One major reason clinical trials exist is that scientists need to test the effectiveness of drugs they create in the lab. This process, called drug discovery, can be a long and expensive one, taking approximately 10 years and $2.6 billion. It will often involve pharmaceutical companies, researchers, doctors and patient volunteers.
Psychiatrist Andrew Cutler, MD, is one of the doctors at Meridien Research working with pharma to develop new treatments for his patients. Primarily, he tests drugs that modulate and regulate dopamine, a chemical in the brain that plays a role in ADHD, general anxiety disorder, bipolar disorder, depression and schizophrenia.
“These companies, on average, spend over a billion dollars to bring a drug to market,” Cutler said. “The drugs I research have to have some sort of benefit for my patients.”
Some patients unnecessarily worry that any drugs tested during clinical trials will be ineffective or dangerous. Pharmaceutical companies follow strict FDA guidelines to ensure no serious harm will come to trial volunteers. Also, because the investment required to bring a drug to market is so high, companies will not spend their time or money creating a drug that does not work.
All clinical research done must be approved by the FDA. Drug discoverers submit an Investigational New Drug application before beginning a clinical trial to outline data from animal studies and any possible toxicity, manufacturing information, plans for the clinical trial, data from any prior human research and information about the investigator. The FDA has 30 days to either approve, delay, or deny the application. Approvals often come with comments about how to make the trial better for patients or more effective.
There is no way to test the effectiveness of a new treatment other than through clinical trials, like those conducted at Meridien Research. Less than 12% of drugs tested in trials make it to market, but the drugs that fail help researchers hone in on other possible therapies through collaboration. This is Cutler’s favorite part of research.
“One of the things I also enjoy is working as part of a team. Research is a team sport, not an individual sport. And that’s fun.”
Please search by location on our website for more information about Meridien’s current clinical trials or call 888-77-STUDY today.