According to the International Federation of Pharmaceutical Manufacturers and Associations, the global pharmaceutical industry is trending upwards. They have revealed that they project the global pharmaceutical industry to reach a value of $1.43 trillion by the year of 2020. As a result, there is no doubt that the phase 3 drug trial will rise in importance as well because these companies must make sure their drugs are safe for consumption.
The United States patent term for new drugs is 20 years, and patented drugs are eligible for five years of market exclusivity, which depends on the time between patent approval and the United States Food and Drug Administration approval. This type of stat is exactly why phase 3 drug trial is required because this is a tricky industry where the products must be safe. Here are the facts on the value of a phase 3 drug trial!
A 2018 MIT research project examined 185,994 unique clinical trials involving 21,143 compounds, held between 2000 and 2015. MIT researcher Andrew Lo found a higher overall success rate than previous studies, with the overall chances of success at about 10%. What this means is that as time goes on, the phase 3 drug trial is more successful over time.
The clinical trial includes three unique processes. This includes the phase 1 clinical trial, the phase 2 clinical trial, and the phase 3 clinical trial. All of these phases are equally as important as the other because they help determine when a drug is safe to be released to the public.
The importance of a phase 3 drug trial can be put on display through oncology drugs. These types of drugs help to treat tumors which is dangerous to the lives of many Americans. These types of advancements are important but they all start with phase 1 drug trials and phase 1 clinical trials.
According to a 2016 report from the International Trade Association, there are an estimated 100,000 over-the-counter drug products marketed and sold in United States stores. These stores must go through the phase 3 drug trial before they can be cleared but once they do, they can help treat previously incurable diseases! Thanks to the pharmaceutical industry, many deadly diseases have been cured. For instance, Hepatitis C once required life-long treatment and potentially a liver transplant. Today, 90-95% of patients can now be cured after receiving an 8 to 12-week drug treatment.
As of 2017, the research-based pharmaceutical industry spends $149.8 billion on research and development. As of 2014, five of the world’s leading 11 research and development firms were pharmaceutical companies. This information comes from The International Federation of Pharmaceutical Manufacturers and Associations.
There are typically four key phases in clinical trials. Phase one tests safety in human use; phase two tests the drug’s effectiveness at treating disease; phase three tests large-scale safety and effectiveness; finally, stage four tests long-term safety. Phase two clinical trials involve a larger group of people than phase one trials, and these studies can take up to two years.