The Key Considerations Of Clinical Trials

By William McGinnis, Life Science Leader magazine

Clinical trials are only a small part of the research that goes into developing a new treatment. Drugs of the future, for example, first have to be discovered, purified, described, and tested in labs (in cell and animal studies) before ever reaching human clinical trials. About 1,000 potential drugs are tested before just one reaches the point of being tested in a clinical trial. On average, a new drug has at least six years of research behind it before it even makes it to clinical trials. But the major holdup in making new drugs available is the time it takes to complete clinical trials themselves. It takes an average of eight years from the time a drug enters clinical trials until it is approved.

Why so long? To be sure it is safe and effective, researchers look at each new treatment in several different studies. Only certain people are eligible to take part in each clinical trial. Clinical trials take years to complete, and it takes months, if not years, to see if a given therapy is effective. Thus, the rate of clinical trials participation determines how fast we advance the science.