The 3 Week Diet

Do you think that these are the best solutions ?

Facts On Clinical Trials Brandon Fl Researchers Should Know

Filled under:

By Jason Stewart


The process of developing new drugs and other forms of treatment if often a long and tedious one and requires huge financial resources. Pioneer drugs are often subjected to a vigorous testing process known as a clinical trial before they are approved for use in the general population. If they intend on carrying out clinical trials Brandon fl residents need to understand a number of things on the procedure involved.

Any trial is usually preceded by a feasibility study. The drug under development has to undergo several stages of laboratory tests before it can be used in human subjects. This is what is known as preclinical research. The idea here is to determine the effect of the molecule in question on human cells or animal models.

The clinical research proper starts with phase zero. This is the first point at which a drug is given to human subjects. The number of people is usually small (about 15) and the dose of the drug is also quite low. This is to avoid unwanted effects that may not be known yet. It takes a few months to complete.

The next stage is phase one. This is only carried out if phase zero was successful. If the findings were unfavourable the options include making changes on the molecule or abandoning the study. This phase requires several months to be completed. It involves a slightly higher number of people who range from twenty to eighty. The main aim of this stage is to study the safety profile of the drug.

Phase 1 provides the researcher with other important information other than the side effects associated with the drug. Part of this will include the optimum dose that can be used. This is determined by a gradual increase of the dose to the maximum level that can be tolerated. It is also possible to know the most effective route of administration.

About 75 per cent of phase 1 studies usually proceed to the next step. At phase 2, the study participants are a few hundreds. The precondition for one to be considered as a participant is that they should have the medical condition behind controlled by the drug. There are several months of follow up by the researcher to see how effective the drug is in the larger. Data collected are used to make decisions on subsequent stages of study.

The participants enrolled at the third phase are usually several thousands. They too are required to be suffering from the condition for which the drug has been designed. At this stage, the researcher will compare the profile of the new drug with those of other drugs that have been in the market. Participants may receive either the older or the new drug through a randomized allocation system. The results of each drug are then analyzed.

The final phase, four, is conducted after approval of the drug. Just a quarter of phase 3 trials get to this point, on average. The role of this stage is to conduct surveillance with the aim of documenting long term and rare side effects. Many years are required for the completion of this stage.




About the Author:



0 commentaires:

Post a Comment