How a New Drug Goes from the Research Lab to Your Medicine Cabinet
From Bench to Bedside
Ever wonder how a new drug makes it to market? It's actually a long and complicated process that can take up to 15 years and cost millions of dollars.
Clinical research must go through a number of stages before a drug or treatment can be made available to the public—
- Preclinical research: Researchers conduct lots of experiments on new chemical compounds to determine which compound is the most effective and safe for use in humans.
- Investigational New Drug (IND): Scientists apply to the FDA for approvalto test the new drug in humans
- Clinical trials: Groups of human volunteers are tested to determine whether there are any adverse side effects from the drug and whether it works (phase I) and the ideal dosage (phase II). Then, they look at what happens when you give the drug to a large group of patients (phase III) to determine whether there are different responses or adverse effects with different types of patients.
The story of every drug that goes through this process is different. The fact is, most drugs don't make it beyond clinical trials. Those that do not make it, move on to the New Drug Application (NDA) step, in which the FDA considers approving the drug for marketing in the U.S. If and when it's approved, the drug can be made available to the public.
In many cases, researchers look at a drug once it comes to the market and compare it to other drugs that do the same thing. If and when they find a new indication for the drug, they go back to the drawing board and go through the testing process for the new indication.
Some of the most popular drugs in use today started out as treatments for one condition and turned out to be effective treatments for another condition. Take Viagra, for example. Originally tested as a heart medicine, it proved ineffective for that condition. Yet, when study participants reported an unexpected side effect (men who where impotent were able to have errections), new studies were conducted and the rest is history!
Did you know many of the most important and popular results from medical research actually were unplanned? Here are just a few:
- Botox - Surgeons noticed the softening of frown lines following treatment for eye-muscle disorders. Additional research has proven that Botox can also provide headache relief!
- Ritalin - Originally a treatment for adult depression, its potential for treating ADHD was discovered by accident!
- Retrovir - First studied as an anti-cancer drug, researchers later found that it could treat AIDS!
- Cardiac pacemaker - Discovered during research on hypohermia by an electrical engineer!
- Penicillin - The bacteria-killing fungus discovered because a scientist didn't clean up after his experiments!