whether a treatment will provide advantages which outweigh its adverse effects, ensuring the safety of the intended population.
If you’re seeking a career in clinical research, the scope of your role will be closely tied to the drug approval and licensing process. When you complete your training at the NeuAge Institute, you’ll be equipped with the skills to carry out accurate, safe and effective clinical trials, leading to strong applications for licensing and approval. Below, discover more about the drug licensing process in the United States, and the importance of this process for clinical research professionals.
The Drug Moves Through Clinical Trial Phases
Before the approval and licensing processes can begin, a drug or treatment must undergo several different phases of clinical trials. During your clinical research training, you’ll become familiar with each clinical trial phase leading up to applying for approval. In Phase I, the drug will be tested by a small group of trial participants (typically volunteers in good health) in a study that centers around determining the drug’s safety and how well it’s accepted by the body. Phase II consists of a larger study with more participants, and is useful in determining an optimal therapeutic dose for the treatment. Phase III trials are both longer and more in-depth, determining the actual performance and effectiveness of the treatment. Here, trials may be randomized, in which one group is given a placebo and the other takes the actual treatment.
If all goes well throughout these phases, applications for regulatory approval may be submitted after Phase III, although some drugs will move on to Phase IV. In Phase IV, additional data about the side effects and potential dangers surrounding the treatment will be studied and discovered.
Analysis of Intended Treatment
After moving through the various clinical trial phases, the drug will then be ready to begin the licensing process. In the first stage, FDA reviewers conduct analysis on the current market for treatments of the condition targeted. They’ll see whether there are already significant treatments available for a certain illness, determine the overall need for the treatment and gain other information about the landscape. With this information, regulatory bodies will be able to make a more informed assessment about a drug’s benefits and risks.
Positive Outcomes and Risks Weighed
Next, the FDA will analyze the clinical data gathered. After completing a clinical research program, the quality of the data gathered during the clinical trial process will be crucial for success at this stage, determining the amount of uncertainties involved in approving the drug. The better-designed the trials are, the less potential biases or risks the FDA will need to weigh. Here, the FDA must determine whether the benefits the treatment yields for its patients will outnumber the adverse effects or risks.
While the benefits may outweigh the risks of a certain treatment, the FDA will still need a strategy to manage any associated risks in order to license the treatment and create an informative label. Thus, the next step is the development of risk management strategies, in which professionals will hold deliberations where the exact risks, and relevant protocol, are developed. Having a risk management plan in place helps the intended market to safely consume the treatment.
Prepare to Enter the Industry with a Clinical Research Program
At the NeuAge Institute, the courses you take will prepare you to design clinical trials and participate in the clinical research process in a way that facilitates success in the licensing process. In the course “Introduction to Drug Development Regulation, Principles of GCP,” you’ll learn about the timelines of approval for drugs in the United State, as well as relevant regulatory frameworks for the development of treatments. With the skills you build, you’ll be well equipped to enter the industry as a clinical research professional.
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