Clinical Research, an emerging branch of medical science, determines the safety and effectiveness of medications, devices, diagnostic products and treatment regiments that are intended for the human use. It may also be used for prevention, treatment and relief of symptoms in a disease. This has the clear potential for the strong growth in the future that driven by technological and scientific advances.
In Clinical Research, we do a systematic study for new drugs in human subjects to generate data for verifying or discovering the Clinical, Pharmacological or adverse effects to determine the safety and efficacy of the new drug. For this purpose, it conducts four phases.
1) Phase 1 trials: – The first phase of trial usually deals with the trial of the medicine in a small number of people such as health volunteers under the close supervision of a doctor. The main purpose of this trial is to determine whether the new compound is tolerated by body of the patient and behaves in the predicted way.
2) Phase 2 trials: – In the second phase, the medicine is administered to a group of about 100 to 300 informed patients for determining its effects. It also checks for any unacceptable side effects of the product.
3) Phase 3 trials: – The third phase is usually multi-centric phase that deals with the trial on the more than 1000 patients. This phase focuses on the effects of drugs in various ethnic groups, as compared to the standard drugs on the market and it also study of the drug effect on the different variants of the disease.
4) Phase 4 trials: – This phase is conducted after the launch of the drug on the market. It is a surveillance operation phase after the medicine is made available to the doctors who start prescribing it. The aim of this phase is to identify newer and to unknown adverse reactions and effects in different ethnic groups. This entire journey of a drug from the lab to market may take approx. 12 to 18 years.
By concluding, we can say that the main focus of clinical research is enough to include data management, medical writing, regulatory consultation and biostatistics to name a few.
No Comments Found