Is very important you have clinical trial registry if involving humans as subjects. It’s based on the declaration of Helsinki, which says that every clinical trial must be registered in a publicly accessible database before recruitment of the first subject. One of the purposes of the registration of research involving human subjects is that all the data can be stored and used by the parties concerned to conduct further research.
The intent and purpose of these Articles is merely providing enlightenment, knowledge and understanding for us all to learn how, difficult, expensive and long time needed to launch a medicine for the human beings.
Basically clinical trials to ensure the effectiveness, safety and adverse-event that often arise in humans due of a medicine. The clinical trial consisted of a phase I up to phase IV.
This phase is the testing of a new medicine for the first time in humans. It is usually performed in healthy volunteers. The first objective of this phase is to determine amount of a single dose and ensuring not cause serious effects.
In this phase the medicine tested for the first time on a small group of patients who would be treated with the medicine candidate. The goal is to see whether the pharmacologic effects seen in the first phase for ensuring the treatment is useful or not. Phase II was carried out by people who are experts in their respective fields. They are having had a role in making the research protocol to be assessed first by the local ethics committee. The study protocol should be followed strictly, patient selection must be careful, and each patient should be monitored intensively.
Phase III clinical trials conducted to ensure that a new medicine is really efficacious and to determine position and compare with standard medicines. This research also will answer questions about the effect when it is used widely, other effects that have not been seen in phase II, and the impact of use in patients.
When the results of the phase III clinical trials show that a new medicine is reasonably safe and effective, the medicine can be allowed to be marketed. Number of patients included with this third phase at least 500 people.
This phase is often referred to as post- marketing medicine surveillance is an examination of the medicine has been marketed. This phase aims to determine patterns of medicine use in the community as well as the pattern of effectiveness and safety in actual use.
Phase IV studies are epidemiologic survey about the effects and effective’s medicine. In phase IV can be observed the low frequency effects or arising after use of the medicine for years , the effectiveness of the medicine in patients with severe disease or double disease , expectant, children or the elderly , or after repeated use in the term length, medicine abuse, the problem overuse, and others.
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