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Clinical research studies are research studies involving human subjects that serve to test drugs or devices under development. It is through clinical trials that doctors, drug and device companies, and regulatory agencies like the FDA are able to bring new and better treatments to market. Clinical trials are necessary to determine the effectiveness and safety of medications under development, first by testing the drugs in normal healthy people and later extending testing to people with medical illness. Clinical trials are required by the FDA before any manufacturer can market a prescription product. As you can imagine, thousands of these trials are conducted each year in the US and abroad.
There are many steps involved in bringing a new drug from the chemist’s bench to the patient’s bedside. Once a new drug candidate is identified in a laboratory, it is usually tested in laboratory animals so that scientists can understand the basic properties of the drug. This is called “pre-clinical” testing, and thousands of new drug candidates will be examined in order to produce one candidate that is worthy of going forward into clinical trials. Clinical testing is the most expensive aspect of drug development. According to some industry reports, the pharmaceutical industry spent $44.5 Billion on research and development in 2007 with clinical development costs representing approximately 60% of these expenditures! Many people speculate about the high cost of new drug products, but it is important to realize that for every 250 new candidates tested, only one – yes, one – will become a marketed product. By current estimates, it costs about $1.2 Billion to bring just one drug to market. So the manufacturer has to cover the cost of all of the research and development it does with that one approved medicine.
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