Clinical Research is a systematic study of new drugs in human subjects including therapeutic interventions risk and benefits of newer drugs. The jobs in the clinical trial as Project Manager, Clinical Research Associate, Biostatistician, Principal Investigator, Co- Investigator & Investigator.
Phase1 trials
This is the first time the new drug is administered to small number around 20-80
These studies are usually conducted in healthy volunteer subjects under close supervision of the doctor. These studies are designed to determine the metabolic and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness.
Phase 2 trials
In Phase 2 clinical trials, the study drug or treatment is given to a larger group of people (40-100) to see if it is effective and to further evaluate its safety. Phase 2 includes the early controlled clinical studies conducted to obtain some preliminary data on the effectiveness of the drug for a particular indication or indications in patients with the disease or condition. This phase of testing also helps determine the common short-term side effects and risks associated with the drug
Phase 3 trials
in this phase the trial is conducted on the large group appox. 1000-5000 to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug.
Phase III studies usually compare standard treatments (the treatment most accepted) with treatments that appeared to be good in the small Phase II studies.
Phase 4 trials
Phase 4 trials usually enroll between several hundred to several thousand patients and may be designed to further evaluate safety in large populations; to determine if the drug is effective against other disease states; to test different ways of taking the drug such as tablets, time-release capsules, or syrups; and/or to determine the cost-effectiveness of the new drug relative to traditional other new therapies.
Clinical research associate is a health professional that monitors the progress of a clinical trial on behalf of a company. They design, implement and monitor clinical trials. They prepare presentations and manuscripts of scientific meetings and technical journals.
Clinical research coordinator arranges for a site to conduct a research study, he recruits, and enrolls clinical study participants. They assist the investigator, maintains documentation of the study and dispensation of the drug.
Clinical data managers supervise the data gathered from clinical trials of new medicines. They ensure the accuracy and consistency of the data so that it meets the standards for reporting to official bodies.
Biostatisticians are those who design and analyse clinical trial projects and also coordinate and provide statistical reports of clinical trial projects
