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Conducting Clinical Trials For A Step Closer to FDA Approval

Once the Research and Development stage of the drug development process is completed, it’s time to see if the efforts that were put into coming up with a potential solution to a disease will be an actual viable cure. After going through multiple cycles of research and development, the new drug must be tested to ensure that it is not only safe, but also to determine whether or not its utility is maximized. Before putting their drug to the test, however, the test itself must be created. This is done through a preliminary stage we call the preclinical trial stage, where the researchers figure out what exactly should be tested. Afterwards, the preclinical trial is followed by the clinical trial stage, which is where the real work starts.

During the preclinical trial stage, researchers consider what questions relating to the medical product need to be answered. Testing a drug in human subjects is not something that can be approved easily, so all possible questions and follow-ups must be thought about well before starting the actual clinical trials. Before a drug can be tested on people, the drug company performs laboratory tests and may perform trials on animals to get a deeper understanding of how the drug works on an living organism, and how humans will react to the drug.

Then, the researchers must make a long list of decisions. This includes how long the study will last, the dosage and intake method of the drug, and various other determinants that may be important to ensuring that the drug will not create any issues and can be approved by the FDA (Food and Drug Administration). The researchers should also determine what kind of assessments should be tested to best ensure the safety of the product. In addition, it is important that they read into the FDA’s drug approval process, and create studies that will ensure meeting the FDA’s standards and help answer any questions that may arise while the FDA is inspecting the new product.

One of the most crucial aspects of designing a clinical trial is getting the right participants. The researchers must determine how many people will be part of the trials, and who qualify to participate. Depending on the drug being tested, the clinical trials may call for participants who are healthy, or on the other hand, people who have specific illnesses and conditions. Eligibility to participate can also depend on demographics such as age and gender, and can be as specific as what stage of a disease the potential participant is at, and what their previous treatment history is. The more specific the criteria is, the more difficult it can be to find people who are eligible and willing to be part of the clinical trial. In order to reduce the stress of finding participants for studies, a resource that pharmaceuticals can use is HealthLink Connect Solutions, which aid in recruiting physicians and candidates that have the specific requirements that a clinical trial might ask for.

When the clinical trials and tests are over, it’s time for the company to send the product and all of their research material to the FDA. Even with all of the time and money that went into the research, trials and draft production of the potential new drug, the company will have to go back to the drawing board if the FDA rejects it. In order to let the FDA know about their product, the pharmaceutical company submits a New Drug Application, which must include the drug’s test results, manufacturing information to show that the company can properly produce the drug, and the data gathered during the animal studies and human clinical trials. Last but not least, the company must also include a proposed label for the drug, including the uses for what the medicine has shown to be effective for, possible risks of the medicine, and how the medicine should be used.

In order to have the best chance of getting a drug approved by the FDA, it’s important to know how the approval process works. The FDA’s drug approval process has its own structured process:
● Analysis of the target condition and available treatments
● Assessment of benefits and risks from clinical data
● Strategies for managing risks

Knowing beforehand what exactly the FDA looks for and making sure to include detailed reports with full explanations for each of these points can greatly increase the chances of a new drug being approved.

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