The Long Pharmaceutical Path to the Shelf

 

Pharmaceuticals are an extremely important part of our medical world. Without the use of pharmaceuticals, we would be unable to control a wide group of symptoms or to cure various diseases. Pharmaceuticals are constantly being improved, revised, and advanced. There are still many medications to be found. However, once a potential new medication is considered, it must go through a long process to reach consumers. Sometimes, these pharmaceuticals are offered to patients on a clinical study basis. Taking part in clinical trials can be beneficial for both the consumer and the pharmaceutical company.

The importance of informed consent

There are risks involved with anything that has not been thoroughly tested and retested. Even if there are minimal risks involved, the consumer needs to be aware of these risks. Informed consent means that they completely understand the intent and risks of the medications. Informed consent is so important that in the 9th revision of the American Psychological Association?s Ethical Code, it has its own section, 8.02. Before a consumer can begin the trial, they must be informed of all information regarding the process, and they must sign that they completely understand all of the terms.

Different risks associated with different phases

Each clinical study goes through different phases. The medical research studies Alabama begin at a phase 1 clinic trial. This part of the clinical study carries the highest risk, but the rewards may be the highest. However, the researchers will only test this pharmaceutical on a very small number of people during this phase. The group is usually only between 20 and 80 people, as the intent is to evaluate its safety and to identify any side effects. A person suffering from a disease or disorder should not participate in the phase 1 of the clinical drug development.

The next two phases

The next two phases are less selective and often product better of results, as changes have been made to the pharmaceutical. Phase 3, the drug is administered to 1,300 to 3,000 people to confirm its effectiveness, to monitor side effects, compare it with standard or equivalent treatments, and to collect information that will allow the experimental drug or treatment to be used safely. At this point, the drug has usually exhibited some type of benefit and has produced minimal side effects. Patients looking for an experimental drug for treatment may find it beneficial to join at this point.

Path to the market

Even with successful completion of the different phases, a pharmaceutical may never make it successfully to market. Even if the medication shows effectiveness, it could take many years to be approved. For this reason, experimental drugs for some are a great option. It is possible that there are no other medications on the market, expect for those that are currently somewhere in the clinical study phases. Some pharmaceuticals may also be delayed by patents and time limits on other medications. When a new medication makes it to market, it is given a specified number of years to market, before another one is also added.

The importance of clinical trials

Without clinical trials, new medications could never be developed. A clinical study is necessary to protect the majority of the market. The requirement of the clinical trials also prevents dangerous medications from flooding the pharmaceutical industry. Clinical trials are an essential part of the medication research and advancement process. Additionally, the people that take part in the clinical studies are crucial and always needed.

Much of the world relies on pharmaceuticals. We also rely on the constant research and improvement of new medications. In order to continually improve and develop new medications, clinical studies are needed. These clinical studies go through a variety of phases, each with important requirements. Taking part in a clinical study is not only beneficial to the greater good, but can also be advantageous to reducing symptoms.