| What is Clinical Research?
Clinical Research is a systematic study for new drugs in human subjects to generate data for discovering or verifying the Clinical, Pharmacological (including pharmacodynamic and pharmacokinetic) with the objective of determining safety and efficacy of the new drug.
Phases of Clinical Research:
Phase I:
This is the first time the new drug is administered to a small number, around 20-80 healthy, informed volunteers under the close supervision of a doctor. The purpose is to determine whether the new compound is tolerated by the patient’s body and behaves in the predicted way.
Phase II:
In this phase, the medicine is administered to a group of approximately 100-300 informed patients to determine its effect and also to check for any unacceptable side effects.
Phase III:
In this phase, the group is between 1000 and 5000, for the company to use statistics to analyze the results. If the results are favorable, the data is presented to the licensing authorities for a commercial license.
Phase IV:
This is a surveillance operation phase after the medicine is made available to doctors, who start prescribing it. The effects are monitored on thousands of patients to help identify any unforeseen side effects.
Managements of Clinical Trails
• Drug Safety Post Marketing studies, PSUR, package inserts
• Overview Project managements, objectives, task network
• Project Resource Resource and supplies, drug supplies, distribution
• Finances Budgeting, Costing, Over Runs, Insurance
• Non Compliance Misconduct and fraud, detection and management
• Trial monitoring Objectives, Procedures, Reporting |
