Clinical tests of new medicines are a vitally important part of the drug development and approval process—they account for 45 to 75 percent of the $1.2 billion average cost of developing a new drug and are conducted to determine the safety and effectiveness of that treatment in patients.
Some trials are also conducted to compare existing treatments and some are done to learn if a drug is appropriate for a different patient population, such as children. Still others are conducted to find ways to make existing approved drugs more effective and easier to use with fewer side effects.
It’s essential that trials be conducted properly so that clinicians and drug reviewers can develop accurate assessments of the efficacy and safety of medicines when used by patients. The Food and Drug Administration (FDA) is a vigilant regulatory agency and its pharmaceutical review officers are effective in detecting flawed information.
Questionable or confusing data can lead to lengthy delays in product approval or outright FDA rejection of a new drug.
Biopharmaceutical research companies are looking for the best physicians and research institutions to meticulously help design and conduct their clinical trials to determine whether a medicine is safe and effective. Side effects must be painstakingly documented and a determination made as to whether they occur too often and are dangerous.
Clinical tests involve three phases and thousands of volunteer patients and are often conducted at multiple sites around the country. In Illinois, biopharmaceutical companies have the luxury of having trials conducted at the states’ well-respected university medical schools, comprehensive cancer centers and clinical trial research centers. According to U.S. News and World Report, University of Chicago’s Pritzker School of Medicine ranked 12th, Northwestern University’s Feinberg School of Medicine ranked 19th, the University of Illinois College of Medicine ranked 56th, Rush University College of Medicine ranked 70thand the Stritch School of Medicine at Loyola University ranked 71st among this year’s top 100 research-oriented medical schools in the United States.
“At a time when the state is focused on creating jobs and rebuilding the economy, clinical research and the biopharmaceutical industry have been real bright spots. These companies provide thousands of good-paying jobs, and to the extent they succeed in finding innovative medicines, they make the entire workforce stronger and more productive.” --David Miller, President and CEO iBIO (Illinois Biotechnology Industry Organization)