Important Aspects Of Clinical Trials Brandon Fl Researchers Should Understand

By Jason Stewart

Before a drug is approved for human use, it has to undergo several stages of development. This usually takes years and tremendous amounts of resources. A drug must pass all the safety measures and indeed, it must be effective. This process is what is commonly termed a clinical trial and comprises several steps. If they have plans of carrying out clinical trials Brandon fl researchers must understand all the stages involved beforehand.

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.

A successful phase zero allows for the commencement of phase 1. If unwanted effects are noted, however, more research at the preclinical stage is warranted. Phase 1 is typically carried out over several months. The main objective is to determine the effects of the drug (or any other intervention) on the test subjects. The number of people enrolled here ranges from 20 and 80.

Phase one is also important in several other respects other than side effect profiling. For instance, it is the period during which the effective dosage is determined. This is done by gradually increasing the amount administered to subjects and monitoring the side effects. The optimal dose is the highest that can be given without resulting in serious side effects. The route of administration can also be determined at this time.

Roughly three quarters of phase one studies move to the next stage. The number of participants is increased to hundreds in phase 2. It is a requirement that all the participants have the condition or illness that is being treated by the drug. This helps in assessing drug effectiveness. Several months of follow up are needed so as to collect enough data.

The third phase is made up of a few thousand participants. They also have a medical condition targeted by the drug. The main role of this stage is to compare and contrast the effects of the new drug with those of pre-existing molecules used for the same condition. Participants receive either the existing drug or the new one in random fashion. The concept of double blinding is also employed to eliminate bias by the researchers and participants.

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.

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