Basics Of Clinical Research Tampa Researchers May Find Beneficial

By Barbara Walker


Research in any field is done with an aim of inventing solutions for various situations based on the field of specialty. In clinical research, scientists work to come up with new and better methods of disease prevention and treatment. It also serves to provide temporary solutions to ensure that patients are kept comfortable while definitive treatment is in the process of being established. In this article we discuss details about clinical research Tampa residents may find meaningful.

As the term suggests, pre-clinical trials come right before the trial itself. The pre-clinical phase aims at establishing a safety framework for use of a drug among participants of the main trial. At this stage, important properties ( also known ad pharmacodynamics and pharmacokinetics) of a given drug are studied. Pharmacodynamics refer to the response of the body to the drug. Such will include, for example, the side effects and maximum safe dose. Pharmacokinetics, on the other hand, define how the drug is absorbed, distributed, metabolized and excreted from the body.

In some instances, medical equipment is usually the one undergoing scientific studies to facilitate diagnosis and treatment of disease. In this case, the device does not need to go through the initial pre-clinical phase as drugs do. Medical devices instead are taken through what is good laboratory practices with the aim of ascertaining whether the equipment is sustainable in the human body and just how safe it is for use.

A more recent step has been introduced to quicken the process of research. This step is simply referred to as phase zero. Only a limited number of individuals are tested. In addition, the drug administered is of levels way below the therapeutic concentration. The idea is to chaff out drug characters that have very minimal chances of being effective later in the trial and subsequently when launched into the market.

Phase one of a study entails testing certain drug concepts on a given number of individuals. These concepts include formulation type, safety and dosing levels. Two to one hundred study subjects are utilized, on average.

Healthy individuals are the most suitable subjects for study. Unfortunately, these same individuals are bound to react negatively to the drug. Some money is usually offered to them to cater for any inconvenience caused. Terminally ill patients as well as patients unable to recover with already approved medication can join in the trial.

In subsequent phases a greater number of participants is engaged. In most cases, more than a hundred people are scrutinized. Efficacy is the factor that is assessed at this point. Of note is that the third phase is usually the most tasking.

The final step is phase four which is mainly a surveillance stage. This step can be used to study additional possibilities such as the effect of certain medication in pregnant women or children. Such special groups are usually hesitant to participate in the earlier stages because of the high risk involved and can only be included after successful tests in healthy adults.




About the Author:



No comments:

Post a Comment