After psychotherapy became an established protocol for treating depression, interest turned to finding medications that would also help defeat the symptoms of this condition.

It takes quite some time — years in fact — to get a new drug on the market. From concept to market takes twelve to fifteen years, on average, and may cost up to $500 million. At any step along the way, the drug can be pulled and the project either modified or abandoned. It's a high-risk endeavor. Whether you believe pharmaceutical companies are agents for the public good or corporations primarily concerned with market share and profits, the world can't move along without them.

It Starts with an Idea

Scientists are always asking questions, and that's very important for the rest of us, who benefit from their insatiable curiosity. The questions they ask lead to breakthroughs in treatment of disease. Often, it's having witnessed a loved one struggle with an illness that becomes the motivation that fuels someone to pursue a lifetime of research. One researcher, obsessed with finding a cure for diabetes or cancer or depression, may spend an entire career in the pursuit of answers, hoping the payoff will come during her shift.

It's not random chance that leads to discoveries. Even before the research begins, however, a great amount of work has already been accomplished. Researchers have selected a medical condition and examined the biochemical processes involved in that condition. Next, they begin to develop drugs that will interact with those processes.

Compounding the Research

Plans for clinical trials begin in this earliest phase, along with the Investigational New Drug (IND) application that is sent on to the Federal Drug Administration (FDA). The IND lays out specific procedures that must be followed by the researching entity. It also specifies what the researchers can and cannot do. If the IND is approved by the FDA and by an Institutional Review Board (IRB), the manufacturer may begin the first phase of development.

Into the Lab

The lab and animal studies come next, and this phase reduces the number of drugs under consideration to about five. While it is uncomfortable to know that animals may die because of reactions to drugs that they receive, federal regulations do mandate that all animals used in laboratory testing be treated humanely. Using animals in drug research raises ethical and moral concerns for sure, and there are no easy answers.

Before humans are permitted to undergo drug trials, however, lab tests, which may include animal testing, are required. From here, the potential drug moves through three phases of testing that include humans.

Phase I Testing

Having successfully cleared the hurdles to this point, the drug now is tested on healthy individuals. The purpose of this is to discover the drug's basic properties and establish its safety profile. During this time, researchers will be examining the effects of one dose, increased dosage, and dosage that corresponds with a short-term course of treatment. Phase I will typically last from one to two years, and by the time it's complete, only one compound remains.

Phase II Testing

Now it's time for the target population to become involved. In Phase II, the drug is administered to volunteers of the target population to see how effective the drug is, or if it's effective at all. This is also the time for observing side effects of the drug. These trials are small scale, involving anywhere from 100 to 250 patients.

This is the nail-biter phase, because at the end of Phase II, the drug manufacturer meets with FDA officials to discuss the future of the drug in question. If the FDA is satisfied with progress to date, the plans for the final stage, Phase III are laid out. Phase III — Going for Broke

This is large-scale testing and is the most expensive part of the process. The paperwork submitted for each drug can reach over 50,000 pages.

While Phase III studies are in progress, preparations are made to submit the appropriate application forms to either the FDA or the Center for Drug Evaluation and Research (CDER).

This review can take from one to two years. Once the application has been approved, the manufacturer can put the drug on the market with FDA regulated labeling.