Kenya Society of Physiotherapists Clinical study,Clinical trials,Phase 1 clinical trial The Process of Drugs and Treatments in Clinical Trials

The Process of Drugs and Treatments in Clinical Trials

Clinical drug development

There have been countless developments over time in regards to science, medicine, and things that help the human body in some way or another. But these developments can often take time, in order to be studied, applied, certified, and finally marketed and distributed. And things run a little bit differently today than they did in past eras, where one apparent positive outcome is then labeled as a success for all and distributed as such. In fact there were times in which highly addictive and harmful substances such as cocaine, heroin, tobacco, and even chloroform were used as medicine prescribed and recommended by doctors.

Obviously the system needed to be improved upon in order to ensure the health and safety of the general public. Medical research studies are more in depth and comprehensive than ever before. Today, new medicines, treatments, and dietary aides must be run through a series of tests and clinical trials before they become a product available for widespread consumption.

How clinical trials can help understand a new treatment

Clinical drug development involves the clinical study of the drug or treatment in different groups of people. There are a few different steps, or phases, that need to be taken when conducting these clinical trials, and they will often last for several weeks or months, but it most often takes years from the discovery or invention of the new treatment to the day that it becomes fully available to the public. Back in 1999, clinical trials would last for 460 days, and in 2005, clinical trials were lasting for 780 days. It is important to closely investigate and monitor the drug over time to truly understand how it can help, if there are any side effects, and if it will ultimately be harmful or ineffective for too many people to be able to market it for everyone.

The phases of clinical studies

Technically speaking, there are five phases of such a study. It begins with Phase 0, which is the very first introduction of the drug into a person, to start to track what the drug and body do to each other. The last phase, Phase 4, is more of a continuous stage, during which the drug is being monitored as it is being widely sold and used. But the middle phases are probably what you imagine when you think of clinical drug trials.

  • Phase 1

    In Phase 1 clinical trials, experts try out the treatment or drug on a very small group of people for the first time. Usually the group consists of anywhere between 20 and 80 individuals. In this stage researchers are evaluating the safety of the drug, and beginning the process of finding any side effects the drug might cause.
  • Phase 2

    The second phase calls for a larger group of people, around 100 to 300, to take the drug in order to more thoroughly gauge side effects, safety, and effectiveness. As the pool of people grows, more accurate results and conclusions start to be formed.
  • Phase 3

    During the trials in Phase 3, the treatment is given to an even larger group of people. The size of these groups are usually around 1,000 to 3,000 people, and the purpose of this stage is the continued eye on safety and effectiveness, in addition to the comparison of other similar drugs or treatments. The beginning stages of developing proper, safe, and effective administration of the drug forms during this phase.

One survey showed that about 96% of participants in the survey has never been a part of any type of clinical trial. However around 46% of people say that they at least somewhat agree that participating in clinical trials is just as crucial to the general health care system as giving blood is. It is an incredible time to be alive, to witness all of the major advancements and developments that we as a society are capable of, and if it is possible to be a part of a clinical study that helps to advance us even further, why would you not want to contribute?

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