A Few Concepts On Clinical Research Tampa Residents May Find Worthwhile

By Barbara Walker


There is a huge number of diseases in the world today whose cure has not been found yet. This cure could be in form drugs, technology or even psychological. Even when definitive treatment is not established, scientists have to come up with ways of keeping a given disease under control. These are some of the basics of clinical research Tampa residents may find informative.

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 a situation where it is medical instruments under study, the above stage is skipped. Instead, the trial is taken through good laboratory practices. This stage depends on what the piece of equipment is intended for. In general, some devices are designed to help with diagnosis of disease while others are invented to replace a damaged vital part of the human system. A good example is the pacemaker device which is placed right at the center of the heart to keep it beating in rhythm. Before the device goes to the clinical phase, its effectiveness has to be ascertained.

Phase zero of clinical research is meant to speed up the trial process. It is, however, not considered a platform for testing the safety and toxicity profile of a drug. This is because very small concentrations of the agent are introduced in animal models. The exercise is usually done at a small scale. The ultimate goal is to rule out or rule in the possibility of the agent proceeding to the next stage.

The next thing is to recruit a number of individuals ranging from three to a hundred. The main objective is to evaluate certain concerns including efficacy of a given dosage and the toxicity profile of the agent under study. Whether the agent will be in capsule, tablet or in solution form can also be determined at this point.

Individuals who are healthy are the preferred choice to be used for these studies. People living with advanced cancer are an alternative. Patients who have failed to respond to standard medication are also commonly enrolled in research programs. Ethical guidelines dictate that the individuals signing up for the research receive some financial help to offset any side effects that may occur.

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 fourth and final phase emphasizes on getting the finer details. For instance, certain groups of people that may not have been evaluated in at the preliminary level fit in perfectly at this stage. Expectant women and infants are classic examples.




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