Clinical Trials Getting it Done
Clinical drug development. The word conjures to mind scientists in white lab coats and thick gloves going to work on pieces of equipment, possibly microscopes and vials full of gas, in order to create the next life-saving drug for the American population. These scientists are seen as men, though they can also be women. And they are here to save us,
America has a great deal of health problems. There is obesity and obesity-related illnesses which kill millions of people each year. There is cancer, which also kills millions, and heart disease, which kills millions. Generally in the top ten causes of deaths in the United States, a majority are preventable deaths.
We, as Americans, are struggling with our health.
Clinical drug development is important, in that it reduces symptoms or acts as cures for a number of conditions that ail Americans. There are new drugs in the pipeline every day for illnesses like cancer, diabetes, heart disease and more. Though some of these can be considered preventable illnesses, Americans feel they need pills to cope.
Developing a drug costs hundreds of millions of dollars. There is the designing of the drug itself, which can take years. But there are also all the clinical trials that a drug has to go through to be approved, and this process can take several years, sometimes a decade. The process of getting a drug approved is rigorous. There are four set trials.
Clinical trial one is the basic trial. The drug is tested on a small number of people to see if it harms them in any way. If it does, maybe to a significant amount, it is scrapped and years of work are lost. Then the drugs moves to the clinical testing phase two, where it is finally tested on more people.
Clinical test stages two and three for clinical drug development are two of the most difficult stages. Stages two and three involve the first of the placebo, double blind studies, in which the drug is tested on a number of people (called participants) and a number of the population is given a “placebo” which is a fake medication.
The drug has to show more positive effects than the placebo in treating the illness, something that is statistically significant. The drug is tested in more people in the third clinical trial than in the second. The pool becomes increasingly larger, with attempts to monitor side effects and efficacy of medication.
Clinical four is the largest trial in clinical drug development. It involves the most people, covers the most issues, including side effects, what populations it affects the most, and all things that will either make the drug successful in the trials or fail and be scrapped.
Most drugs in clinical drug development don’t get through this process and the company loses millions and millions, sometimes billions, of dollars. It is a gamble financially to have a drug in development, as so few get through the trials. But it is incredibly lucrative to the tune of billions of dollars if a drug gets through.
There are some statistics about clinical trials. They are:
- In Phase I trials, researchers test an experimental drug or treatment in a small group of people (20?80) for the first time. The purpose is to evaluate its safety and identify side effects.
- In Phase II trials, the experimental drug or treatment is administered to a larger group of people (100?300) to determine its effectiveness and to further evaluate its safety.
- In Phase III trials, the experimental drug or treatment is administered to large groups of people (1,000?3,000) to confirm its effectiveness, monitor side effects, compare it with standard or equivalent treatments, and collect information that will allow the experimental drug or treatment to be used safely.
There are some terms associated with this. They are phase I clinical trial, medical research studies, clinical study, phase I clinical trial Alabama, medical research studies Alabama, clinical study Alabama, clinical drug development Alabama, and more. There are many terms worth noting.
There are important things to note about being a participant in one of these trials. A person can sign up for one as part of a need for treatment. Because it is experiment treatment, it may prolong the life of the person, which is the case with possibly some cancer patients.