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How Are New Medicines Developed? What Health Education Professionals Need to Know.
Modern medicine has revolutionized the world, allowing us to live longer, healthier lives. But developing new medicines isn’t easy. The drugs available in our hospitals and pharmacies took a long and difficult road to the shelves. In fact, for every 5,000 to 10,000 compounds that enter preclinical testing, just one ever reaches the marketplace.1
If you’re looking to start a career in health education so that you can help others live healthier lives, it can be helpful to understand the pharmaceutical development process. Here’s how it works in the United States.
The first step to developing new medicines is to find a chemical or biological agent that shows evidence of being able to treat a specific condition. To identify promising agents, clinical researchers use existing knowledge, laboratory tests, and computer modeling. But the process isn’t swift. It can take 3 to 4 years to identify an agent worth taking to the next phase.
Not all clinical researchers do animal testing, primarily due to ethical reasons. However, when clinical researchers identify a promising agent they believe can be used in humans, they often test the drug in animals, typically rodents. The purpose of the testing is to determine whether the drug is safe. If the drug proves toxic or causes chromosomal damage, the drug is abandoned. If it proves safe in animals, researchers proceed to the next step.
Application for IND Status
Before clinical trials in humans can begin, researchers must get approval from the U.S. Food and Drug Administration (FDA). To do this, researchers apply to have the drug classified as an investigational new drug (IND). If the FDA is satisfied with the quality of the research, the methods of manufacture, the rationale for human testing, and the planned testing strategy, they grant the approval.
Phase 1 Clinical Trials
With IND approval, researchers begin the first phase of human testing, which focuses on safety. Clinical researchers, supported by medical professionals, give 20–100 healthy adult volunteers low doses of the drug. About two-thirds of INDs prove safe enough to move on to the next phase.
Phase 2 Clinical Trials
Phase 2 clinical trials administer the drug to patients suffering from the condition the drug is intended to treat. These trials are kept small, with the number of volunteers just large enough to be statistically significant (usually 100–300 people). The purpose of phase 2 trials is to determine effective dosing, the best method of delivery (by mouth, intravenously, etc.), and how frequently patients need the drug for it to work optimally. Researchers also monitor safety. In a high number of cases, INDs fail to move beyond phase 2 because they’re found to be ineffective, unsafe, or too prone to produce intolerable side effects. The few INDs that do survive phase 2 move on to the final round of premarket testing.
Phase 3 Clinical Trials
Lasting anywhere from 2 to 10 years, phase 3 clinical trials involve thousands of patients located in multiple sites. This phase is designed to confirm effectiveness, demonstrate further safety, and determine the best dosage. Around 90% of INDs make it through phase 3 testing.
Once clinical researchers are satisfied that the drug is safe and effective, they submit all their findings to the FDA, seeking the approval to market and sell the drug. If the FDA approves the drug, they may require a post-market phase 4 study that examines risks in larger, more diverse, or high-risk populations. Even if the FDA doesn’t add stipulations, drug makers monitor every new product and are required to provide the FDA with quarterly reports about adverse reactions for 3 years following a drug’s release into the marketplace.
The Importance of Health Education and Promotion
Preventative care and education can save lives, much like research and new health initiatives can help make the world a healthier place. If you want to advance your career as a health educator, an online MS in Health Education and Promotion or PhD in Health Education and Promotion can help.
Best of all, earning your master’s or PhD in health education and promotion doesn’t require you to upend your life. With online education, you can complete your coursework at the time and place that are most convenient for you. You can even earn your degree while continuing to work full time.
Walden University’s MS in Health Education and Promotion and PhD in Health Education and Promotion can help you prepare to sit for the Certified Health Education Specialist (CHES) exam or the Master Certified Health Education Specialist (MCHES) exam.
Walden University is an accredited institution offering MS in Health Education and Promotion and PhD in Health Education and Promotion programs online. Expand your career options and earn your degree in a convenient, flexible format that fits your busy life.
Walden University is accredited by The Higher Learning Commission, www.hlcommission.org.
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