How a Clinical Trial Works
The process of getting a drug on the market is an extensive process. Before clinical trials, the new treatment has to have laboratory findings (first in cells then animals) and then it has to be approved by the Health Ethics Committee. If the study is approved it will go into three phases of clinical trials:
Phase I (20 - 80 patients) Tests for safety using healthy individuals, and can lasts about two years.
Phase II (100 - 300 patients) Tests safety, dosing, and efficacy. This is administered to a target population.
Phase III (1,000 - 3,000 patients) Tests safety, efficacy, and side effects.
Typically there are multiple trials for each drug. In the 1980s a drug had an average of 30 clinical trials and involved about 1500 patients. By the 1990s these numbers more than doubled to an average of 60 trials per drug and involving nearly 5,000 patients.
After the phase III the drug manufacturer files a New Drug Application (NDA) and the FDA reviews the trials case. This process takes about two years.
Types of Trials
Diagnostic Trials: Used to find better testing procedures for a diagnosing disease.
Prevention Trials: Finds ways to prevent disease in healthy individuals or prevent the disease from returning. This includes vaccines, medicines, vitamins, minerals, or changes in lifestyle.
Quality of Life Trials: Look for ways to help improve the quality and comfort of life inpeople with chronic illnesses.
Screening Trials: Test the most effective way for detecting a certain disease.
Treatment Trials: Test experimental treatments, new approaches to surgery or radiation, or new drug combination therapies.
That’s all great, but why should I care?
Every drug that is on the market has to go through these procedures. It is a process that averages about nine years from start to finish. A lot of people don’t have that kind of time to wait for drugs to enter the market. It is also important because if a drug therapy isn’t ethical and somehow passes FDA regulations, then it is you the consumer that suffers the consequences.
It is sometimes easy to think that drugs that have not been approved by the FDA are better. Individuals who may participate in an experimental drug therapy need to be aware that there are a lot of risks, such as: (1) Suffering from adverse long-term or short-term side effects that could possibly be life-threatening, (2) the drug therapy may not be effective, (3) patient may be taking the placebo and not be receiving any medication, (4) it may require a lot more time and energy than it would to be taking a drug that is already on the market. Before going into a study make sure that you have enough information going into it.
References:
Photo: 2007- CNN Money
Daniel B. Klein, Alexander Tabarrok 2009 fdareview.org
U.S. National Institutes of Health 2007 clinicaltrials.gov
It does seem lengthy and I'm sure it IS costly. That is reflected in the extremely high cost of medication. It is too bad that the rest of the world doesn't have to obsorb some of these cost along with Americans. Mexico and Canada don't seem to have to pay as much as we do in the good old USA!
I was looking for an artical I had read that relates to this subject of high cost of medication and how the drug companies use this to their advantage in some cases. It is a look at how Prilosec was altered to become Nexium. The company knew that their money making drug would be going generic and they didn't want to loose their cash cow, so they took out one of the ingredience and resubmitted it to the FDA. Since Prilosec was already approved they didn't have to start from scratch with the whole drug study program. They just had to prove that Nexium was more effective. The study showed that Nexium was a slight improvement with 90% over Prilosec with 87%. Nexium was approved and is one of the nations top selling drug.The drugs are virtually the same.
This is what is wrong with the high cost of medications. To see the article go "The New Yorker" Archives of 2004.
Sue, you have an excellent point. I recommend that you check out our links on the side bar to one of our classmates pharmacology blog. It deals specifically with the high cost of prescription drugs.